Various aspects of the present disclosure relate generally to medical systems, devices, and related methods. More specifically, the present disclosure relates to medical systems and/or devices for delivering pharmaceutical therapy under reverse blood flow.
Vasculature of a subject (also referred to as patient) may occasionally become stenosed, occluded, partially occluded, blocked, narrowed, or otherwise compromised such that transfer of blood through the vasculature is impeded, lessened, and/or prevented. That is, the blood carrying capacity of such a compromised vessel is reduced or otherwise insufficient. The vasculature may become occluded, stenosed, or at least partially blocked due to the deposit of plaque, emboli, or other such material on the walls of the vasculature. To avoid serious and/or permanent injury, one or more medical procedures or interventions may be performed. Such procedures may include, for example, angioplasty, atherectomy, stenting, or the like in which a constricted, narrowed, occluded, or otherwise partially blocked region of the vasculature is opened, widened, or unblocked so as to allow or maintain blood flow therethrough. Additionally, such procedures may involve delivery of a pharmaceutical agent to treat, reduce the size of, break apart or fragment a clot or other such tissue or blockage within the constricted, narrowed, occluded, or otherwise partially blocked region of the vasculature so as to provide a therapeutic benefit to the patient. Often such procedures further dilate the artery and loosen and/or fragment plaque, emboli, or other such material. The fragmented plaque, emboli, or other material may travel downstream with a flow of blood passing through the vasculature and potentially result in a stroke or other embolic event.
The systems, devices, and methods of the current disclosure may rectify some of the deficiencies described above or address other aspects of the prior art.
Examples of the present disclosure relate to, among other things, medical devices and procedures. Each of the examples disclosed herein may include one or more of the features described in connection with any of the other disclosed examples.
In one example, a method may include positioning a first device within an internal carotid artery of a subject and impeding antegrade blood flow in the internal carotid artery. Additionally, the method may include delivering a pharmaceutical agent through an external carotid artery for passage into an ophthalmic artery of the subject.
In another example, a method may include impeding antegrade blood flow in an internal carotid artery of a subject via a first device and positioning a distal end of a second device distally of a junction between an external carotid artery and a common carotid artery. The method may also include delivering a pharmaceutical agent via the second device through the external carotid artery for passage into an ophthalmic artery of the subject.
In a further example, a method may include impeding antegrade blood flow in an internal carotid artery of a subject via a first device and delivering a pharmaceutical agent through an external carotid artery for passage into an ophthalmic artery of the subject. Additionally, the method may include treating a blockage, a stenosis, a lesion, plaque, or other physiology in the ophthalmic artery or a junction between the ophthalmic artery and the internal carotid artery.
Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms “comprises,” “comprising,” “having,” “including,” or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not necessarily include only those elements but, may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. Additionally, the term “exemplary” is used herein in the sense of “example,” rather than “ideal.” As used herein, the terms “about,” “substantially,” and “approximately,” indicate a range of values within +/−5% of the stated value unless otherwise stated.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary features of the present disclosure and together with the description, serve to explain the principles of the disclosure.
Examples of the present disclosure relate to medical systems, devices, and methods for treating internal areas of a patient's body by establishing reverse blood flow in the OA, and delivering a pharmaceutical agent to the OA via the induced reverse blood flow pathway.
Reference will now be made in detail to examples of the present disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
The terms “proximal” and “distal” are used herein to refer to the relative positions of the components of an exemplary medical device or insertion device. When used herein, “proximal” refers to a position relatively closer to the exterior of the body or closer to a medical professional using the medical device or insertion device. In contrast, “distal” refers to a position relatively further away from the medical professional using the medical device or insertion device, or closer to the interior of the body.
The terms “downstream” or “antegrade” and “upstream” or “retrograde,” when used herein in relation to the subject's vasculature, refer respectively, to the direction of blood flow and the direction opposite that of blood flow, respectively. In the arterial system, “downstream” or “antegrade” refers to the direction further from the heart, while “upstream” or “retrograde” refers to the direction closer to the heart.
