U.S. patent application number 12/723341 was filed with the patent office on 2010-07-22 for systems and methods for closing an aperture in a bodily tissue.
This patent application is currently assigned to CVDevices, LLC. Invention is credited to Ghassan S. Kassab, Jose A. Navia, SR..
Application Number | 20100185235 12/723341 |
Document ID | / |
Family ID | 39926280 |
Filed Date | 2010-07-22 |
United States Patent
Application |
20100185235 |
Kind Code |
A1 |
Kassab; Ghassan S. ; et
al. |
July 22, 2010 |
SYSTEMS AND METHODS FOR CLOSING AN APERTURE IN A BODILY TISSUE
Abstract
Systems and methods for closing an aperture in a bodily tissue.
In at least one embodiment of a system for closing an aperture in a
targeted mammalian tissue, the system comprises a first catheter
having a lumen defined therethrough, a coil positioned within the
lumen of the first catheter, and a shaft positioned within the
lumen of the catheter, the shaft operable to position the coil at
the targeted tissue, wherein the coil may be positioned within the
aperture of the targeted tissue to close said aperture.
Inventors: |
Kassab; Ghassan S.;
(Zionsville, IN) ; Navia, SR.; Jose A.; (Buenos
Aires, AR) |
Correspondence
Address: |
ICE MILLER LLP
ONE AMERICAN SQUARE, SUITE 3100
INDIANAPOLIS
IN
46282-0200
US
|
Assignee: |
CVDevices, LLC
Zionsville
IN
|
Family ID: |
39926280 |
Appl. No.: |
12/723341 |
Filed: |
March 12, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12596972 |
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PCT/US08/60870 |
Apr 18, 2008 |
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12723341 |
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Current U.S.
Class: |
606/215 |
Current CPC
Class: |
A61M 2025/0039 20130101;
A61M 2210/122 20130101; A61B 2017/00628 20130101; A61B 2017/00606
20130101; A61M 25/0141 20130101; A61M 2210/125 20130101; A61M
25/0074 20130101; A61M 2205/32 20130101; A61B 2017/308 20130101;
A61M 60/268 20210101; A61B 2017/003 20130101; A61M 60/122 20210101;
A61M 2025/004 20130101; A61M 2025/0681 20130101; A61M 25/0084
20130101; A61M 60/857 20210101; A61B 2017/00592 20130101; A61M
2205/3331 20130101; A61B 2017/00247 20130101; A61B 2017/00584
20130101; A61M 25/003 20130101; A61M 2205/33 20130101; A61B
2017/00601 20130101; A61B 17/0057 20130101; A61B 2018/00392
20130101; A61M 2025/0036 20130101; A61M 25/00 20130101; A61M 25/06
20130101; A61M 2205/3303 20130101; A61B 90/37 20160201; A61M
2025/0096 20130101; A61M 2025/015 20130101; A61M 25/0136 20130101;
A61M 60/40 20210101; A61M 60/871 20210101; A61B 2017/306 20130101;
A61M 25/0147 20130101; A61M 25/0054 20130101; A61M 60/50 20210101;
A61M 2230/005 20130101; A61M 2025/0089 20130101; A61N 1/0587
20130101 |
Class at
Publication: |
606/215 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1. A method for closing an aperture in a targeted mammalian tissue,
the method comprising the steps of: introducing a catheter to the
targeted tissue, the catheter having a lumen defined therethrough;
inserting a coil within the lumen of the catheter; inserting a
shaft within the lumen of the catheter, the shaft operable to
position the coil at a targeted tissue; and positioning the coil
within the aperture of the targeted tissue, wherein at least part
of the coil is present on a first side of the targeted tissue, and
wherein at least part of the coil is present on a second side of
the targeted tissue.
2. The method of claim 1, wherein the coil comprises a first
configuration and a second configuration.
3. The method of claim 2, wherein the first configuration is
uncompressed, and wherein the second configuration is
compressed.
4. The method of claim 2, further comprising the step of pushing
the coil using the shaft so that the changes from a first
configuration to a second configuration.
5. The method of claim 1, further comprising the step of pushing
the coil using the shaft so that the coil compresses to close the
aperture of the targeted tissue.
6. The method of claim 1, further comprising the step of twisting
the coil using the shaft so that the coil compresses to close the
aperture of the targeted tissue.
7. The method of claim 1, wherein the targeted tissue is an atrial
wall of a heart.
8. The method of claim 1, wherein the step of inserting a coil
within the lumen of the catheter comprises the step of inserting a
guide wire within the lumen of the catheter prior to insertion of
the coil so that the guide wire may facilitate insertion of the
coil.
9. The method of claim 1, wherein the step of positioning the coil
results in closure of the aperture of the targeted tissue.
10. The method of claim 1, wherein the step of introducing a
catheter to the targeted tissue further comprises engagement of the
targeted tissue by the catheter.
11. A system for closing an aperture in a targeted mammalian
tissue, the system comprising: a first catheter having a lumen
defined therethrough; a coil positioned within the lumen of the
first catheter; and a shaft positioned within the lumen of the
catheter, the shaft operable to position the coil at the targeted
tissue; wherein the coil may be positioned within an aperture of
the targeted tissue to close said aperture.
12. The system of claim 11, wherein the coil is radiopaque.
13. The system of claim 11, wherein the first catheter comprises a
delivery catheter, and wherein the coil and the shaft are
positioned within the delivery catheter.
14. The system of claim 13, further comprising a second catheter
having a lumen defined therethrough, wherein the second catheter
comprises an engagement catheter, and wherein the delivery catheter
is positioned within the lumen of the engagement catheter.
15. The system of claim 11, wherein when the coil is positioned
within the aperture of the targeted tissue, at least part of the
coil is present on a first side of the targeted tissue, and at
least part of the coil is present on a second side of the targeted
tissue.
16. The system of claim 11, wherein the coil comprises a memory,
and wherein the memory comprises a first configuration and a second
configuration.
17. The system of claim 16, wherein the first configuration is
uncompressed, and wherein the second configuration is
compressed.
18. The system of claim 16, wherein the shaft is further operable
to push the coil so that the coil changes from a first
configuration to a second configuration.
19. The system of claim 11, wherein the shaft is further operable
to push the coil so that the coil compresses to close the aperture
of the targeted tissue.
20. The system of claim 11, wherein the shaft is further operable
to twist the coil so that the coil compresses to close the aperture
of the targeted tissue.
21. The system of claim 11, wherein the targeted tissue is an
atrial wall of a heart.
22. The system of claim 11, further comprising a guide wire
positioned within the lumen of the catheter prior to positioning
the coil within the lumen of the catheter so that the guide wire
may facilitate positioning of the coil.
23. The system of claim 14, wherein the engagement catheter is
operable to engage the targeted tissue.
24. A system for closing an aperture in a targeted mammalian
tissue, the system comprising: an engagement catheter having a
lumen defined therethrough; a delivery catheter having a lumen
defined therethrough, the delivery catheter positioned within the
lumen of the engagement catheter; a coil positioned within the
lumen of the delivery catheter, the coil comprising a first
configuration and a second configuration; and a shaft positioned
within the lumen of the catheter, the shaft operable to position
the coil at a targeted tissue; wherein the coil may be positioned
within an aperture of the targeted tissue to close said aperture.
Description
PRIORITY
[0001] This U.S. continuation patent application is related to, and
claims the priority benefit of, U.S. Nonprovisional patent
application Ser. No. 12/596,972, filed Oct. 21, 2009, which is
related to, claims the priority benefit of, and is a U.S. national
stage application of, International Patent Application No.
PCT/US2008/060870, filed Apr. 18, 2008, which (i) claims priority
to International Patent Application No. PCT/US2008/053061, filed
Feb. 5, 2008, International Patent Application No.
PCT/US2008/015207, filed Jun. 29, 2007, and U.S. Provisional Patent
Application Ser. No. 60/914,452, filed Apr. 27, 2007, and (ii) is
related to, claims the priority benefit of, and in at least some
designated countries should be considered a continuation-in-part
application of, International Patent Application No.
PCT/US2008/056666, filed Mar. 12, 2008, which is related to, claims
the priority benefit of, and in at least some designated countries
should be considered a continuation-in-part application of,
International Patent Application No. PCT/US2008/053061, filed Feb.
5, 2008, which is related to, claims the priority benefit of, and
in at least some designated countries should be considered a
continuation-in-part application of, International Application
Serial No. PCT/US2007/015207, filed Jun. 29, 2007, which claims
priority to U.S. Provisional Patent Application Serial No.
60/914,452, filed Apr. 27, 2007, and U.S. Provisional Patent
Application Ser. No. 60/817,421, filed Jun. 30, 2006, The contents
of each of these applications are hereby incorporated by reference
in their entirety into this disclosure.
BACKGROUND
[0002] Ischemic 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.
[0003] 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.
[0004] 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.
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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).
[0009] 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.
[0010] 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.
[0011] 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. and Freeman G. L. (2006).
"Pericardial Disease," Circulation 113(12): 1622-1632.
[0012] 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.
[0013] 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. et al,
(2006). "Pericardial Effusion."
http://www.emedicine.com/med/topic1786.htm,
[0014] 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. et al. (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., Seferovic P. M., Ristic A. D., Erbel
R., Rienmuller R., Adler Y., Tomkowski W. Z., Thiene G., Yacoub M.
H., ESC Committee for Practice Guidelines, Priori S. G., Alonso
Garcia M. A., Blanc J.-J., Budaj A., Cowie M., Dean V., Deckers J.,
Fernandez Burgos E., Lekakis J., Lindahl B., Mazzotta G., Moraies
J., Oto A., Smiseth O. A., Document Reviewers, Acar J., Arbustini
E., Becker A. E., Chiaranda G., Hasin Y., Jenni R., Klein W., Lang
I., Luscher T. F., Pinto F. J., Shabetai R., Simoons M. L., Soler
Soler J., Spodick D. H. (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.
[0015] 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.
[0016] 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.
[0017] 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. et al. (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.
[0018] 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. et al, (2003). "Pericardiocentesis with extended catheter
drainage: an effective therapy." Ann. Thorac. Surg. 76(3):
817-82.
[0019] 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).
[0020] 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. et al.
(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. et al., 2003,
[0021] Currently, 0.2% of the U.S. population over 45 years of age
(nearly 200,000 patients) have reached a stage of severe congestive
heart failure (CHF) at which medical therapy is not sufficient to
sustain an acceptable level of cardiac function. Since only
approximately 2,000 donor hearts are available in the U.S. each
year for transplantation, it is necessary to have cardiac support
or replacement. Baughman K. L, and Jarcho J. A. (2007). "Bridge to
Life--Cardiac Mechanical Support." N. Engl. J. Med. 357(9):
846-849.
[0022] Although there has been important progress in
pharmacological treatments for CHF, such as Angiotensin-Converting
Enzyme (ACE) inhibitors, beta-blockers, and aldosterone inhibitors
that have significantly decreased mortality, the progression from
asymptomatic left ventricular dysfunction to symptomatic CHF is
still a major issue. Mancini D. and Burkhoff D. (2005), "Mechanical
Device-Based Methods of Managing and Treating Heart Failure."
Circulation 112(3): 438-448.
[0023] The purpose of many heart failure treatments is to slow, or
reverse, the process. Several studies have demonstrated that a
pharmacological blockade of the key neurohormonal pathways
interrupts the vicious cycle, retards progression, and improves
survival. Nevertheless, studies suggest that attempts to block
additional neurohormonal pathways may be detrimental. These
findings underscore the limit of pharmacological treatments for
heart failure. Id.
[0024] Regarding devices for treatment of CHF, there have been
extensive efforts to develop and test device-based therapies for
patients with both acute and chronic heart failure. For example,
cardiac resynchronization therapy (CRT), myogenesis (e.g., stem
cells and myoblasts) and electrical therapies, such as less
invasive defibrillators, are under active investigation. Surgical
reshaping of the dilated heart, including a reduction in the radius
of curvature, can decrease wall stress, in principle allowing for
reverse remodeling. Removal of dyskinetic scar is clinically
accepted and reported to be associated with satisfactory outcomes.
The effects of removing akinetic scar (often referred to as the Dor
procedure or surgical anterior ventricular restoration (SAVR) are
also under investigation. Another method proposed to decrease wall
stress and to induce reverse remodeling is by passive ventricular
restraint devices. This concept evolved from an earlier
investigational approach called cardiomyoplasty. Id.
[0025] In order to treat symptoms of heart failure due to mitral
insufficiency, numerous catheter-based devices are being developed
to perform mitral valve repair percutaneously to reduce risk as a
non-invasive procedure. Id.
[0026] For over 40 years, many researchers have pursued the
development of mechanical cardiac support. The earliest forms of
clinical use were introduced in 1953 by the cardiopulmonary bypass,
and was used for cardiopulmonary support during cardiac surgery. In
1962, the intra-aortic balloon counterpulsation was introduced and
used for temporary partial hemodynamic support improving myocardial
contractility and coronary perfusion. Neither approach provides
full cardiac replacement, however, even temporarily, as each
approach is limited by the invasive nature of the procedure, e.g.
the requirement for large-bore cannulation of the femoral
circulation limits the patient's mobility and restricts functional
recovery. Risks of bleeding, thromboembolism, and infection also
limit the feasible duration of support. Baughman and Jarcho,
2007.
[0027] The intra-aortic balloon pump (IABP) is the most widely used
of all circulatory assist devices. Counterpulsation improves left
ventricular (LV) performance by enhancing myocardial oxygen
balance. It increases myocardial oxygen supply by diastolic
augmentation of coronary perfusion and decreases myocardial oxygen
requirements through a reduction in the afterload component of
cardiac work. Azevedo C. F, et al, (2005). "The effect of
intra-aortic balloon counterpulsation on left ventricular
functional recovery early after acute myocardial infarction: a
randomized experimental magnetic resonance imaging study." Eur.