“Reverse flow,” as used herein, is the flow of blood opposite to the direction of blood flow under normal blood flow conditions. In this disclosure, “reverse flow” and “retrograde flow” are used synonymously. Reverse flow may be achieved by creating a pressure gradient, so blood flow is reversed and directed, for example, from the treatment site into a lumen of a medical device to be rerouted to another location.
Sheath 30 (e.g., a catheter) may include a plurality of lumens. At least one of such lumens may be a balloon inflation lumen having a first end fluidly coupled with a source of inflation fluid 38 (e.g., a gas such as air, or a liquid such as water or saline) and a second end fluidly coupled to an interior of balloon 32 via a side port/valve (not shown), such that upon delivery of fluid from source 38 to balloon 32, balloon 32 may expand from a first, uninflated configuration (not shown) to an expanded configuration as shown in
A second lumen of sheath 30 may extend between a proximal end and a distal end of sheath 30, e.g., distal to balloon 32. The second lumen may be a guide lumen such that sheath 30 and balloon 32 may be delivered over a guidewire or the like via the second lumen. Such a second lumen may be configured for “rapid exchange” (RE) delivery or “over-the-wire” (OTW) delivery.
A sheath 40 may be delivered through the second lumen of sheath 30 to a location distal of sheath 30. For example, as shown in
An additional catheter 50 may be advanced into ECA 8. Notably, a distal end 52 of catheter 50 may be positioned at any location within ECA 8 (or an associated branch of ECA 8) distal of the junction between ICA 2, ECA 8, and CCA 10. In the arrangement shown in
Once so positioned, a pharmaceutical agent 60 may be delivered from a source 62 fluidly coupled with catheter 50. The pharmaceutical agent 60 may include, but is not limited to, any one or more of vasodilators (e.g., adenosine, PDE5 inhibitors, nitric oxide donors, and epinephrine), thrombolytics (e.g., urokinase, streptokinase, anistreplase, and recombinant tissue plasminogen activators), antioxidants (e.g., uric acid, glutathione, melatonin, dismutase, catalase, peroxiredoxins, and thioredoxin), anti-coagulants (e.g., heparin, coumadin, and synthetic penta saccharides), ACE inhibitors (e.g., perindopril, captopril, benazepril, and zofenopril), antihistamines (e.g., diphenhydramine, loratadine, fexofenadine and hydroxyzine), beta blockers (e.g., propranolol, carvedilol, and oxprenolol), calcium channel blockers (e.g., aranidipine, lacidipine, nifedipine, and nitrendipine), NSAIDS (e.g., ibuprofen, and naproxen), and/or corticosteroids (e.g., cortisol, corticosterone, cortisone, and aldosterone). These may also include families of diuretics, angiotensin II receptor antagonists, adrenergic receptor antagonist, renin inhibitors, aldosterone receptor antagonists, alpha-2 adrenergic receptor agonists, endothelin receptor blockers or any pharmaceutical or combination of pharmaceutics that provide a benefit to the vasculature.
Pharmaceutical agent 60 may be delivered via a lumen of catheter 50 from a pharmaceutical source 62. Optionally, perfusion of pharmaceutical agent 60 may be pressurized via a pressurizer 66 (e.g., syringe, power injector, pump, etc.). Pressurizer 66 may be either an automatic or manually operated pressurizer. For example, an automatic pressurizer may include a motor (not shown) to deliver a constant source of pressure to the pharmaceutical agent 60. Alternatively, a manual pressurizer (e.g., syringe) may be employed to provide a medical professional with selective control of the pressure of perfusion of pharmaceutical agent 60. Optionally, pressurizer 66 may be controlled via a regulator 64 to ensure appropriate pressurization of pharmaceutical agent 60. Pressurization of pharmaceutical agent 60 may be desired depending on one or more of a tortuosity of the anatomical location of distal end 52 of the catheter 50, a cross-sectional dimension (e.g., diameter) of the lumen of catheter 50, a cross-sectional dimension of a target anatomical location for perfusion of pharmaceutical agent, and/or a composition (e.g., viscosity, etc.) of pharmaceutical agent 60. While references throughout the present disclosure relate to delivery of pharmaceutical agent 60, the disclosure is not so limited. Rather, any appropriate diagnostic and/or therapeutic fluid/agent may be delivered as described herein via catheter 50. Examples of such diagnostic and/or therapeutic fluid/agents may include: ionic contrast media (e.g., barium sulfate, propyliodone, iodoxamic acid, metrizamide and diatrizoic acid), nonionic contrast media (e.g., barium sulfate), paramagnetic contrast media (e.g., gadobenic acid, gadolinium, and mangafodipir), super magnetic contrast media (e.g., ferumoxsil, ferristene, and iron oxide) and contrast agents (e.g., dyes, and radiologic tracers).