Heart J. 26(12): 1235-1241,
[0028] Support for the use of IABP in patients with acute
myocardial infarction (AMI) has been based on the above theoretical
consideration. However, the relationship between the beneficial
physiological effect of counterpulsation and post-AMI LV functional
recovery remains largely undefined. In fact, several studies have
investigated the immediate effect of IABP on LV performance and
demonstrated that, during counterpulsation, there is a significant
improvement in LV haemodynamics.
[0029] An important difference exists between the improved
haemodynamics provided by counterpulsation itself and the possible
favorable effect on post-AMI non-assisted LV contractility. Id.
Furthermore, it is important to highlight that at twenty-four hours
after reperfusion, the degree of functional recovery was similar
with or without IABP counterpulsation. Therefore, even though IABP
counterpulsation may have an important role in supporting and
improving the clinical status of patients in the early phases of
reperfused AMI, it does not seem to have a significant beneficial
effect in terms of long-term LV functional improvement. Id,
[0030] The available forms of mechanical cardiac support are
devices known as pumps that can be classified into three types:
centrifugal pumps, volume-displacement pumps, and axial-flow pumps.
Moreover, three distinct clinical indications for mechanical
cardiac support have been defined. Temporary support is instituted
when recovery of native heart function is expected. Among patients
who are candidates for heart transplantation but who may not
survive the waiting period for a transplant, a ventricular assist
device may be used as a "bridge to transplantation." Ultimately,
for patients who are not candidates for heart transplant and for
whom recovery of cardiac function is not probable, a mechanical
device may be utilized as "destination therapy"; i.e., as a
permanent replacement for the native heart. This last indication
has only recently been established in clinical practice but is
expected to be of growing importance in the future. Baughman and
Jarcho, 2007,
[0031] Despite the wide variety of pumps currently available, the
problems associated with this technology have not changed since the
early years of development. Id. Available devices for circulatory
support use numerous blood contacting pumps to assist the failing
heart. Blood removed from the venous circulation is injected into
the arterial circuit in order to increase organ perfusion.
Unfortunately, blood contact remains the core for major
complications generally associated with mechanical circulatory
support. Thromboembolic events, the need for anticoagulation,
bleeding, hemolysis, immune suppression, and activation of the
inflammatory system are factors which continue to threaten those
requiring this therapy. Moreover, device implantation can be
difficult and time-consuming which limits feasibility when
cardiovascular collapse occurs suddenly. These unsolved problems
provide continued motivation to develop non-blood contacting
circulatory support devices. Instead of unloading the heart,
mechanical forces are directed toward increasing pump performance
of the ventricular wall. Anstadt M. P. et al. (2002). "Non-blood
contacting biventricular support for severe heart failure." Ann.
Thorac. Surg. 73(2): 556-562. These complex problems may be
circumvented by a fundamentally different approach to cardiac
assist.
[0032] Among all organs, the heart is unique in that oxygen
extraction is nearly close to maximal. Thus, the only way that this
metabolically demanding organ can increase oxygen consumption is by
increasing coronary blood flow. In this aspect of oxygen delivery,
the heart is also unique because most flow occurs in diastole
instead of in systole. Carabello B. A. (2006). "Understanding
Coronary Blood Flow: The Wave of the Future." Circulation 113(14):
1721-1722." The compression of the vasculature by the surrounding
cardiac muscle during systole impedes flow so that while the
pressure head for flow is maximum in systole, flow is maximum in
diastole.
[0033] Waves are generated from both ends of the coronary
vasculature, in that proximal waves move forward and distal waves
move backward. In this scheme, proximal "pushing" waves and distal
"suction" waves accelerate forward blood flow, while proximal
suction waves and distal pushing waves do the converse. Carabello,
B. A., 2006. The forward-moving pushing wave is generated by
systolic pressure. It drives blood primarily into the epicardial
coronaries where it may be stored until it is released for forward
flow when the myocardium relaxes. The second important wave,
typically the largest, is a suction wave generated by relaxation of
the left ventricle and is likely the main driver in diastolic
coronary blood flow. Id.
[0034] Among patients with ischemic heart disease, it is of great
importance to improve the microvascular blood flow in the
myocardium to protect the myocardium from infarction. Today, many
different drugs and sophisticated techniques, such as percutaneous
coronary intervention (PCI) and coronary artery bypass graft
(CABG), are used with remarkable results, Despite this, there is a
large group of patients who have been heavily treated with
different drugs (leading to drug-resistant angina pectoris) who
have already undergone one or more PCIs or CABG, or both, and who
still have serious ischemic heart disease. A satisfactory mode of
treatment for these patients has yet to be found. Lindstedt S. et
al, (2007). "Blood Flow Changes in Normal and Ischemic Myocardium
During Topically Applied Negative Pressure," Ann. Thorac. Surg.
84(2): 568-573.
[0035] Despite the extensive clinical use and excellent outcome of
topical negative pressure (TNP) in wound therapy, the fundamental
scientific mechanism is, to a large extent, unknown. One of the
known effects of TNP is enhanced blood flow to the wound edge, as
has been shown in a sternotomy wound model. TNP increases blood
flow velocity and opens up the capillary beds. Mechanical forces
exerted by TNP and increased blood flow affect the cytoskeleton in
the vascular cells and stimulate granulation tissue formation,
which involves endothelial proliferation, capillary budding, and
angiogenesis. Id.
[0036] As described herein, studies have shown that when myocardium
was exposed to a topical negative pressure of -50 mm Hg, an
immediate significant increase in microvascular blood flow was
observed. To investigate whether similar results could be obtained
in an ischemic model, the LAD was occluded for 20 minutes. When the
ischemic area of the myocardium was exposed to a topical negative
pressure of -50 mm Hg, an immediate significant increase in
microvascular blood flow was detected. Furthermore, after 20
minutes of reperfusion, myocardial blood flow significantly
increased when -50 mm Hg was applied, Lindstedt S. et al. (2007).
Similar findings have been made with TNP of -25 mmHg.
[0037] TNP stimulation of myocardial blood flow may be a possible
therapeutic intervention. It is believed that the sheering forces
exerted by TNP stimulate angiogenesis. It has been observed in
patients treated with TNP that richly vascularized granulation
tissue develops over the heart within 4 to 5 days. These newly
formed blood vessels may provide collateral blood supply that is
needed when the native circulation fails to provide sufficient
blood flow. It may be that the TNP stimulation of blood flow and
development of collateral blood vessels in part accounts for the
reduced long-term mortality in patients treated with TNP for
poststernotomy mediastinitis after CABG. Lindstedt S. et al.
(2007).
[0038] The pericardium is a conical fibro-serous sac, in which the
heart and the roots of the great vessels are contained. The heart
is placed behind the sternum and the cartilages of the third to
seventh ribs of the left side, in the mediastinal cavity. Gray H.
(1918). "Anatomy of the Human Body." Philadelphia: Lea &
Febiger; Bartleby.com, 2000, pp. 1821-1865. The pericardium is
separated from the anterior wall of the thorax, in the greater part
of its extent, by the lungs and pleurae. However, a small area,
somewhat variable in size and usually corresponding with the left
half of the lower portion of the body of the sternum and the medial
ends of the cartilages of the fourth and fifth ribs of the left
side, comes into direct relationship with the chest wall. Behind,
the pericardial sac rests upon the bronchi, the esophagus, the
descending thoracic aorta, and the posterior part of the
mediastinal surface of each lung. Laterally, it is covered by the
pleurae, and is in relation with the mediastinal surfaces of the
lungs. The phrenic nerve, with its accompanying vessels, descends
between the pericardium and pleura on either side. Id.
[0039] Similar to synovial joints in which moving surfaces may be
separated by a thin fluid film at different stages of stance and
walking, the heart and pericardium might be viewed as a
load-bearing system in which deformable epicardial and pericardial
sliding surfaces are separated by a lubricant. deVries G. et al.
(2001). "A novel technique for measurement of pericardial
pressure." Am. J. Physiol, Heart Circ. Physiol.
280(6):142815-22.
[0040] The role played by the pericardium in cardiac hemodynamics
is important. Almost a century ago, Barnard concluded that the
pericardium can be a significant constraint in filling of the
heart. Barnard H. (1898). "The functions of the pericardium." J.
Physiol, 22: 43-47. In a simple experiment, he isolated and
inflated the pericardium of a dog with a bicycle pump and observed
that it did not rupture until pressures of 950 to 1330 mm Hg.
According to Barnard, "when a relaxed heart is subject to a venous
pressure of from 10 to 20 mm Hg, the pericardium takes the strain
and prevents dilatation of the heart beyond a certain point. Thus
the mechanical disadvantages of dilated cavities and of a thinned
wall are prevented." Hamilton D. R, et al. (1994). "Right atrial
and right ventricular transmural pressures in dogs and humans.
Effects of the pericardium." Circulation 90(5): 2492-500.
[0041] Gibbons Kroeker et al. showed that direct interaction
between the left ventricle (LV) and right ventricle (RV) is
mediated by the pericardium, as shown by a pericardium-mediated
compensation for sudden changes in atrial volume, Gibbons Kroeker
et al. (2006). "A 2D FE model of the heart demonstrates the role of
the pericardium in ventricular deformation." Am. J. Physiol, Heart,
Circ. Physiol. 291(5): H2229-36. At low strains, the pericardium is
extremely distensible, but when strains are greater than ten
percent, the pericardium becomes very stiff. Consequently, over a
range of lower heart volumes, the pericardium will expand easily
with the heart as it fills. At some point, however, it will stiffen
and become an ever tighter ring around the minor axis of the heart,
resisting further expansion. Id.
[0042] Local contact forces between the pericardium and the heart
cause regional variation in pericardial deformation during the
cardiac cycle, reflecting volume changes of the underlying cardiac
chambers. Goto Y. and LeWinter M. M. (1990). "Nonuniform regional
deformation of the pericardium during the cardiac cycle in dogs."
Circ. Res, 67(5): 1107-14. The measured left ventricular diastolic
pressure is equal to the sum of the pressure differences across the
myocardium and the pericardium. Thus, increases in pericardial
pressure raise measured ventricular diastolic pressure without
change in ventricular volume which causes an upward shift in the
pressure-volume curve. Tyberg J. V, et al. (1978). "A mechanism for
shifts in the diastolic, left ventricular, pressure-volume curve:
the role of the pericardium." Eur. J. Cardiol, 7 Suppl: 163-75.
[0043] Noble gases, also known as the helium family or the neon
family, are the elements in group 18 of the periodic table. Noble
gases rarely react with other elements since they are already
stable. Under normal conditions, they are odorless, colorless,
monatomic gases, each having its melting and boiling points close
together so that only a small temperature range exists for each
noble gas in which it is a liquid. Noble gases have numerous
important applications in lighting, welding and space technology.
The seven noble gasses are: helium, neon, argon, krypton, xenon,
radon, and ununoctium.
[0044] Helium (He) is a colorless, odorless, tasteless, non-toxic,
inert monatomic chemical element that heads the noble gas series in
the periodic table and whose atomic number is 2. The boiling and
melting points are the lowest among the elements and it exists only
as a gas except in extreme conditions, Helium is less water soluble
than any other gas known, and it does not have any measurable
viscosity because the speed of sound in helium is nearly three
times the speed of sound in air,
[0045] Neutral helium at standard conditions is non-toxic, plays no
biological role, and is found in trace amounts in human blood. The
addition of helium to a gas mixture prevents the occurrence of
ventricular fibrillation. Helium has a definite protective effect
against ventricular fibrillation when this preparation is used. The
mechanism of the protective effect remains to be established. It is
believed that helium may increase collateral circulation in the
ischemic area. Pifarre R. et al. (1969). "Helium in the Prevention
of Ventricular Fibrillation." Chest 56(2): 135-138.
[0046] Clearly, there is a clinical need for a safe and effective
approach to treat patients with congestive heart failure.
BRIEF SUMMARY
[0047] According to at least one embodiment of a method for closing
an aperture in a targeted mammalian tissue, the method comprises
the steps of introducing a catheter to the targeted tissue, the
catheter having a lumen defined therethrough, inserting a coil
within the lumen of the catheter, inserting a shaft within the
lumen of the catheter, the shaft operable to position the coil at
the targeted tissue, and positioning the coil within the aperture
of the targeted tissue, wherein at least part of the coil is
present on a first side of the targeted tissue, and wherein at
least part of the coil is present on a second side of the targeted
tissue. In another embodiment, the coil comprises a first
configuration and a second configuration. In yet another
embodiment, the first configuration is uncompressed, and wherein
the second configuration is compressed. In an additional
embodiment, the method further comprises the step of pushing the
coil using the shaft so that the coil changes from a first
configuration to a second configuration. In yet an additional
embodiment, the method further comprises the step of pushing the
coil using the shaft so that the coil compresses to close the
aperture of the targeted tissue.
[0048] According to at least one embodiment of a method for closing
an aperture in a targeted tissue, the method further comprises the
step of twisting the coil using the shaft so that the coil
compresses to close the aperture of the targeted tissue. In another
embodiment, the targeted tissue is an atrial wall of a heart. In
yet another embodiment, the step of inserting a coil within the
lumen of the catheter comprises the step of inserting a guide wire
within the lumen of the catheter prior to insertion of the coil so
that the guide wire may facilitate insertion of the coil. In an
additional embodiment, the step of positioning the coil results in
closure of the aperture of the targeted tissue. In yet an
additional embodiment, the step of introducing a catheter to the
targeted tissue further comprises engagement of the targeted tissue
by the catheter.
[0049] According to at least one embodiment of a system for closing
an aperture in a targeted mammalian tissue, the system comprises a
first catheter having a lumen defined therethrough, a coil
positioned within the lumen of the catheter, and a shaft positioned
within the lumen of the catheter, the shaft operable to position
the coil at the targeted tissue, wherein the coil may be positioned
within the aperture of the targeted tissue to close said aperture.
In at least one embodiment, the coil is radiopaque. In another
embodiment, the first catheter comprises a delivery catheter, and
wherein the coil and the shaft are positioned within the delivery
catheter. In yet another embodiment, the system further comprises a
second catheter having a lumen defined therethrough, wherein the
second catheter comprises an engagement catheter, and wherein the
delivery catheter is positioned within the lumen of the engagement
catheter. In an additional embodiment, when the coil is positioned
within the aperture of the targeted tissue, at least part of the
coil is present on a first side of the targeted tissue, and at
least part of the coil is present on a second side of the targeted
tissue. In yet an additional embodiment, the coil comprises a first
configuration and a second configuration.
[0050] According to at least one embodiment of a system for closing
an aperture in a targeted tissue, the first configuration is
uncompressed, and wherein the second configuration is compressed.
In another embodiment, the shaft is further operable to push the
coil so that the coil changes from a first configuration to a
second configuration. In yet another embodiment, the shaft is
further operable to push the coil so that the coil compresses to
close the aperture of the targeted tissue. In an additional
embodiment, the shaft is further operable to twist the coil so that
the coil compresses to close the aperture of the targeted tissue.
In yet an additional embodiment, the targeted tissue is an atrial
wall of a heart.
[0051] According to at least one embodiment of a system for closing
an aperture in a targeted tissue, the system further comprises a
guide wire positioned within the lumen of the catheter prior to
positioning the coil within the lumen of the catheter so that the
guide wire may facilitate positioning of the coil. In another
embodiment, the engagement catheter is operable to engage the
targeted tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0052] FIG. 1A shows an embodiment of an engagement catheter and an
embodiment of a delivery catheter as disclosed herein;
[0053] FIG. 1B shows a percutaneous intravascular pericardial
delivery using another embodiment of an engagement catheter and
another embodiment of a delivery catheter as disclosed herein;
[0054] FIG. 2A shows a percutaneous intravascular technique for
accessing the pericardial space through a right atrial wall or
atrial appendage using the engagement and delivery catheters shown
in FIG. 1A;
[0055] FIG. 2B shows the embodiment of an engagement catheter shown
in FIG. 2A;
[0056] FIG. 2C shows another view of the distal end of the
engagement catheter embodiment shown in FIGS. 2A and 2B;
[0057] FIG. 3A shows removal of an embodiment of a catheter as
disclosed herein;
[0058] FIG. 3B shows the resealing of a puncture according to an
embodiment as disclosed herein;
[0059] FIG. 4A to 4C show a closure of a hole in the atrial wall
using an embodiment as disclosed herein;
[0060] FIG. 4D shows another closure of a hole in cardiac tissue
using another embodiment as disclosed herein;
[0061] FIG. 4E shows yet another closure of a hole in cardiac
tissue using another embodiment as disclosed herein;
[0062] FIG. 4F shows still another closure of a hole in cardiac
tissue using another embodiment as disclosed herein;
[0063] FIG. 5A shows an embodiment of an engagement catheter as
disclosed herein;
[0064] FIG. 5B shows a cross-sectional view of the proximal end of
the engagement catheter shown in FIG. 5A;
[0065] FIG. 5C shows a cross-sectional view of the distal end of
the engagement catheter shown in FIG. 5A;
[0066] FIG. 5D shows the engagement catheter shown in FIG. 5A
approaching a heart wall from inside of the heart;
[0067] FIG. 6A shows an embodiment of a delivery catheter as
disclosed herein;
[0068] FIG. 6B shows a close-up view of the needle shown in FIG.
6A;
[0069] FIG. 6C shows a cross-sectional view of the needle shown in
FIGS. 6A and 6B;
[0070] FIG. 7 shows an embodiment of a delivery catheter as
disclosed herein;
[0071] FIG. 8 shows an embodiment of a steering wire system within
a steering channel;
[0072] FIG. 9A shows another embodiment of a steering wire system
as disclosed herein, the embodiment being deflected in one
location;
[0073] FIG. 9B shows the steering wire system shown in FIG. 9A,
wherein the steering wire system is deflected at two locations;
[0074] FIG. 9C shows the steering wire system shown in FIGS. 9A and
9B in its original position;
[0075] FIG. 10 shows a portion of another embodiment of a steering
wire system;
[0076] FIG. 11 shows a cross-sectional view of another embodiment
of a delivery catheter as disclosed herein;
[0077] FIG. 12A shows an embodiment of a system for closing a hole
in cardiac tissue, as disclosed herein;
[0078] FIG. 12B shows another embodiment of a system for closing a
hole in cardiac tissue, as disclosed herein;
[0079] FIG. 12C shows another embodiment of a system for closing a
hole in cardiac tissue, as disclosed herein;
[0080] FIG. 13 shows another embodiment of a system for closing a
hole in cardiac tissue, as disclosed herein;
[0081] FIG. 14 shows another embodiment of a system for closing a
hole in cardiac tissue, as disclosed herein;
[0082] FIG. 15A shows another embodiment of a system for closing a
hole in cardiac tissue, as disclosed herein;
[0083] FIG. 15B shows the embodiment of FIG. 15A approaching
cardiac tissue;
[0084] FIG. 15C shows the embodiment of FIGS. 15A-15C deployed on
the cardiac tissue;
[0085] FIG. 15D shows an embodiment of a system for closing an
aperture in cardiac tissue, as disclosed herein;
[0086] FIG. 15E shows an embodiment of a system for closing an
aperture in cardiac tissue wherein a coil has partially or fully
closed the hole, as disclosed herein;
[0087] FIG. 15F shows an embodiment of a coil of a system for
closing an aperture in cardiac tissue, as disclosed herein;
[0088] FIG. 16A shows an embodiment of a portion of an apparatus
for engaging a tissue having a skirt positioned substantially
within a sleeve, as disclosed herein;
[0089] FIG. 16B shows another embodiment of a portion of an
apparatus for engaging a tissue, as disclosed herein;
[0090] FIG. 16C shows an embodiment of a portion of an apparatus
for engaging a tissue having a skirt positioned substantially
outside of a sleeve, as disclosed herein;
[0091] FIG. 17A shows an embodiment of a portion of an apparatus
for engaging a tissue that has engaged a tissue, as disclosed
herein;
[0092] FIG. 17B shows an embodiment of a portion of an apparatus
for engaging a tissue having an expanded skirt that has engaged a
tissue, as disclosed herein;
[0093] FIG. 18A shows an embodiment of a portion of an apparatus
for engaging a tissue having a collapsed skirt present within a
sleeve, as disclosed herein;
[0094] FIG. 18B shows an embodiment of a portion of an apparatus
for engaging a tissue having an expanded skirt, as disclosed
herein;
[0095] FIG. 19 shows an embodiment of a system for engaging a
tissue, as disclosed herein;
[0096] FIG. 20A shows an embodiment of a portion of an apparatus
for engaging a tissue having a lead positioned therethrough, as
disclosed herein;
[0097] FIG. 20B shows an embodiment of a portion of an apparatus
for engaging a tissue showing a needle, as disclosed herein;
[0098] FIG. 20C shows the embodiment of FIG. 20B having a lead
positioned therethrough,
[0099] FIG. 21A shows an embodiment of a portion of an apparatus
for removing fluid from a tissue, as disclosed herein;
[0100] FIG. 21B shows an embodiment of a portion of an apparatus
comprising grooves for removing fluid from a tissue, as disclosed
herein;
[0101] FIG. 22 shows an embodiment of a portion of an apparatus for
removing fluid from a tissue inserted within a heart, as disclosed
herein;
[0102] FIG. 23A shows an embodiment of a catheter system with a
deflated balloon, as disclosed herein;
[0103] FIG. 23B shows an embodiment of a catheter system with an
inflated balloon, as disclosed herein;
[0104] FIG. 24 shows an embodiment of a catheter system positioned
within the pericardial space surrounding a heart, as disclosed
herein;
[0105] FIG. 25A shows an embodiment of a portion of a
suction/infusion catheter, apparatus as disclosed herein;
[0106] FIG. 25B shows an embodiment of a portion of a
suction/infusion catheter comprising grooves, as disclosed
herein;
[0107] FIG. 26 shows an embodiment of a heart assist device with a
deflated bladder, as disclosed herein;
[0108] FIG. 27 shows an embodiment of a heart assist device with an
inflated bladder, as disclosed herein;
[0109] FIG. 28 shows a patient wearing an embodiment of a heart
assist device, as disclosed herein;
[0110] FIG. 29A shows an embodiment of a suction/infusion catheter
positioned within an inflated pericardial space, as disclosed
herein;
[0111] FIG. 29B shows an embodiment of a suction/infusion catheter
positioned within an inflated pericardial space, as disclosed
herein;
[0112] FIG. 30A shows an embodiment of a suction/infusion catheter
with a pericardial balloon coupled thereto, as disclosed
herein;
[0113] FIG. 30B shows the embodiment of FIG. 30A with an inflated
pericardial balloon;
[0114] FIG. 31A shows an embodiment of a suction/infusion catheter
positioned within a pericardial space surrounding a heart, as
disclosed herein;
[0115] FIG. 31B shows the embodiment of FIG. 31A with an inflated
pericardial balloon;
[0116] FIG. 32A shows an embodiment of a suction/infusion catheter
with a pericardial balloon positioned within a pericardial space at
or near the left ventricle of a heart, as disclosed herein; and
[0117] FIG. 32B shows an embodiment of a device/apparatus of the
present disclosure comprising multiple suction/infusion catheters
with pericardial balloons present within a pericardial space
surrounding a heart, as disclosed herein.
DETAILED DESCRIPTION
[0118] 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.
[0119] The disclosed embodiments include devices, systems, and
methods useful for accessing various tissues of the heart from
inside the heart and is directed to devices, systems, and methods
for treating patients with congestive heart failure (CHF),
including those patients with a different functional class of CHF.
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. Systems
and devices of the present disclosure are considered as a support
for the native heart contraction and as a non-blood contact system
or device. Suction (to enhance myocardial perfusion in diastole)
and compression (to assist and unload the heart in systole) in the
pericardial space are synchronized with the cardiac cycle in
accordance with the devices, systems, and methods of the present
disclosure.
[0120] The devices, systems, and methods of the present disclosure
are characterized by the use of the pericardial sac (the space
between parietal pericardium and visceral pericardium) as a pump
bladder. The injection and suction of a noble gas through a
catheter of the present disclosure in to and out of the heart is
performed in a controlled manner by synchrony with the cardiac
cycle.
[0121] The present disclosure provides interesting new revelations
on how topically applied negative pressure may improve
microvascular blood flow in the myocardium. Studies have shown that
when myocardium was exposed to a topical negative pressure of -50
mm Hg, an immediate significant increase in microvascular blood
flow was observed. This is in accordance with previous results
showing increased microvascular blood flow of the skeletal muscle
upon application of TNP. Lindstedt S. et al. (2007). The devices,
systems, and methods of the present disclosure relate to such an
improvement in blood flow by novel and beneficial means as
described herein.
[0122] 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).
[0123] 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.
[0124] In the embodiment of the catheter system shown in FIG. 1A,
catheter system 10 includes an engagement catheter 20, a delivery
catheter 30, and a needle 40. Although each of engagement catheter
20, delivery catheter 30, and needle 40 has a proximal end and a
distal end, FIG. 1A shows only the distal end. Engagement catheter
20 has a lumen through which delivery catheter 30 has been
inserted, and delivery catheter 30 has a lumen through which needle
40 has been inserted. Delivery catheter 30 also has a number of
openings 50 that can be used to transmit fluid from the lumen of
the catheter to the heart tissue in close proximity to the distal
end of the catheter.
[0125] As shown in more detail in FIGS. 2A, 2B, 2C, engagement
catheter 20 includes a vacuum channel 60 used for suction of a
targeted tissue 65 in the heart and an injection channel 70 used
for infusion of substances to targeted tissue 65, including, for
example, a biological or non-biological degradable adhesive. As is
shown in FIGS. 2B and 2C, injection channel 70 is ring-shaped,
which tends to provide relatively even dispersal of the infused
substance over the targeted tissue, but other shapes of injection
channels may be suitable. A syringe 80 is attached to injection
channel 70 for delivery of the appropriate substances to injection
channel 70, and a syringe 90 is attached to vacuum channel 60
through a vacuum port (not shown) at the proximal end of engagement
catheter 20 to provide appropriate suction through vacuum channel
60. At the distal end of engagement catheter 20, a suction port 95
is attached to vacuum channel 60 for contacting targeted tissue 65,
such that suction port 95 surrounds targeted tissue 65, which is
thereby encompassed within the circumference of suction port 95.
Although syringe 90 is shown in FIG. 2B as the vacuum source
providing suction for engagement catheter 20, other types of vacuum
sources may be used, such as a controlled vacuum system providing
specific suction pressures. Similarly, syringe 80 serves as the
external fluid source in the embodiment shown in FIG. 2B, but other
external fluid sources may be used.
[0126] 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).
[0127] Referring now to FIG. 1B, an engagement catheter 100 is
placed via standard approach into the jugular or femoral vein. The
catheter, which may be 4 or 5 Fr., is positioned under fluoroscopic
or echocardiographic guidance into the right atrial appendage 110.
Suction is initiated to aspirate a portion of atrial appendage 110
away from the pericardial sac 120 that surrounds the heart. As
explained herein, aspiration of the heart tissue is evidenced when
no blood can be pulled back through engagement catheter 100 and, if
suction pressure is being measured, when the suction pressure
gradually increases. A delivery catheter 130 is then inserted
through a lumen of engagement catheter 100. A small perforation can
be made in the aspirated atrial appendage 110 with a needle such as
needle 40, as shown in FIGS. 1A and 2A. A guide wire (not shown)
can then be advanced through delivery catheter 130 into the
pericardial space to secure the point of entry 125 through the
atrial appendage and guide further insertion of delivery catheter
130 or another catheter. Flouroscopy or echocardiogram can be used
to confirm the position of the catheter in the pericardial space.