In use, a medical professional may access ICA 2 via any appropriate manner (e.g., an arterial cut down, etc.). Additionally, the medical professional may position a guidewire within the vasculature of a subject, extending an end of the guidewire into ICA 2 to a position distal of a junction between CCA 10 and ECA 8. Once so positioned, sheath 30 may be advanced over the guidewire into position within ICA 2. Radiopaque or other markers may be positioned on one or more portions of sheath 30 so as to assist in longitudinal and rotational positioning of sheath 30 and balloon 32 via suitable imaging or other viewing techniques. Once sheath 30 is positioned, the guidewire may be removed from the lumen of sheath 30. Alternatively, the guidewire may remain within the lumen during a remainder of the procedure.
Next, balloon 32 may be expanded, as shown at arrow 7 of
Additionally, catheter 50 may be advanced into the arterial system and arranged so as to perfuse a pharmaceutical agent 60 into ECA 8, or one or more branches thereof (indicated at arrow 5 of
Optionally, interventional device 42 may be advanced through sheath 40 and into OA 4 (indicated at arrow 6 of
In some arrangements, catheter 50 may be a multi-lumen catheter. In such an arrangement, a first pharmaceutical agent may be perfused into the arterial system of a patient via a first lumen of catheter 50, while a second pharmaceutical agent may be perfused into the arterial system of a patient via a second lumen of catheter 50. For example, as shown in
As shown, first lumen 54 is coupled to second lumen 56. To facilitate relative movement between first lumen 54 and second lumen 56 of catheter 50, a wall defining first lumen 54 may include an opening, track, or groove 54A, while a wall defining second lumen 56 may include a correspondingly shaped or configured protrusion 56A for being mated to or received within groove 54A, as shown in
In some aspects, an exemplary kit 100, as shown in
While principles of the present disclosure are described herein with reference to illustrative examples for particular applications, it should be understood that the disclosure is not limited thereto. For example, in any of the above noted arrangements, rather than returning induced retrograde blood flow through a filter and into a venous return site, the blood may be removed via a source of negative pressure (e.g., suction from a syringe) and discarded. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, embodiments, and substitution of equivalents all fall within the scope of the features described herein. Accordingly, the claimed features are not to be considered as limited by the foregoing description.
This patent application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 62/634,325, filed Feb. 23, 2018, which is herein incorporated by reference in its entirety.