Alternatively, a pressure tip needle can sense the pressure and
measure the pressure change from the atrium (about 10 mmHg) to the
pericardial space (about 2 mmHg). This is particularly helpful for
transeptal access where puncture of arterial structures (e.g., the
aorta) can be diagnosed and sealed with an adhesive, as described
in more detail below.
[0128] 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.
[0129] Referring now to FIG. 3A, the catheter system shown in FIG.
1B is retrieved by pull back through the route of entry. However,
the puncture of the targeted tissue in the heart (e.g., the right
atrial appendage as shown in FIG. 3A) may be sealed upon withdrawal
of the catheter, which prevents bleeding into the pericardial
space. The retrieval of the catheter may be combined with a sealing
of the tissue in one of several ways: (1) release of a tissue
adhesive or polymer 75 via injection channel 70 to seal off the
puncture hole, as shown in FIG. 3B; (2) release of an inner clip or
mechanical stitch to close off the hole from the inside of the
cavity or the heart, as discussed herein; or (3) mechanical closure
of the heart with a sandwich type mechanical device that approaches
the hole from both sides of the wall (see FIGS. 4A, 4B, and 4C). In
other words, closure may be accomplished by using, for example, a
biodegradable adhesive material (e.g., fibrin glue or
cyanomethacrylate), a magnetic system, or an umbrella-shaped
nitinol stent. An example of the closure of a hole in the atrium is
shown in FIG. 3B. Engagement catheter 20 is attached to targeted
tissue 95 using suction through suction port 60. Tissue adhesive 75
is injected through injection channel 70 to coat and seal the
puncture wound in targeted tissue 95. Engagement catheter 20 is
then withdrawn, leaving a plug of tissue adhesive 75 attached to
the atrial wall or atrial appendage.
[0130] Other examples for sealing the puncture wound in the atrial
wall or appendage are shown in FIGS. 4A-4F. Referring now to FIGS.
4A-4C, a sandwich-type closure member, having an external cover 610
and an internal cover 620, is inserted through the lumen of
engagement catheter 600, which is attached to the targeted tissue
of an atrial wall 630. Each of external and internal covers 610 and
620 is similar to an umbrella in that it can be inserted through a
catheter in its folded configuration and expanded to an expanded
configuration once it is outside of the catheter. As shown in FIG.
4A, external cover 610 is deployed (in its expanded configuration)
on the outside of the atrial wall to seal a puncture wound in the
targeted tissue, having already been delivered through the puncture
wound into the pericardial space. Internal cover 620 is delivered
through engagement catheter 600 (in its folded configuration), as
shown in FIGS. 4A and 4B, by an elongated delivery wire 615, to
which internal cover 620 is reversibly attached (for example, by a
screw-like mechanism). Once internal cover 620 is in position on
the inside of atrial wall 630 at the targeted tissue, internal
cover 620 is deployed to help seal the puncture wound in the
targeted tissue (see FIG. 4C).
[0131] 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.
[0132] 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 FIG. 4C. External cover 610 and internal cover 620 may be
held in place using a biocompatible adhesive. Similarly, external
cover 610 and internal cover 620 may be held in place using
magnetic forces, such as, for example, by the inside face (not
shown) of external cover 610 comprising a magnet, by the inside
face (not shown) of internal cover 620 comprising a magnet, or both
inside faces of external cover 610 or internal cover 620 comprising
magnets.
[0133] In the embodiment shown in FIGS. 4A, 4B, and 4C, the closure
member comprises external cover 610 and internal cover 620.
However, in at least certain other embodiments, the closure member
need not have two covers. For example, as shown in FIG. 4D, closure
member 632 is made of only one cover 634. Cover 634 has a first
face 636 and a second face 638, and first face 636 is configured
for reversible attachment to distal end 642 of delivery wire 640.
Closure member 632 may be made of any suitable material, including
nitinol, which is capable of transitioning from a folded
configuration to an expanded configuration.
[0134] In the embodiment shown in FIG. 4E, a closure member 1500
comprises an external cover 1510 and an internal cover 1520 within
a delivery catheter 1530. External cover 1510 and internal cover
1520 are attached at a joint 1540, which may be formed, for
example, by a mechanical attachment or by a magnetic attachment. In
embodiments having a magnetic attachment, each of the external
cover and the internal cover may have a ferromagnetic component
that is capable of magnetically engaging the other ferromagnetic
component.
[0135] 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.
[0136] 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.
[0137] FIG. 4F shows the occlusion of a hole (not shown) in atrial
wall 1600 due to the sandwiching of atrial wall 1600 between an
external cover 1610 and an internal cover 1620. External cover 1610
is shown deployed on the outside surface of atrial wall 1600, while
internal cover 1620 is deployed on the inside surface of atrial
wall 1600. As shown, rod 1640 is engaged with internal cover 1620,
and delivery catheter 1630 is in the process of being withdrawn,
which allows internal cover 1620 to fully deploy. Rod 1640 is then
withdrawn through delivery catheter 1630. An engagement catheter
(not shown) may surround delivery catheter 1650, as explained more
fully herein.
[0138] Other examples for sealing a puncture wound in the cardiac
tissue are shown in FIGS. 12-15. Referring now to FIG. 12A, there
is shown a plug 650 having a first end 652, a second end 654, and a
hole 656 extending from first end 652 to second end 654. Plug 650
may be made from any suitable material, including casein,
polyurethane, silicone, and polytetrafluoroethylene. Wire 660 has
been slidably inserted into hole 656 of plug 650. Wire 660 may be,
for example, a guide wire or a pacing lead, so long as it extends
through the hole in the cardiac tissue (not shown). As shown in
FIG. 12A, first end 652 is covered with a radiopaque material, such
as barium sulfate, and is therefore radiopaque. This enables the
clinician to view the placement of the plug in the body using
radiographic imaging. For example, the clinician can confirm the
location of the plug during the procedure, enabling a safer and
more effective procedure for the patient.
[0139] As shown in FIG. 12A, first end 652 of plug 650 has a
smaller diameter than second end 654 of plug 650. Indeed, plug 680
shown FIG. 12B and plug 684 shown in FIGS. 13 and 14 have first
ends that are smaller in diameter than their respective second
ends. However, not all embodiments of plug have a first end that is
smaller in diameter than the second end. For example, plug 682
shown in FIG. 12C has a first end with a diameter that is not
smaller than the diameter of the second end. Both types of plug can
be used to close holes in cardiac tissue.
[0140] Referring again to FIG. 12A, elongated shaft 670 has a
proximal end (not shown), a distal end 672, and a lumen 674
extending from the proximal end to distal end 672. Although no
catheter is shown in FIG. 12A, plug 650, wire 660, and shaft 670
are configured for insertion into a lumen of a catheter (see FIG.
14), such as an embodiment of an engagement catheter disclosed
herein. Plug 650 and shaft 670 are also configured to be inserted
over wire 660 and can slide along wire 660 because each of lumen
656 of plug 650 and lumen 674 of shaft 670 is slightly larger in
circumference than wire 660.
[0141] As shown in FIGS. 13 and 14, shaft 672 is used to push plug
684 along wire 674 within elongated tube 676 to and into the hole
in the targeted cardiac tissue 678. Distal end 677 of elongated
tube 676 is shown attached to cardiac tissue 678, but distal end
677 need not be attached to cardiac tissue 678 so long as distal
end 677 is adjacent to cardiac tissue 678. Once plug 684 is
inserted into the hole, wire 674 may be withdrawn from the hole in
plug 684 and the interior of the heart (not shown) and shaft 672 is
withdrawn from elongated tube 676. In some embodiments; the plug is
self-sealing, meaning that the hole of the plug closes after the
wire is withdrawn. For example; the plug may be made from a
dehydrated protein matrix, such as casein or ameroid, which swells
after soaking up fluid. After shaft 672 is withdrawn, elongated
tube 676 can be withdrawn from the heart.
[0142] 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.
[0143] Referring now to FIG. 12B, there is shown a plug 680 that is
similar to plug 684. However, plug 680 comprises external surface
681 having a ridge 683 that surrounds plug 680 in a helical or
screw-like shape. Ridge 683 helps to anchor plug 680 into the hole
of the targeted tissue (not shown). Other embodiments of plug may
include an external surface having a multiplicity of ridges
surrounding the plug, for example, in a circular fashion.
[0144] FIGS. 15A-15C show yet another embodiment of a closure
member for closing a hole in a tissue. Spider clip 1700 is shown
within catheter 1702 and comprises a head 1705 and a plurality of
arms 1710, 1720, 1730, and 1740. Each of arms 1710, 1720, 1730, and
1740 is attached at its proximal end to head 1705. Although spider
clip 1700 has four arms, other embodiments of spider clip include
fewer than, or more than, four arms. For example, some embodiments
of spider clip have three arms, while others have five or more
arms.
[0145] Referring again to FIGS. 15A-15C, arms 1710, 1720, 1730, and
1740 may be made from any flexible biocompatible metal that can
transition between two shapes, such as a shape-memory alloy (e.g.,
nitinol) or stainless steel. Spider clip 1700 is capable of
transitioning between an open position (see FIG. 15A), in which the
distal ends of its arms 1710, 1720, 1730, and 1740 are spaced
apart, and a closed position (see FIG. 15C), in which the distal
ends of arms 1710, 1720, 1730, and 1740 are gathered together. For
embodiments made from a shape-memory alloy, the clip can be
configured to transition from the open position to the closed
position when the metal is warmed to approximately body
temperature, such as when the clip is placed into the cardiac
tissue. For embodiments made from other types of metal, such as
stainless steel, the clip is configured in its closed position, but
may be transitioned into an open position when pressure is exerted
on the head of the clip. Such pressure causes the arms to bulge
outward, thereby causing the distal ends of the arms to
separate.
[0146] 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, FIG. 15B shows spider clip 1700 engaged by rod 1750 within
engagement catheter 1760. As shown, engagement catheter 1760 has a
bell-shaped suction port 1765, which, as disclosed herein, has
aspirated cardiac tissue 1770. Cardiac tissue 1770 includes a hole
1775 therethrough, and suction port 1765 fits over hole 1775 so as
to expose hole 1775 to spider clip 1700.
[0147] 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.
[0148] 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.
[0149] Referring to FIG. 15C, spider clip 1700 approaches cardiac
tissue 1770 and eventually engages cardiac tissue 1770 such that
the distal end of each of arms 1710, 1720, 1730, and 1740 contacts
cardiac tissue 1770. Rod 1750 is disengaged from spider clip 1700,
and spider clip 1700 transitions to its closed position, thereby
drawing the distal ends of arms 1710, 1720, 1730, and 1740
together. As the distal ends of the arms are drawn together, the
distal ends grip portions of cardiac tissue 1770, thereby
collapsing the tissue between arms 1710, 1720, 1730, and 1740 such
that hole 1775 is effectively closed.
[0150] 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.
[0151] FIG. 15D shows an exemplary embodiment of a system for
closing an aperture in a tissue according to the present
disclosure. As shown in FIG. 15D, system 3800 comprises a catheter
3802, including, but no limited to, an engagement, delivery, and/or
suction/infusion catheter as described herein, and further
comprises a coil 3804 and a shaft 3806 positioned within an
internal lumen of catheter 3802. In the exemplary embodiment shown
in FIG. 15D, an optional guide wire 3808 may be used to facilitate
the positioning of catheter 3802 to an atrial wall 3810. In at
least one embodiment, catheter 3802 comprises an engagement
catheter, wherein the engagement catheter has engaged an atrial
wall 3810, and wherein an aperture within atrial wall 3810 allows,
for example, a guide wire 3808, a delivery catheter, a
suction/infusion catheter, and/or another device or apparatus to
enter the aperture within the atrial wall 3810.
[0152] In at least one embodiment, coil 3804 is substantially
straight when it is introduced within a lumen of a catheter 3802.
In another embodiment, coil 3804 is somewhat, but not fully, coiled
as it is introduced within the lumen of catheter 3800. In at least
one embodiment, coil 3804 comprises a "memory," wherein the memory
comprises a first configuration. In an exemplary embodiment, the
first configuration is an uncompressed configuration. In another
embodiment, the memory further comprises a second configuration,
and in at least one embodiment, the second configuration is a
compressed configuration. In at least one embodiment, coil 3804 is
fluoroscopic so that a user of coil 3804 may use, for example,
x-ray technology, to assist with placement of coil 3804 within a
body.
[0153] In the exemplary embodiment shown in FIG. 15D, coil 3804 is
positioned within the lumen of catheter 3802, and as coil 3804 is
introduced at or near the atrial wall 3810, a portion of coil 3804
is positioned within an aperture within atrial wall 3810. When
positioned, coil 3804 may be compressed using, for example, shaft
3806, whereby shaft 3806 exerts pressure upon coil 3804, causing
coil 3804 to compress at or near the aperture within atrial wall
3810. In the embodiment shown in FIG. 15E, shaft 3806 has exerted
pressure upon coil 3804, causing coil 3804 to compress on both
sides of atrial wall 3810 (with part of coil 3804 positioned within
a pericardial sac and part of the coil positioned within an atrial
cavity). This compression may then facilitate closure of an
aperture within atrial wall 3810, as portions of coil 3804, when
compressed as shown in FIG. 15E, may exert pressure on one or both
sides of atrial wall 3810, wherein the aperture within atrial wall
3810 may either be partially or fully occluded by coil 3804. FIG.
15F shows an exemplary embodiment of a coil 3804 in a compressed
formation.
[0154] It can be appreciated that pressure exerted upon coil 3804
by shaft 3806 may also facilitate placement of coil 3804 at or near
an aperture within atrial wall 3810. In at least one embodiment,
coil 3804 may be "screwed" into an aperture within atrial wall
3810, using shaft 3806 and/or by physically turning coil 3804 as it
is positioned within atrial wall 3810. In addition, and in at least
one embodiment, guide wire 3808 may facilitate placement of coil
3804 within an aperture of atrial wall 3810.
[0155] Any number of materials may be used to form coil 3804,
including, but not limited to, nitinol and/or stainless steel. In
addition, coil 3804 may be coated with one or more materials,
including, but not limited to, polytetrafluoroethylene (PTFE),
polyethylene terephthalate (Dacron, for example), and/or
polyurethane. In addition, one or more other materials, including,
but not limited to, materials known in the art to facilitate blood
coagulation, including, but not limited to, cotton fibers, may be
coupled to coil 3804 to facilitate aperture occlusion.
[0156] FIGS. 16A, 16B, and 16C show an embodiment of a portion of
an apparatus for engaging a tissue as disclosed herein. As shown in
FIG. 16A, a sleeve 1800 is present around at least a portion of an
engagement catheter 1810. Sleeve 1800, as described herein, may
comprise a rigid or flexible tube having a lumen therethrough,
appearing around the outside of engagement catheter 1810 and
slidingly engaging engagement catheter 1810. In at least the
embodiment shown in FIG. 16A, the distal end 1820 of engagement
catheter 1810 comprises a skirt 1830, shown in FIG. 16A as being
housed within sleeve 1800. A delivery catheter 1840 may be present
within engagement catheter 1810 as shown to facilitate the delivery
of a product (gas, liquid, and/or particulate(s)) to a target site.
In this embodiment, delivery catheter 1840 is present at least
partially within the lumen of engagement catheter 1810, and
engagement catheter is placed at least partially within the lumen
of sleeve 1800.
[0157] Referring now to FIG. 16B, an embodiment of an apparatus as
shown in FIG. 16A or similar to the embodiment shown in FIG. 16A is
shown with sleeve 1800 being "pulled back" from the distal end of
engagement catheter 1810. As shown in FIG. 16B, as sleeve 1800 is
pulled back (in the direction of the arrow), skirt 1830 becomes
exposed, and as sleeve 1800 is no longer present around skirt 1830,
skirt 1830 may optionally expand into a frusto-conical
("bell-shaped") skirt 1830. Skirt 1830 may be reversibly deformed
(collapsed) when present within the lumen of sleeve 1800 as shown
in FIG. 16A and in FIG. 18A described in further detail herein. It
can be appreciated that many alternative configurations of skirt
1830 to the frusto-conical configuration may exist, including an
irregular frusto-conical configuration, noting that a configuration
of skirt 1830 having a distal portion (closest to a tissue to be
engaged) larger than a proximal position may benefit from suction
of a larger surface area of a tissue as described in further detail
herein.
[0158] FIG. 16C shows an embodiment of an apparatus described
herein having an expanded skirt 1830. As shown in FIG. 16C, sleeve
1800 has been pulled back (in the direction of the arrow) so that
the expanded configuration of skirt 1830 may be present to engage a
tissue (not shown).
[0159] FIGS. 17A and 17B shown alternative embodiments of a portion
of an apparatus for engaging a tissue as described herein. FIGS.
17A and 17B each show a sleeve 1800, an engagement catheter 1810
having a skirt 1830, and a delivery catheter 1840. In each figure,
skirt 1830 is shown engaging a surface of a tissue 1850. In the
embodiments shown in FIGS. 17A and 17B, the relative sizes of the
sleeves 1800, engagement catheters 1810, and delivery catheters
1840 are similar as shown, but the relative sizes of the skirts
1830 of the engagement catheters 1810 are clearly different. The
exemplary embodiment of the portion of an apparatus for engaging a
tissue shown in FIG. 17A comprises a skirt 1830 of the same or
substantially similar relative size as the engagement catheter
1810, meaning that the diameters of the engagement catheter 1810
and the skirt 1830 shown in FIG. 17A are approximately the same.
Conversely, the exemplary embodiment of the portion of an apparatus
for engaging a tissue shown in FIG. 17B comprises a skirt 1830
notably larger than the engagement catheter 1810, meaning that the
diameters of the engagement catheter 1810 and the skirt 1830 at its
widest point shown in FIG. 17B are notably different. As shown in
FIG. 17B, as skirt 1830 extends from engagement catheter 1810 to
tissue 1850, the diameter of skirt 1830 increases. As such, skirt
1830 of the embodiment shown in FIG. 17B may engage a larger
surface area of a tissue (shown by 1860) than the embodiment of the
skirt 1830 shown in FIG. 17A. The ability to engage a larger
surface area of a tissue 1850 by skirt 1830 allows a better
reversible engagement of a tissue 1850 when a vacuum is provided as
described in detail herein. This improved suction allows a person
using such an apparatus to more effectively engage a tissue 1850
than would otherwise be possible when skirt 1830 engages a smaller
surface area of a tissue.
[0160] FIGS. 18A and 18B show perspective views of an embodiment of
a portion of an apparatus for engaging a tissue. FIG. 18A
represents an embodiment whereby a skirt 1830 of an engagement
catheter 1810 is positioned substantially within a sleeve 1800.
FIG. 18B represents an embodiment whereby a skirt 1830 of an
engagement catheter 1810 is positioned outside of s 1800. As such,
the positioning of skirt 1830 within sleeve 1800 can be seen in the
embodiments of FIGS. 16A and 18A, and the positioning of skirt 1830
outside of sleeve 1800 can be seen in the embodiments of FIGS. 16C
and 18B.
[0161] As shown in FIG. 18A, skirt 1830 of engagement catheter 1810
is positioned within sleeve 1800, whereby the configuration of
skirt 1830 is collapsed so that skirt 1830 may fit within sleeve
1800. As sleeve 1800 moves in the direction of the arrow shown in
FIG. 18B, skirt 1830 becomes exposed and its configuration is
allowed to expand because there are no constraints provided by the
inner wall of sleeve 1800.
[0162] The embodiments shown in FIGS. 18A and 18B also show an
exemplary embodiment of a configuration of an engagement catheter
1810. As shown in FIG. 18B, engagement catheter 1810 defines a
number of apertures (representing lumens) present at the distal end
of engagement catheter 1810 (at the proximal end of skirt 1830),
including, but not limited to, one or more vacuum ports 1870
(representing the aperture at or near the distal end of a vacuum
tube), and a delivery port 1880 (representing the aperture at or
near the distal end of a delivery tube). A vacuum source (not
shown) may be coupled to a suction port located at a proximal end
of one or more vacuum tubes as described herein, whereby gas,
fluid, and/or particulate(s) may be introduced into one or more
vacuum ports 1870 by the introduction of a vacuum at a vacuum port.
Gas, fluid, and/or particulate(s) may be introduced from delivery
aperture 1880 to a tissue (not shown in FIGS. 18A or 18B).
[0163] As shown by the exemplary embodiments of FIGS. 17A and 17B,
the ability for a user of such an apparatus for engaging a tissue
to obtain proper suction depends at least in part on the relative
placement of skirt 1830 and delivery catheter 1840 at or near a
tissue 1850. As described in detail herein regarding the exemplary
embodiment shown in FIG. 5D, if a vacuum source provides suction
through one or more vacuum ports 1870 (shown in FIGS. 18A and 18B),
but skirt 1830 has not effectively engaged a tissue 1850, gas,
fluid, and/or particulate(s) in the area of tissue 1850 and/or gas,
fluid and/or particulate(s) delivered via delivery catheter 1840 to
the area of tissue 1850 may be aspirated by one or more vacuum
ports 1870. In a situation where skirt 1830 has effectively engaged
a tissue 1850 but where delivery catheter 1840 has not engaged a
tissue 1850, any gas, liquid, and/or particulate(s) delivered by
delivery catheter 1840 may be aspirated by one or more vacuum ports
1870. In a situation where skirt 1830 and delivery catheter 1840
have effectively engaged a tissue 1850, most, if not all, of any
gas, liquid, and/or particulate(s) delivered by delivery catheter
1840 to tissue 1850 would not be aspirated by one or more vacuum
ports 1870 as the placement of delivery catheter 1840 on or within
tissue 1850 would provide direct delivery at or within tissue
1850.
[0164] An exemplary embodiment of a system and/or device for
engaging a tissue as described herein is shown in FIG. 19. As shown
in FIG. 19, an exemplary apparatus shows a sleeve 1800 which has
been moved in the direction of the arrow to reveal skirt 1830 at
the distal end of engagement catheter 1810, allowing skirt to
resume an expanded, frusto-conical configuration. As shown in this
embodiment, delivery catheter 1840 has been introduced at the
proximal end of the apparatus (in the direction shown by the dashed
arrow), allowing delivery catheter 1840 to exit out of a delivery
lumen (not shown) at the distal end of engagement catheter 1840. A
needle 1890 may be present at the distal end of delivery catheter
1840, facilitating the potential puncture of a tissue (not shown)
to allow the distal end of delivery catheter 1840 to enter a
tissue.
[0165] In addition, and as shown in the exemplary embodiment of
FIG. 19, a lead 1900 may be introduced into delivery catheter 1840
(in the direction shown by the dashed arrow), whereby the distal
end of lead 1900 may exit an aperture of needle 1890 and optionally
enter a tissue and/or a lumen of a tissue. As described herein, any
number of suitable types of leads 1900 may be used with the
delivery catheters described herein, including sensing leads and/or
pacing leads. A vacuum source 1910 may also provide a source of
vacuum to such an apparatus to allow skirt 1830 to engage a tissue
using suction,
[0166] The exemplary embodiment of an apparatus for engaging a
tissue as shown in FIG. 19 comprises an engagement catheter 1810
having a curvature. Such a curved engagement catheter 1810 allows a
user of such an apparatus, for example, to insert a portion of the
apparatus into a body or tissue from one direction, and engage a
tissue with skirt 1830, delivery catheter 1840, needle 1890, and/or
lead 1900 from another direction. For example, a user may introduce
a portion of an apparatus from one side of the heart, and the
apparatus may engage the heart from a different direction than the
direction of introduction of the apparatus.
[0167] 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.
[0168] Referring now to FIGS. 20A, 20B, and 20C, embodiments of a
portion of an apparatus for engaging a tissue according to the
present disclosure are shown. As shown in FIG. 20A, an exemplary
embodiment of a portion of an apparatus for engaging a tissue
comprises sleeve 1800 slidingly engaging engagement catheter 1810,
and when sleeve 1800 is slid in the direction of the arrow shown,
skirt 1830 is revealed, having an expanded, optionally
frusto-conical configuration as shown. Delivery catheter 1840 may
exit out of a delivery lumen (not shown), with needle 1890 present
at the distal end of delivery catheter 1840. As shown in the
embodiment of FIG. 20A, lead 1900 is present, exiting out of an
aperture of needle 1890.
[0169] FIGS. 20B and 20C show a closer view of an embodiment of a
portion of an apparatus for engaging a tissue according to the
present disclosure than is shown in FIG. 20A. As shown in FIGS. 20B
and 20C, aperture 1920 of needle 1890 is shown, and as shown in
FIG. 20C, lead 1900 may exit aperture 1920 of needle 1890.
[0170] Referring now to FIGS. 5A, 5B, 5C, and 5D, there is shown
another embodiment of an engagement catheter as disclosed herein.
Engagement catheter 700 is an elongated tube having a proximal end
710 and a distal end 720, as well as two lumens 730, 740 extending
between proximal end 710 and distal end 720. Lumens 730, 740 are
formed by concentric inner wall 750 and outer wall 760, as
particularly shown in FIGS. 5B and 5C. At proximal end 710,
engagement catheter 700 includes a vacuum port 770, which is
attached to lumen 730 so that a vacuum source can be attached to
vacuum port 770 to create suction in lumen 730, thereby forming a
suction channel. At distal end 720 of catheter 700, a suction port
780 is attached to lumen 730 so that suction port 780 can be placed
in contact with heart tissue 775 (see FIG. 5D) for aspirating the
tissue, thereby forming a vacuum seal between suction port 780 and
tissue 775 when the vacuum source is attached and engaged. The
vacuum seal enables suction port 780 to grip, stabilize, and
retract tissue 775. For example, attaching a suction port to an
interior atrial wall using a vacuum source enables the suction port
to retract the atrial wall from the pericardial sac surrounding the
heart, which enlarges the pericardial space between the atrial wall
and the pericardial sac.
[0171] As shown in FIG. 5C, two internal lumen supports 810, 820
are located within lumen 730 and are attached to inner wall 750 and
outer wall 760 to provide support to the walls. These lumen
supports divide lumen 730 into two suction channels. Although
internal lumen supports 810, 820 extend from distal end 720 of
catheter 700 along a substantial portion of the length of catheter
700, internal lumen supports 810, 820 may or may not span the
entire length of catheter 700. Indeed, as shown in FIGS. 5A, 5B,
and 5C, internal lumen supports 810, 820 do not extend to proximal
end 710 to ensure that the suction from the external vacuum source
is distributed relatively evenly around the circumference of
catheter 700. Although the embodiment shown in FIG. 5C includes two
internal lumen supports, other embodiments may have just one
internal support or even three or more such supports.
[0172] FIG. 5D shows engagement catheter 700 approaching heart
tissue 775 for attachment thereto. It is important for the
clinician performing the procedure to know when the suction port
has engaged the tissue of the atrial wall or the atrial appendage.
For example, in reference to FIG. 5D, it is clear that suction port
780 has not fully engaged tissue 775 such that a seal is formed.