Number | Name | Date | Kind |
---|---|---|---|
2690595 | Raiche | Oct 1954 | A |
3367101 | Garnet et al. | Feb 1968 | A |
3435826 | Fogarty | Apr 1969 | A |
4403612 | Fogarty | Sep 1983 | A |
4445897 | Ekbladh et al. | May 1984 | A |
4926858 | Gifford, III et al. | May 1990 | A |
5026384 | Farr et al. | Jun 1991 | A |
5176693 | Pannek, Jr. | Jan 1993 | A |
5336234 | Vigil et al. | Aug 1994 | A |
5395311 | Andrews | Mar 1995 | A |
5419761 | Narayanan et al. | May 1995 | A |
5709701 | Parodi | Jan 1998 | A |
5820595 | Parodi | Oct 1998 | A |
5897567 | Ressemann et al. | Apr 1999 | A |
5972019 | Engelson et al. | Oct 1999 | A |
6146370 | Barbut | Nov 2000 | A |
6206868 | Parodi | Mar 2001 | B1 |
6302908 | Parodi | Oct 2001 | B1 |
6336933 | Parodi | Jan 2002 | B1 |
6344054 | Parodi | Feb 2002 | B1 |
6413235 | Parodi | Jul 2002 | B1 |
6423032 | Parodi | Jul 2002 | B2 |
6540712 | Parodi et al. | Apr 2003 | B1 |
6595980 | Barbut | Jul 2003 | B1 |
6623471 | Barbut | Sep 2003 | B1 |
6626861 | Hart et al. | Sep 2003 | B1 |
6641573 | Parodi | Nov 2003 | B1 |
6645222 | Parodi et al. | Nov 2003 | B1 |
6824558 | Parodi | Nov 2004 | B2 |
6827726 | Parodi | Dec 2004 | B2 |
6837881 | Barbut | Jan 2005 | B1 |
6855162 | Parodi | Feb 2005 | B2 |
6902540 | Dorros et al. | Jun 2005 | B2 |
6905490 | Parodi | Jun 2005 | B2 |
6908474 | Hogendijk et al. | Jun 2005 | B2 |
6929634 | Dorros et al. | Aug 2005 | B2 |
6936053 | Weiss | Aug 2005 | B1 |
6936060 | Hogendijk et al. | Aug 2005 | B2 |
7214201 | Burmeister et al. | May 2007 | B2 |
7235095 | Haverkost et al. | Jun 2007 | B2 |
7309334 | Von Hoffmann | Dec 2007 | B2 |
7604612 | Ressemann et al. | Oct 2009 | B2 |
7806906 | Don Michael | Oct 2010 | B2 |
7867273 | Pappas et al. | Jan 2011 | B2 |
7901445 | Walker et al. | Mar 2011 | B2 |
7927347 | Hogendijk et al. | Apr 2011 | B2 |
8157760 | Carido et al. | Apr 2012 | B2 |
8353850 | Ressemann et al. | Jan 2013 | B2 |
8414516 | Chang | Apr 2013 | B2 |
8545432 | Renati et al. | Oct 2013 | B2 |
8834404 | Beaudin | Sep 2014 | B2 |
8852226 | Gilson et al. | Oct 2014 | B2 |
8863631 | Janardhan et al. | Oct 2014 | B1 |
9078682 | Lenker et al. | Jul 2015 | B2 |
9241699 | Kume et al. | Jan 2016 | B1 |
9259215 | Chou et al. | Feb 2016 | B2 |
9265512 | Garrison et al. | Feb 2016 | B2 |
9987164 | Calhoun | Jun 2018 | B2 |
20010001114 | Tsugita et al. | May 2001 | A1 |
20020087128 | Paques et al. | Jul 2002 | A1 |
20020143291 | Slater | Oct 2002 | A1 |
20020151922 | Hogendijk et al. | Oct 2002 | A1 |
20030023200 | Barbut et al. | Jan 2003 | A1 |
20030023227 | Zadno-Azizi et al. | Jan 2003 | A1 |
20030040694 | Dorros | Feb 2003 | A1 |
20030199802 | Barbut | Oct 2003 | A1 |
20030199819 | Beck | Oct 2003 | A1 |
20030203958 | Kunz et al. | Oct 2003 | A1 |
20050149117 | Khosravi et al. | Jul 2005 | A1 |
20060136022 | Wong, Jr. et al. | Jun 2006 | A1 |
20060259132 | Schaffer et al. | Nov 2006 | A1 |
20070026035 | Burke et al. | Feb 2007 | A1 |
20080027519 | Guerrero | Jan 2008 | A1 |
20080243229 | Wallace et al. | Oct 2008 | A1 |
20090018455 | Chang | Jan 2009 | A1 |
20090024072 | Criado et al. | Jan 2009 | A1 |
20090030323 | Fawzi et al. | Jan 2009 | A1 |
20100125244 | McAndrew | May 2010 | A1 |
20110143993 | Langer et al. | Jun 2011 | A1 |
20110152683 | Gerrans et al. | Jun 2011 | A1 |
20110160762 | Hogendijk et al. | Jun 2011 | A1 |
20110319754 | Solar | Dec 2011 | A1 |
20120046679 | Patel et al. | Feb 2012 | A1 |
20120078287 | Barbut | Mar 2012 | A1 |
20120101510 | Lenker et al. | Apr 2012 | A1 |
20130035628 | Garrison et al. | Feb 2013 | A1 |
20130197621 | Ryan et al. | Aug 2013 | A1 |
20130281788 | Garrison | Oct 2013 | A1 |
20140154246 | Robinson et al. | Jun 2014 | A1 |
20150173782 | Garrison | Jun 2015 | A1 |
20150313607 | Zhadkevich | Nov 2015 | A1 |
20150366580 | Lenihan et al. | Dec 2015 | A1 |
20160166754 | Kassab et al. | Jun 2016 | A1 |
Number | Date | Country |
---|---|---|
WO 9852639 | Nov 1998 | WO |
WO 9853761 | Dec 1998 | WO |
WO 0054673 | Sep 2000 | WO |
WO 03018085 | Mar 2003 | WO |
WO 2007103464 | Sep 2007 | WO |
WO 2014022866 | Feb 2014 | WO |
WO 2016109586 | Jul 2016 | WO |
WO 2017156333 | Sep 2017 | WO |
WO 2018053121 | Mar 2018 | WO |
WO 2018106858 | Jun 2018 | WO |
Entry |
---|
Altinbas, N.K. et al, “Effect of Carotid Artery Stenting on Ophthalmic Artery Flow Patterns,” Journal of Ultrasound Medicine, 2014; 33: pp. 629-638. |
Ambarki, K. et al., “Blood Flow of Ophthalmic Artery in Healthy Individuals Determined by Phase-Contrast Magnetic Resonance Imaging,” Investigative Ophthalmology & Visual Science, 2013; 54: pp. 2738-2745. |
Hayreh, S.S., “The Ophthalmic Artery III. Branches,” British Journal of Ophthalmology, 1962, 46, pp. 212-247. |
Hwang, G. et al., “Reversal of Ischemic Retinopathy Following Balloon Angioplasty of a Stenotic Ophthalmic Artery.” Journal of Neuro-Ophthalmology 30.3, 2010, pp. 228-230. |
Kane, A.G. et al., “Reduced Caliber of the Internal Carotid Artery: A Normal Finding with Ipsilateral Absence or Hypoplasia of the A1 Segment,” American Journal of Neuroradiology, 1996; 17: pp. 1295-1301. |
Kawa, M.P. et al., “Complement System in Pathogenesis of AMD: Dual Player in Degeneration and Protection of Retinal Tissue,” Hindawi Publishing Corporation, Journal of Immunology Research, vol. 2014, Article ID 483960, 12 pages. |
Klein, R. et al., “Vasodilators, Blood Pressure-Lowering Medications, and Age-Related Macular Degeneration,” American Academy of Ophthalmology, 2014, vol. 121, Issue 8, pp. 1604-1611. |
Kooragayala, K. et al., “Quanitification of Oxygen Consumption in Retina Ex Vivo Demonstrates Limited Reserve Capacity of Photoreceptor Mitochondria,” Investigative Ophthalmology & Visual Science, 2015; 56: pp. 8428-8436. |
Krejza, J. et al., “Carotid Artery Diameter in Men and Women and the Relation to Body and Neck Size,” Stroke, 2006; 3 pages. |
Lanzino, G. et al., “Treatment of Carotid Artery Stenosis: Medical Therapy, Surgery, or Stenting?,” Mayo Clinic Proceedings, Apr. 2009; 84(4), pp. 362-368. |
Michalinos, A. et al., “Anatomy of the Ophthalmic Artery: A Review concerning Its Modern Surgical and Clinical Applications,” Hindawi Publishing Corporation, Anatomy Research International, vol. 2015, Article ID 591961, 8 pages. |
Paques, M. et al., “Superselective ophthalmic artery fibrinolytic therapy for the treatment of central retinal vein occlusion.” British Journal of Ophthalmology, 2000, 84: 1387-1391. |
Tan, P.L. et al., “AMD and the alternative complement pathway: genetics and functional implications,” Human Genomics, 2016, 10:23, 13 pages. |
Xu, H. et al., “Targeting the complement system for the management of retinal inflammatory and degenerative diseases,” European Journal of Pharmacology, 2016, 787, pp. 94-104. |