However, because suction port 780 is not usually seen during the
procedure, the clinician may determine when the proper vacuum seal
between the atrial tissue and the suction port has been made by
monitoring the amount of blood that is aspirated, by monitoring the
suction pressure with a pressure sensor/regulator, or both. For
example, as engagement catheter 700 approaches the atrial wall
tissue (such as tissue 775) and is approximately in position, the
suction can be activated through lumen 730. A certain level of
suction (e.g., 10 mmHg) can be imposed and measured with a pressure
sensor/regulator. As long as catheter 700 does not engage the wall,
some blood will be aspirated into the catheter and the suction
pressure will remain the same. However, when catheter 700 engages
or attaches to the wall of the heart (depicted as tissue 775 in
FIG. 5D), minimal blood is aspirated and the suction pressure will
start to gradually increase. Each of these signs can alert the
clinician (through alarm or other means) as an indication of
engagement. The pressure regulator is then able to maintain the
suction pressure at a preset value to prevent over-suction of the
tissue.
[0173] 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 FIGS. 5A and 5C
includes an injection channel 790 at distal end 720. Injection
channel 790 dispenses to the targeted tissue a substance flowing
through lumen 740. As shown in FIG. 5D, injection channel 790 is
the distal end of lumen 740. However, in other embodiments, the
injection channel may be ring-shaped (see FIG. 2C) or have some
other suitable configuration.
[0174] 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.
[0175] Referring now to FIGS. 6A, 6B, and 6C, there is shown a
delivery catheter 850 comprising an elongated hollow tube 880
having a proximal end 860, a distal end 870, and a lumen 885 along
the length of the catheter. Extending from distal end 870 is a
hollow needle 890 in communication with lumen 885. Needle 890 is
attached to distal end 870 in the embodiment of FIGS. 6A, 6B, and
6C, but, in other embodiments, the needle may be removably attached
to, or otherwise located at, the distal end of the catheter (see
FIG. 1A). In the embodiment shown in FIGS. 6A, 6B, and 6C, as in
certain other embodiments having an attached needle, the junction
(i.e., site of attachment) between hollow tube 880 and needle 890
forms a security notch 910 circumferentially around needle 890 to
prevent needle 890 from over-perforation. Thus, when a clinician
inserts needle 890 through an atrial wall to gain access to the
pericardial space, the clinician will not, under normal conditions,
unintentionally perforate the pericardial sac with needle 890
because the larger diameter of hollow tube 880 (as compared to that
of needle 890) at security notch 910 hinders further needle
insertion. Although security notch 910 is formed by the junction of
hollow tube 880 and needle 890 in the embodiment shown in FIGS. 6A,
6B, and 6C, other embodiments may have a security notch that is
configured differently. For example, a security notch may include a
band, ring, or similar device that is attached to the needle a
suitable distance from the tip of the needle. Like security notch
910, other security notch embodiments hinder insertion of the
needle past the notch itself by presenting a larger profile than
the profile of the needle such that the notch does not easily enter
the hole in the tissue caused by entry of the needle.
[0176] 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.
[0177] Alternatively, as shown in FIG. 6B, needle 890 may be
connected to a strain gauge 915 as part of the catheter assembly.
When needle 890 contacts tissue (not shown), needle 890 will be
deformed. The deformation will be transmitted to strain gauge 915
and an electrical signal will reflect the deformation (through a
classical wheatstone bridge), thereby alerting the clinician. Such
confirmation of the puncture of the wall can prevent over-puncture
and can provide additional control of the procedure.
[0178] In some embodiments, a delivery catheter, such as catheter
850 shown in FIGS. 6A, 6B, and 6C, is used with an engagement
catheter, such as catheter 700 shown in FIGS. 5A, 5B, 5C, and 5D,
to gain access to the pericardial space between the heart wall and
the pericardial sac. For example, engagement catheter 700 may be
inserted into the vascular system and advanced such that the distal
end of the engagement catheter is within the atrium. The engagement
catheter may be attached to the targeted tissue on the interior of
a wall of the atrium using a suction port as disclosed herein. A
standard guide wire may be inserted through the lumen of the
delivery catheter as the delivery catheter is inserted through the
inner lumen of the engagement catheter, such as lumen 740 shown in
FIGS. 5B and 5C. Use of the guide wire enables more effective
navigation of the delivery catheter 850 and prevents the needle 890
from damaging the inner wall 750 of the engagement catheter 700.
When the tip of the delivery catheter with the protruding guide
wire reaches the atrium, the wire is pulled back, and the needle is
pushed forward to perforate the targeted tissue. The guide wire is
then advanced through the perforation into the pericardial space,
providing access to the pericardial space through the atrial
wall.
[0179] Referring again to FIGS. 6A, 6B, and 6C, lumen 885 of
delivery catheter 850 may be used for delivering fluid into the
pericardial space after needle 890 is inserted through the atrial
wall or the atrial appendage. After puncture of the wall or
appendage, a guide wire (not shown) may be inserted through needle
lumen 900 into the pericardial space to maintain access through the
atrial wall or appendage. Fluid may then be introduced to the
pericardial space in a number of ways. For example, after the
needle punctures the atrial wall or appendage, the needle is
generally withdrawn. If the needle is permanently attached to the
delivery catheter, as in the embodiment shown in FIGS. 6A and 6B,
then delivery catheter 850 would be withdrawn and another delivery
catheter (without an attached needle) would be introduced over the
guide wire into the pericardial space. Fluid may then be introduced
into the pericardial space through the lumen of the second delivery
catheter.
[0180] 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
FIG. 1A). In such embodiments, the needle is withdrawn through the
lumen of the delivery catheter, and the delivery catheter may be
inserted over the guide wire into the pericardial space. Fluid is
then introduced into the pericardial space through the lumen of the
delivery catheter.
[0181] 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.
[0182] Referring now to FIG. 7, there is shown a delivery catheter
1000. Delivery catheter 1000 includes an elongated tube 1010 having
a wall 1020 extending from a proximal end (not shown) of tube 1010
to a distal end 1025 of tube 1010. Tube 1010 includes two lumens,
but other embodiments of delivery catheters may have fewer than, or
more than, two lumens, depending on the intended use of the
delivery catheter. Tube 1010 also includes a steering channel 1030,
in which a portion of steering wire system 1040 is located.
Steering channel 1030 forms orifice 1044 at distal end 1025 of tube
1010 and is sized to fit over a guide wire 1050.
[0183] FIG. 8 shows in more detail steering wire system 1040 within
steering channel 1030 (which is shown cut away from the remainder
of the delivery catheter). Steering wire system 1040 is partially
located in steering channel 1030 and comprises two steering wires
1060 and 1070 and a controller 1080, which, in the embodiment shown
in FIG. 8, comprises a first handle 1090 and a second handle 1094.
First handle 1090 is attached to proximal end 1064 of steering wire
1060, and second handle 1094 is attached to proximal end 1074 of
steering wire 1070. Distal end 1066 of steering wire 1060 is
attached to the wall of the tube of the delivery catheter within
steering channel 1030 at attachment 1100, and distal end 1076 of
steering wire 1070 is attached to the wall of the tube of the
delivery catheter within steering channel 1030 at attachment 1110.
As shown in FIG. 7, attachment 1100 and attachment 1110 are located
on opposing sides of steering channel 1030 near distal tip 1120 of
delivery catheter 1000.
[0184] In the embodiment of FIG. 8, steering wires 1060 and 1070
are threaded as a group through steering channel 1030. However, the
steering wire systems of other embodiments may include steering
wires that are individually threaded through smaller lumens within
the steering channel. For example, FIG. 11 shows a cross-sectional
view of a delivery catheter 1260 having an elongated tube 1264
comprising a wall 1266, a steering channel 1290, a first lumen
1270, and a second lumen 1280. Delivery catheter 1260 further
includes a steering wire 1292 within a steering wire lumen 1293, a
steering wire 1294 within a steering wire lumen 1295, and a
steering wire 1296 within a steering wire lumen 1297. Each of
steering wire lumens 1293, 1295, and 1297 is located within
steering channel 1290 and is formed from wall 1266. Each of
steering wires 1292, 1294, and 1296 is attached to wall 1266 within
steering channel 1290. As will be explained, the attachment of each
steering wire to the wall may be located near the distal tip of the
delivery catheter, or may be located closer to the middle of the
delivery catheter.
[0185] Referring now to FIGS. 7 and 8, steering wire system 1040
can be used to control distal tip 1120 of delivery catheter 1000.
For example, when first handle 1090 is pulled, steering wire 1060
pulls distal tip 1120, which bends delivery catheter 1000, causing
tip deflection in a first direction. Similarly, when second handle
1094 is pulled, steering wire 1070 pulls distal tip 1120 in the
opposite direction, which bends delivery catheter 1000, causing tip
deflection in the opposite direction. Thus, delivery catheter 1000
can be directed (i.e., steered) through the body using steering
wire system 1040.
[0186] 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 FIG. 11), each of
which is attached to the steering channel at a different
attachment. Other embodiments of steering wire systems may have
four steering wires. Generally, more steering wires give the
clinician more control for directing the delivery catheter because
each additional steering wire enables the user to deflect the tip
of the delivery catheter in an additional direction. For example,
four steering wires could be used to direct the delivery catheter
in four different directions (e.g., up, down, right, and left).
[0187] 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 FIGS. 9A-9C, there is shown a steering wire system
1350 within steering channel 1360 (which is shown cut away from the
remainder of the delivery catheter) in different states of
deflection. Steering wire system 1350 is partially located in
steering channel 1360 and comprises three steering wires 1370,
1380, and 1390 and a controller 1400, which, in the embodiment
shown in FIGS. 9A-9C, comprises a handle 1405. Handle 1405 is
attached to proximal end 1374 of steering wire 1370, proximal end
1384 of steering wire 1380, and proximal end 1394 of steering wire
1390. Distal end 1376 of steering wire 1370 is attached to the wall
of the tube of the delivery catheter within steering channel 1360
at attachment 1378, which is near the distal tip of the delivery
catheter (not shown). Distal end 1386 of steering wire 1380 is
attached to the wall of the tube of the delivery catheter within
steering channel 1360 at attachment 1388, which is near the distal
tip of the delivery catheter (not shown). Attachment 1378 and
attachment 1388 are located on opposing sides of steering channel
1360 such that steering wires 1370 and 1380, when tightened (as
explained below), would tend to deflect the delivery catheter in
opposite directions. Distal end 1396 of steering wire 1390 is
attached to the wall of the tube of the delivery catheter within
steering channel 1360 at attachment 1398, which is located on the
delivery catheter at a point closer to the proximal end of the
delivery catheter than attachments 1378 and 1388. Attachment 1398
is located on the same side of steering channel 1360 as attachment
1388, such that steering wires 1380 and 1390, when tightened (as
explained below), would tend to deflect the delivery catheter in
the same direction. However, because attachment 1398 is closer to
the proximal end of the delivery catheter than is attachment 1388,
the tightening of steering wire 1390 tends to deflect the delivery
catheter at a point closer to the proximal end of the delivery
catheter than does the tightening of steering wire 1380. Thus, as
shown in FIG. 9A, the tightening of steering wire 1390 causes a
deflection in the delivery catheter approximately at point 1410.
The tightening of steering wire 1380 at the same time causes a
further deflection in the delivery catheter approximately at point
1420, as shown in FIG. 9B. The tightening of steering wire 1370,
therefore, causes a reverse deflection, returning the delivery
catheter to its original position (see FIG. 9C).
[0188] Referring again to FIG. 7, elongated tube 1010 further
includes lumen 1130 and lumen 1140. Lumen 1130 extends from
approximately the proximal end (not shown) of tube 1010 to or near
distal end 1025 of tube 1010. Lumen 1130 has a bend 1134, relative
to tube 1010, at or near distal end 1025 of tube 1010 and an outlet
1136 through wall 1020 of tube 1010 at or near distal end 1025 of
tube 1010. Similarly, lumen 1140 has a bend 1144, relative to tube
1010, at or near distal end 1025 of tube 1010 and an outlet 1146
through wall 1020 of tube 1010 at or near distal end 1025 of tube
1010. In the embodiment shown in FIG. 7, lumen 1130 is configured
as a laser Doppler tip, and lumen 1140 is sized to accept a
retractable sensing lead 1150 and a pacing lead 1160 having a tip
at the distal end of the lead. The fiberoptic laser Doppler tip
detects and measures blood flow (by measuring the change in
wavelength of light emitted by the tip), which helps the clinician
to identify--and then avoid--blood vessels during lead placement.
Sensing lead 1150 is designed to detect electrical signals in the
heart tissue so that the clinician can avoid placing a pacing lead
into electrically nonresponsive tissue, such as scar tissue. Pacing
lead 1160 is a screw-type lead for placement onto the cardiac
tissue, and its tip, which is an electrode, has a substantially
screw-like shape. Pacing lead 1160 is capable of operative
attachment to a CRT device (not shown) for heart pacing. Although
lead 1160 is used for cardiac pacing, any suitable types of leads
may be used with the delivery catheters described herein, including
sensing leads.
[0189] 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.
[0190] 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).
[0191] 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.
[0192] 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 FIG. 7 can be
used to measure the thickness of the left ventricular wall during
the procedure (in real time) to determine the appropriate target
area for injection.
[0193] Referring again to FIG. 8, although controller 1080
comprises first handle 1090 and second handle 1094, other
embodiments of the controller may include different configurations.
For example, instead of using handles, a controller may include any
suitable torque system for controlling the steering wires of the
steering wire system. Referring now to FIG. 10, there is shown a
portion of a steering wire system 1170 having steering wire 1180,
steering wire 1190, and controller 1200. Controller 1200 comprises
a torque system 1210 having a first rotatable spool 1220, which is
capable of collecting and dispensing steering wire 1180 upon
rotation. For example, when first rotatable spool 1220 rotates in a
certain direction, steering wire 1180 is collected onto spool 1220,
thereby tightening steering wire 1180. When spool 1220 rotates in
the opposite direction, steering wire 1180 is dispensed from spool
1220, thereby loosening steering wire 1180. Torque system 1210 also
has a second rotatable spool 1230, which is capable of collecting
and dispensing steering wire 1190 upon rotation, as described
above.
[0194] 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.
[0195] 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.
[0196] 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.
[0197] Referring again to FIG. 11, there is shown a cross-sectional
view of delivery catheter 1260. Delivery catheter 1260 includes
tube 1265, a first lumen 1270, a second lumen 1280, and a steering
channel 1290. Steering wires 1292, 1294, and 1296 are shown within
steering channel 1290. First lumen 1270 has outlet 1275, which can
be used to deliver a micro-camera system (not shown) or a laser
Doppler tip 1278. Second lumen 1280 is sized to deliver a pacing
lead 1300, as well as a sensing lead (not shown).
[0198] 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.
[0199] Exemplary embodiments of a portion of such an apparatus are
shown in FIGS. 21A and 21B. As shown in FIG. 21A, a perforated
drainage catheter 2100 is provided. Perforated drainage catheter
2100 comprises a tube defining at least one suction/infusion
aperture 2110, and as shown in the embodiment in FIG. 21A,
perforated drainage catheter 2100 defines multiple suction/infusion
apertures 2110. Suction/infusion apertures 2110 are operably
connected to an internal lumen defined within perforated delivery
catheter 2100. It can be appreciated that the portion of perforated
drainage catheter 2100 as shown in FIGS. 21A and 21B may be coupled
to one or more portions of a system for engaging a tissue as
described herein. As such, one or more portions of a system for
engaging a tissue may be used to define a system for removing fluid
as described herein.
[0200] 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/infusion apertures 2110 to allow for a vacuum source
coupled to one end of the channel to provide suction via the
suction/infusion apertures 2110, and one channel operably coupled
to one or more other suction/infusion channels to allow for the
injection of gas, liquid, and/or particulate(s) to a target
site.
[0201] 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/infusion 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/infusion apertures
2110.
[0202] Another exemplary embodiment of a portion of a perforated
drainage catheter 2100 is shown in FIG. 21B. As shown in FIG. 21B,
perforated drainage catheter 2100 comprises a tube with multiple
suction/infusion apertures 2110. However, in this exemplary
embodiment, perforated drainage catheter 2100 comprises a number of
concave grooves 2120 extending a portion of a length of perforated
drainage catheter 2100, whereby the suction/infusion apertures 2110
are provided at the recessed portions therein. Concave grooves
2120, when positioned at least partially around the circumference
of perforated drainage catheter 2100, define one or more ridges
2130 extending a portion of a length of perforated drainage
catheter 2100. Said ridges 2130 of perforated drainage catheter
2100, when positioned at or near a tissue (not shown), aid to
prevent a tissue from coming in direct contact with one or more
suction/infusion apertures 2110. For example, when perforated
drainage catheter 2100 is used in a manner described herein and
when a vacuum is coupled to perforated drainage catheter 2100,
suction from one or more suction/infusion apertures 2110 positioned
within one or more concave grooves 2120 would allow for the removal
of fluid present in the area of perforated drainage catheter 2100.
Ridges 2130 would aid to prevent or minimize tissue adhesion and/or
contact with the one or more suction/infusion apertures 2110.
[0203] 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.
[0204] An exemplary embodiment of a portion of a perforated
drainage catheter 2100 present within a pericardial sac is shown in
FIG. 22. As shown in FIG. 22, perforated drainage catheter 2100 is
first inserted into the heart 2200 using one or more of the
techniques and/or procedures described herein, and is placed
through the right atrial appendage 2210, the visceral pericardium
2215, and into the pericardial sac 2220. The outer portion of the
pericardial sac 2220 is defined by the parietal pericardium 2230. A
pericardial effusion 2240 (fluid within the pericardial sac 2220)
may then be removed using perforated drainage catheter 2100. When a
vacuum source (not shown) is coupled to the proximal end of a
portion of a system for removing fluid (comprising, in part,
perforated drainage catheter 2100 and one or more other components
of a system for engaging a tissue as described herein), the
introduction of a vacuum to perforated drainage catheter 2100
allows the pericardial effusion 2240 (the fluid) to be withdrawn
from the pericardial sac 2220 into one or more suction/infusion
apertures 2110 defined along a length of suction/infusion apertures
2110.
[0205] 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.
[0206] Additional 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.
[0207] 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.
[0208] 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.
[0209] 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.
[0210] An embodiment of a catheter apparatus to improve heart
function according to the present disclosure is shown in FIGS. 23A
and 23B. As shown in FIG. 23A, catheter apparatus 3100 comprises a
suction/infusion catheter 3102 and at least one balloon 3104
capable of inflation. Balloon 3104 may be coupled to a
suction/inflation source 3106 via conduit 3108 coupling balloon
3104 to suction/inflation source 3106. In at least one embodiment,
conduit 3108 comprises a tube positioned within a lumen 3110 of
suction/infusion catheter 3102. In another embodiment, conduit 3108
comprises a tube positioned outside of suction/infusion catheter
3102, but positioned proximally to suction/infusion catheter 3102
so that suction/infusion catheter 3102 and conduit 3108 may be
positioned within a body in a similar manner. It can be appreciated
that conduit 3108 may also comprise a conduit positioned within a
wall of suction/infusion catheter 3102, or may comprise a conduit
coupled to either or both an inner or outer wall of
suction/infusion catheter 3102.
[0211] As shown in FIG. 23A, balloon 3104 is coupled to
suction/infusion catheter 3102. Balloon 3104 is shown in FIG. 23A
in a deflated state, and is shown in an inflated state in the
exemplary embodiment of catheter apparatus 3100 shown in FIG.
23B.
[0212] FIG. 23B shows an embodiment of catheter apparatus 3100
removably coupled to an atrial wall 3112 of a heart. As shown in
FIG. 23B, catheter apparatus 3100 may be positioned through an
aperture in atrial wall 3112 and may be removably coupled to atrial
wall 3112 by inflation and/or deflation of balloon 3104. As shown
in FIG. 23B, catheter apparatus 3100 may be positioned within an
atrial cavity 3114, through atrial wall 3112, and into a
pericardial space 3116, with the portion of catheter apparatus 3100
comprising balloon 3104 positioned at or near the atrial wall 3112.
When positioned, inflation of balloon 3104 causes at least two
portions of balloon 3104 to inflate, at least one portion of
balloon 3104 inflating on either side of atrial wall 3112, or, in
the alternative, inflation of balloon 3104 causes at least two
balloons 3104 to inflate, at least one balloon 3104 positioned on
either side of atrial wall 3112. When balloon 3104 is inflated,
catheter apparatus 3100 becomes removably coupled to atrial wall
3112 and held in place for a period of time desired by a user of
catheter apparatus 3100. It can be appreciated that more than one
balloon 3104, as described above, may be coupled to catheter
apparatus 3100, with inflation of multiple balloons occurring after
inflation from one or more suction/infusion sources 3106. It can be
further appreciated that catheter apparatus 3100 with balloon 3104
may be removably secured within an aperture of an atrial wall 3112
via inflation of balloon 3104 on substantially or fully on one side
of atrial wall 3104, and a ridge, protrusion, or some other
physical structure coupled to catheter apparatus 3100 on the other
side of atrial wall 3112 may function to hold catheter apparatus
3100 in place when balloon 3104 is inflated.
[0213] FIG. 24 shows an embodiment of suction/infusion catheter
3102 positioned within a pericardial space 3116 surrounding a heart
3200. As shown in FIG. 24, suction/infusion catheter 3102 is
positioned within an aperture of atrial wall 3112 and held in place
via inflation of balloon 3104 of suction/infusion catheter 3102.
Suction/infusion catheter 3102 may then be used to inject a
substance, remove a substance via suction, or both, to or from a
target site or target sites within and/or surrounding a heart 3200.
In at least one embodiment, insertion of suction/infusion catheter
3102 is performed under local anesthesia.
[0214] FIGS. 25A and 25B show embodiments of a distal end of
suction/infusion catheter 3102. As shown in FIG. 25A,
suction/infusion catheter 3102 comprises at least one aperture 3300
positioned at or near the distal end of suction/infusion catheter
3102. As shown in the embodiment in FIGS. 25A and 25B,
suction/infusion catheter 3102 defines multiple apertures 3300.
Apertures 3300 are operably connected to an internal lumen defined
within suction/infusion catheter 3102. It can be appreciated that
the portion of suction/infusion catheter 3102 as shown in FIGS. 25A
and 25B may be coupled to one or more portions of a catheter
apparatus 3100 as described herein,
[0215] The internal lumen within suction/infusion catheter 3102 may
define multiple internal channels. For example, suction/infusion
catheter 3102 may define two channels, one channel operably coupled
to one or more apertures 3300 to provide suction, and one channel
operably coupled to one or more other apertures 3300 to allow for
the injection of gas, liquid, and/or particulate(s) to a target
site.
[0216] As described in further detail below, when suction/infusion
catheter 3102 enters a space in a body (a pericardial sac, for
example), suction/infusion catheter 3102 may be used to remove
fluid by the use of suction through one or more apertures 3300.
Suction/infusion catheter 3102 may also be used to deliver gas,
liquid, and/or particulate(s) to a target site through one or more
apertures 3300.
[0217] An exemplary embodiment of a portion of a distal end of a
suction/infusion catheter 3102 is shown in FIG. 25B. As shown in
FIG. 25B, suction/infusion catheter 3102 comprises a tube with
multiple apertures 3300. However, in this exemplary embodiment,
suction/infusion catheter 3102 comprises a number of concave
grooves 3302 extending a portion of a length of suction/infusion
catheter 3102, whereby the apertures 3300 are provided at the
recessed portions therein. Concave grooves 3302, when positioned at
least partially around the circumference of suction/infusion
catheter 3102, define one or more ridges 3304 extending a portion
of a length of suction/infusion catheter 3102. Said ridges 3304 of
suction/infusion catheter 3102, when positioned at or near a tissue
(not shown), aid to prevent a tissue from coming in direct contact
with one or more apertures 3300.
[0218] An exemplary suction/infusion catheter 3102 may also
comprise one or more pressure/volume sensors 3306 as shown in FIGS.
25A and 25B. Pressure/volume sensors 3306 may provide pressure
and/or volume data/readings with respect to the amount of a gas
(helium, for example) to be delivered to or from a pericardial sac
3116.
[0219] An embodiment of a heart assist device 3400 of the present
disclosure is shown in FIG. 26. As shown in FIG. 26, heart assist
device 3400 comprises at least two electromagnetic plates 3402
coupled to a cardiac processor 3404. Cardiac processor 3404 may
optionally be coupled to at least one electromagnetic plate 3402
via one or more wires 3406 as shown in FIG. 26. Bladder 3408 is
positioned at least partially between electromagnetic plates 3402
and is either permanently or removably attached to electromagnetic
plates 3402. In at least one exemplary embodiment, heart assist
device 3400 comprises an electromagnetic plate and a
non-electromagnetic plate. A cardiac processor 3404, which may be,
for example, an electrocardiogram (EKG or ECG), operates to move
electromagnetic plates 3402, wherein electromagnetic plates 3402
may move apart and/or together in relation to one another. As
electromagnetic plates 3402 move about one another, bladder 3408
may inflate and/or deflate in relation to electromagnetic plates
3402. Bladder 3408 may comprise, for example, a polyurethane, a
silastic, or another material suitable for proper function of
bladder 3408. For example, if electromagnetic plates 3402 move
apart from one another, bladder 3408, attached to electromagnetic
plates 3402, would expand/inflate. Expansion/inflation of bladder
3408 may also be facilitated by a gas stored within reservoir 3410.
In at least one embodiment, helium is used as a gas, and is stored
within reservoir 3410.
[0220] The exemplary embodiment of heart assist device 3400 shown
in FIG. 26 shows heart assist device 3400 in a relatively
compressed state, denoting a "systolic time" of a heart 3200. As
shown by the two vertical arrows appearing on electromagnetic
plates 3402, when each electromagnetic plate 3402 moves in the
direction of the vertical arrows, bladder 3408 may become
compressed/deflated, and such compression/deflation may operate to
move a gas in the direction of the horizontal arrow shown in FIG.
26 to suction/infusion catheter 3102 (or to a portion of a catheter
apparatus 3100), whereby a gas may be expelled from one or more
apertures 3300 into a space surrounding a heart 3200. A valve 3412
may be optionally positioned between reservoir 3410 and bladder
3408 to regulate the flow of a gas from reservoir 3410. In at least
one embodiment, valve 3412 is a unilateral valve, regulating the
flow of a gas from reservoir 3410 but not into reservoir 3410. A
pressure/volume sensor 3306 may also be positioned along heart
assist device 3400 to may provide pressure and/or volume
data/readings with respect to the amount of a gas (helium, for
example) to be delivered to or from a pericardial sac 3116.
[0221] An exemplary heart assist device 3400 of the present
disclosure may also optionally comprise a power supply 3414 (a
battery or a rechargeable battery, for example), to provide power
to one or more features of heart assist device 3400, including, but
not limited to, electromagnetic plates 3402, cardiac processor
3404, and a storage device 3416. Power supply 3414 and storage
device 3416 may be coupled to cardiac processor, or may be coupled
to other portions of heart assist device 3400 as may be available
to allow for operation of heart assist device 3400. In at least one
embodiment, power supply 3414 is positioned subcutaneously within a
pectoral area of a patient. Storage device 3416 may retain
measurements (heart data) including, but not limited to, general
heart signals, emissions of signals, EKG systolic/diastolic time,
heart rate ventricular volume, contraction signals, heart wall
thickness, etc. (the aforementioned list being indicative of at
least one parameter of heart data), and such measurements may be
accessible by cardiac processor 3404 to allow for specific
operation of heart assist device 3400. For example, if a heart 3200
is pumping at a rate slower than desired, cardiac processor 3404
may operate to increase the rate of heart pumping by increasing the
rate of introduction and removal of a gas to and/or from a
pericardial space 3116 as described herein, allowing heart assist
device 3400 to function as a pacemaker. Conversely, if a heart 3200
is pumping at a rate faster than desired, cardiac processor 3404
may operate to decrease the rate of heart pumping by decreasing the
rate of introduction and removal of a gas to and/or from a
pericardial space 3116 as described herein. Cardiac processor 3404
may operate in such a manner based upon measurements stored within
storage device 3416. In at least one embodiment, such operation is
initiated following EKG signals received by heart assist device
3400 as described herein. In another embodiment, such operation is
based upon information provided to cardiac processor 3404 from
pressure/volume sensors 3306.