Yamane, T. et al., “The technique of ophthalmic arterial infusion therapy for patients with intraocular retinoblastoma,” International Journal of Clinical Oncology, Apr. 2004; vol. 9, Issue 2, pp. 69-73. |
Zeumer, H. et al., “Local intra-arterial fibrinolytic therapy in patients with stroke: urokinase versus recombinant tissue plagminogen activator (r-TPA),” Neuroradiology, 1993; 35: pp. 159-162. |
Zipfel, P.F., et al., “The Role of Complement in AMD,” Inflammation and Retinal Disease: Complement Biology and Pathology, Advances in Experimental Medicine and Biology, 2010, 703, pp. 9-24. |
Examination Report No. 2 for AU Application No. 2013296195, dated Jun. 27, 2017 (6 pages). |
Notice of Allowance for KR 20157005602, dated Sep. 25, 2017 (3 pages). |
Loh, K. et al., “Prevention and management of vision loss relating to facial filler injections.” Singapore Medical Journal, 2016; 57(8): 438-443. |
International Search Report and Written Opinion for International Application No. PCT/US2017/0051551, dated Dec. 15, 2017 (14 pages). |
International Search Report and Written Opinion for International Application No. PCT/US2017/0052901, dated Dec. 8, 2017 (9 pages). |
International Search Report and Written Opinion for International Application No. PCT/US2018/031229, dated Jul. 27, 2018 (19 pages). |
Bird, B. et al., “Anatomy, Head and Neck, Ophthalmic Arteries,” NCBI Bookshelf, a service of the National Library of Medicine, National Institutes of Health, Oct. 27, 2018, 5 pages. |
www.ncbi.nlh.nih.gov/books/NBK482317/?report=printable. |
Hattenbach, L. et al., “Experimental Endoscopic Endovascular Cannulation: A Novel Approach to Thrombolysis in Retinal Vessel Occlusion,” Investigative Ophthalmology & Visual Science, Jan. 2012, vol. 53, No. 1, pp. 42-46. |
Khan, T.T. et al., “An Anatomical Analysis of the Supratrochlear Artery: Considerations in Facial Filler Injections and Preventing Vision Loss,” Aesthetic Surgery Journal, 2017, vol. 37(2), pp. 203-208. |
Schumacher, M. et al., “Intra-arterial fibrinolytic therapy in central retinal artery occlusion,” Neurology (1993) 35: pp. 600-605. |
Schwenn, O.K. et al., “Experimental Percutaneous Cannulation of the Supraorbital Arteries: Implication for Future Therapy,” Investigative Ophthalmology & Visual Science, May 2005, vol. 46, No. 5, pp. 1557-1560. |
Wang, R. et al., “Evaluation of Ophthalmic Artery Branch Retrograde Intervention in the Treatment of Central Retinal Artery Occlusion (CRAO),” Medical Science Monitor, 2017, 23: pp. 114-120. |
Zhao, W. et al. “Three-Dimensional Computed Tomographic Study on the Periorbital Branches of the Ophthalmic Artery: Arterial Variations and Clinical Relevance,” Aesthetic Surgery Journal, 2018, pp. 1-9. |
International Search Report and Written Opinion for corresponding PCT/US2013/053670, dated Dec. 26, 2013 (16 pp.). |
Hayreh et al., “Ocular Arterial Occlusive Disorders and Carotid Artery Disease,” American Academy of Ophthalmology, 2017; vol. 1, No. 1: pp. 12-18. |
Hayreh et al., “The Ophthalmic Artery,” Brit. J. Ophthal., 1962; 46, 65: pp. 65-98. |
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20190262000 A1 | Aug 2019 | US |
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62634325 | Feb 2018 | US |