[0222] Another embodiment of a heart assist device 3400 of the
present disclosure is shown in FIG. 27. The exemplary embodiment of
heart assist device 3400 shown in FIG. 27 may contain one or more
elements as shown within the embodiment shown in FIG. 26, but is
not limited to such elements, and may contain more or fewer
elements as desired for a particular embodiment. For purposes of
discussion of the exemplary embodiment shown in FIG. 27, the
elements contained with the exemplary embodiment shown in FIG. 26
are also contained in the exemplary embodiment shown in FIG.
27.
[0223] The exemplary embodiment of heart assist device 3400 shown
in FIG. 27 shows heart assist device 3400 in a relatively inflated
state, denoting a "diastolic time" of a heart 3200. As shown by the
two vertical arrows appearing on electromagnetic plates 3402, when
each electromagnetic plate 3402 moves in the direction of the
vertical arrows, bladder 3408 may become inflated, and such
inflation may operate to move a gas in the direction of the
horizontal arrow shown in FIG. 27 from suction/infusion catheter
3102, whereby a gas may be removed from a space surrounding a heart
3200 via one or more apertures 3300 along suction/infusion catheter
3102.
[0224] FIG. 28 shows an exemplary embodiment of a patient wearing a
heart assist device 3400 of the present disclosure. As shown in
FIG. 28, patient 3600 is wearing heart assist device 3400, wherein
heart assist device 3400 is secured to patient 3600 using, for
example, an optional belt 3602. As shown in FIG. 28, reservoir 3410
is positioned externally to patient 3600. Heart assist device 3400
may operate in a similar function as described within FIGS. 26 and
27, whereby cardiac processor 3404 operates heart assist device
3400 to pump a gas in to and out from a space surrounding a heart
3200 via suction/infusion catheter 3102 to assist the functionality
of heart 3200. Such a heart assist device 3400 may optimally be
relatively small, lightweight, portable, rechargeable, and easy for
a patient 3600 to carry.
[0225] FIG. 29A shows an embodiment of a suction/infusion catheter
3102 of a catheter apparatus 3100 positioned within a heart 3200,
through an atrial wall 3112, and into a pericardial space 3116.
Suction/infusion catheter 3102 may be operable to introduce a gas
(helium, for example), into pericardial space 3116, during
"systolic time" as described herein. In systole, as determined by
EKG, for example, the infusion of a gas from pericardial space 3116
is made to compress heart 3200 and reduce heart 3200 wall
dimensions, resulting in a decrease in wall stress. During
contraction of heart 3200 ("systolic time"), pericardial space 3116
may partially fill with a gas, assisting heart 3200 with its
contraction. The synchronized compressive pressure by the gas in
the pericardial space 3116 over heart 3200 during the systolic time
reinforces the blood ejection from the ventricles of heart
3200.
[0226] A gas may be introduced into pericardial space 3116 as
described within the description relating to FIG. 26 herein.
Expansion of a pericardial space 3116 using a gas exerts pressures
on the various walls of heart 3200 as shown by the arrows in FIG.
29A. Such an expansion may not only assist the heart 3200 with its
contraction function, but may also provide additional beneficial
support to a pericardial wall.
[0227] FIG. 29B also shows an embodiment of a suction/infusion
catheter 3102 of a catheter apparatus 3100 positioned within a
heart 3200, through an atrial wall 3112, and into a pericardial
space 3116. Suction/infusion catheter 3102 may be operable to
introduce remove a gas (helium, for example), from pericardial
space 3116, during "diastolic time" as described herein. In
diastole, as determined by EKG, for example, the removal of a gas
from pericardial space 3116 is made to un-load heart 3200 and
increase myocardial flow, resulting in increased perfusion. The
deflation of the pericardial space 3116 due to gas suction during
diastolic time reduces the compressive pressure over the heart 3200
and facilitates the expansion/filling of the chambers of heart 3200
with blood. A gas may be removed from pericardial space 3116 as
described within the description relating to FIG. 27 herein,
[0228] During expansion of heart 3200 ("diastolic time"), gas may
partially or fully expel from pericardial space 3116, assisting
heart 3200 with its expansion. Removal of gas from pericardial
space 3116 assists the expansion of an internal heart chamber as
shown by the arrows in FIG. 29B, noting that as gas is expelled
from a pericardial space 3116, the innermost pericardial wall would
be pulled inward (as shown by the arrows), assisting with the
expansion of a chamber of heart 3200 as it fills with blood. As
such, pericardial space 3116 functions as a pump bladder of heart
3200 using a catheter apparatus 3100 of the present disclosure. For
example, the parietal pericardium and the visceral pericardium have
pumping characteristics of a pump bladder, wherein a gas inflates
the pump bladder to provide a compressive pressure on heart 3200
during systolic time and deflating the pump bladder by gas suction
during diastolic time. Furthermore, the amount of gas may be
increased and/or decreased as desired according to hemodynamic
parameters made available to cardiac processor 3404.
[0229] FIGS. 30A and 30B show embodiments of a distal end of
suction/infusion catheter 3102 with a pericardial balloon 3700
coupled thereto. As shown in FIG. 30A, suction/infusion catheter
3102 comprises at least one aperture 3300 positioned at or near the
distal end of suction/infusion catheter 3102. As shown in the
embodiments in FIGS. 30A and 30B, suction/infusion catheter 3102
defines multiple apertures 3300. Apertures 3300 are operably
connected to an internal lumen defined within suction/infusion
catheter 3102. It can be appreciated that the portion of
suction/infusion catheter 3102, as shown in FIGS. 30A and 30B, may
be coupled to one or more portions of a catheter apparatus 3100 as
described herein.
[0230] The exemplary embodiment of a suction/infusion catheter 3102
shown in FIG. 30A is shown with a deflated pericardial balloon
3700. In at least one procedure wherein suction/infusion catheter
3102 is introduced into a pericardial space 3116 surrounding a
heart 3200, suction/infusion catheter 3102 may have a deflated
pericardial balloon 3700 coupled thereto, so that suction/infusion
catheter 3102 may be more readily inserted into the pericardial
space 3116. As shown in the embodiment shown in FIG. 30B,
suction/infusion catheter 3102 is shown with an inflated
pericardial balloon 3700. In at least one procedure wherein
suction/infusion catheter 3102 is introduced into a pericardial
space 3116 surrounding a heart 3200, pericardial balloon 3700 may
be inflated by an inflation source, including, but not limited to,
suction/inflation source 3106. It can be appreciated that any
number of inflation sources known in the art may be used to inflate
pericardial balloon 3700.
[0231] Pericardial balloon 3700 may comprise any material suitable
for a particular application, including, but not limited to, a
polyurethane pericardial balloon 3700, and may comprise any number
of inflated pericardial balloon 3700 volumes, including, but not
limited to, a 30 cc or a 40 cc pericardial balloon 3700.
[0232] FIGS. 31A and 31B show exemplary embodiments of
suction/infusion catheter 3102 positioned within the pericardial
space 3116 surrounding a heart 3200. In the exemplary embodiment
shown in FIG. 31A, suction/infusion catheter 3102 is shown
positioned within an atrial appendage, through an atrial wall 3112,
and into the pericardial space 3116 surrounding the heart 3200. In
this embodiment, suction/infusion catheter 3102 comprises a
pericardial balloon 3700 positioned at or near the distal end of
suction/infusion catheter 3102, wherein pericardial balloon 3700 is
deflated (during "diastolic time"). This exemplary embodiment and
other embodiments may be coupled to and become part of a device
and/or apparatus of the present disclosure.
[0233] As shown in FIG. 31 B, an exemplary embodiment of a
suction/infusion catheter 3102 positioned within the pericardial
space 3116 surrounding a heart 3200 is shown. In this exemplary
embodiment, pericardial balloon 3700 is shown positioned within the
pericardial space 3116 surrounding heart 3200 with pericardial
balloon 3700 inflated (during "systolic time"). Pericardial balloon
3700 may be inflated using suction/inflation source 3106, or using
another inflation source operably coupled to the internal lumen of
suction/infusion catheter 3102, wherein gas may be introduced into
the lumen of suction/infusion catheter by, for example, a
suction/inflation source 3106 or another inflation source coupled
to the suction/infusion catheter 3102, to enter pericardial balloon
3700 via the one or more apertures 3300 defined therethrough. In at
least one embodiment, a conduit (not shown) may be used to connect
suction/inflation source 3106 or another inflation source to
pericardial balloon 3700 to facilitate inflation and/or deflation
of pericardial balloon 3700. As will be provided in further detail
herein, positioning a suction/infusion catheter 3102 within a
specific area within the pericardial space 3116 surrounding the
heart 3200 will allow for localized inflation and/or deflation of
the pericardial balloon 3700, allowing the pericardial balloon 3700
to potentially contact the epiardial wall at or near a desired
chamber of a heart 3200.
[0234] FIGS. 32A and 32B show exemplary embodiments of
suction/infusion catheters 3012 comprising pericardial balloons
3700 positioned within the pericardial space 3116 surrounding a
heart 3200. A shown in FIG. 32A, suction/infusion catheter 3102 is
positioned through an aperture in the atrial wall 3112 and into the
pericardial space 3116 surrounding a heart 3200. In this
embodiment, suction/infusion catheter 3102 is positioned within the
pericardial space 3116 near the left ventricle of the heart 3200.
In this exemplary embodiment, pericardial balloon 3700 may be
inflated during systolic time of the heart 3200, facilitating a
heart beat. For example, if a heart 3200 is damaged, and the left
ventricle is unable to properly beat to pump blood, positioning a
suction/infusion catheter 3102 within the pericardial space 3116
near the left ventricle of the heart 3200, and inflating the
pericardial balloon during systolic time, the natural beat of the
heart 3200 along with the inflation of pericardial balloon 3700
exerting pressure on the epicardial wall outside the left ventricle
would facilitate a stronger heart beat, and thus overall heart 3200
function.
[0235] FIG. 32B shows an exemplary embodiment of a device/apparatus
as described herein comprising multiple suction/infusion catheters
3102. In this exemplary embodiment, two suction/infusion catheters
3102 are provided, with each suction/infusion catheter 3102
comprising a pericardial balloon 3700. It can be appreciated that a
device/apparatus of the present disclosure may comprise any number
and/or types of catheters, including, but not limited to, multiple
suction/infusion catheters 3102, as may be desired for a particular
application.
[0236] In the exemplary embodiment shown in FIG. 32B, one
suction/infusion catheter 3102 is positioned within the pericardial
space 3116 at or near the left ventricle of the heart 3200, and
another suction/infusion catheter 3102 is positioned within the
pericardial space 3116 at or near the right ventricle of the heart
3200. An embodiment comprising two or more suction/infusion
catheters 3102 with pericardial balloons 3700 allow for inflation
and/or deflation of two pericardial balloons 3700 either at the
same time, allowing for "counterpulsation" of the two balloons 3700
when inflated and/or deflated. As a pericardial balloon 3700
positioned within a pericardial space 3116 is inflated, pericardial
balloon 3700 may exert a pressure against the epicardial wall, with
such pressure facilitating the beating of a heart 3200.
[0237] Several advantages exist for a catheter system 3100 and
heart assist device 3400 of the present disclosure, including
non-blood contact (as at least a portion of catheter system 3100
would be positioned within a pericardial space 3116 when in use),
and that no intravascular power source, pumps, and or valves are
required. As portions of such a system/device may be introduced to
a patient 3600 under local anesthesia, as no formal/invasive
surgical procedure is required, reducing risks of infection,
embolism, bleeding, and material fatigue.
[0238] In addition, portions of a system/device are relatively easy
to insert and remove, and as such a system/device does not require
the use of pharmaceuticals, no drug treatment contraindications
would exist. Furthermore, as a reservoir 3410 would be positioned
externally to the body of a patient 3600, it may be completely
rechargeable without patient 3600 complication during the
replacement period. Such a system/device may also measure on line
cardiac rhythm, ventricular volumes displacements, pressure, etc.,
to tailor the treatment for a specific patent 3600. Furthermore,
such a system/device would allow a patient 3600 to be freely mobile
without discomfort.
[0239] It can be appreciated that a heart assist device 3400 as
described herein may comprise other means of injecting and/or
removing a gas from a pericardial space 3116. For example, and
instead of using one or more electromagnetic plates 3402 and a
bladder 3408, heart assist device may instead use a piston as the
gas injection/removal mechanism, whereby said piston have the same
effect in operation as the operation of a heart assist device using
one or more electromagnetic plates 3402 and a bladder 3408 as
described herein.
[0240] The devices, systems, and methods of the present disclosure
provide for hemodynamic control during a procedure as disclosed
herein, utilizing, for example, mean arterial pressure, wedge
pressure, central venous pressure, cardiac output, and cardiac
index. Evaluation of ventricular function with echocardiograms,
nuclear magnetic resonance (NMR), or myocardial echo contrast, for
example, may also be performed consistent with the methods of the
present disclosure. In addition to the foregoing, the present
disclosure allows for easy insertion and removal of a
suction/infusion catheter 2306.
[0241] While various embodiments of systems and methods for closing
an aperture in a bodily tissue 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.
[0242] 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.
* * * * *
References