IPR2018-00107
`Ex. 3001
`
`(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`(19) World Intellectual Property
`Organization
`International Bureau
`
`(43) International Publication Date
`6 August 2015 (06.08.2015)
`
`P O P C T
`
`(10) International Publication Number
`WO 2015/117025 Al
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`(51) International Patent Classification:
`A61M 3/00 (2006.01)
`
`(21) International Application Number:
`
`(22) International Filing Date:
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`PCT/US2015/013956
`
`30 January 2015 (30.01 .2015)
`
`English
`
`English
`
`(30) Priority Data:
`61/934,250
`
`3 1 January 2014 (3 1.01.2014)
`
`(71) Applicant: CEDARS-SINAI MEDICAL CENTER
`[US/US]; 8700 Beverly Boulevard, Los Angeles, Califor
`nia 90048 (US).
`
`(72) Inventor: AL-JILAIHAWL Hasanian; 427 Westbourne
`Drive, Los Angeles, California 90048 (US).
`
`(74) Agents: VAKHARIA-RAO, Hema et al; Nixon Peabody
`LLP, Gas Company Tower, 555 West Fifth Street, 46th
`Floor, Los Angeles, California 90013 (US).
`
`(81) Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY,
`BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM,
`DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT,
`HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR,
`KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG,
`MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM,
`PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC,
`SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN,
`TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
`
`(84) Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ,
`TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU,
`TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE,
`DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU,
`LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK,
`SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ,
`GW, KM, ML, MR, NE, SN, TD, TG).
`
`[Continued on nextpage]
`
`(54) Title: PIGTAIL FOR OPTIMAL AORTIC VALVULAR COMPLEX IMAGING AND ALIGNMENT
`
`(57) Abstract: In various embodiments, provided herein are devices,
`systems and methods using two, three or more pigtails for precisely
`imaging an aortic valve complex with minimal contrast and/or for ad
`vancing an instrument, such as a wire, or device, such as a transcath-
`eter valve, across an aortic valve. In various embodiments,
`these
`devices, systems and methods may be used to diagnose and/or treat
`patients with aortic stenosis, other valvular heart disease or other car
`diovascular or non cardiovascular disease, facilitating precise con
`trast or drug or device delivery, precise pressure measurement and/or
`precise drainage or sampling. In some embodiments, each of the mul
`tiple pigtails of the device may be advanced independently of one an
`other in multiple directions and at multiple lengths of deployment to
`optimize position.
`
`

`

`o 2015/117025 Al II
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`w
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`11
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`II I
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`1
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`IlllllI
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`I II I II II I II I III II I II
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`Published:
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`— with international search report (Art. 21(3))
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`the time limit for amending the
`before the expiration of
`claims and to be republished in the event of receipt of
`amendments (Rule 48.2(h))
`
`

`

`PIGTAIL FOR OPTIMAL AORTIC VALVULAR COMPLEX IMAGING AND
`
`ALIGNMENT
`
`FIELD OF INVENTION
`
`[0001] This invention relates to devices, systems and methods for aortic valve complex
`
`imaging and/or for transcatheter aortic valve replacement, which may be used to diagnose
`
`and/or treat aortic valve diseases.
`
`BACKGROUND OF THE INVENTION
`
`[0002] All publications cited herein are incorporated by reference in their entirety to the same
`
`extent as if each individual publication or patent application was specifically and individually
`
`indicated to be incorporated by reference. The following description includes information
`
`that may be useful in understanding the present invention.
`
`It is not an admission that any of
`
`the information provided herein is prior art or relevant to the presently claimed invention, or
`
`that any publication specifically or implicitly referenced is prior art.
`
`Prior Transcatheter Valve Therapies
`
`[0003] Valvular heart disease is characterized by damage to or a defect in one of the four
`
`heart valves: the mitral, aortic, tricuspid or pulmonary. The mitral and tricuspid valves
`
`control the flow of blood between the atria and the ventricles (the upper and lower chambers
`
`of the heart). The pulmonary valve controls the blood flow from the heart to the lungs, and
`
`the aortic valve governs blood flow between the heart and the aorta, and thereby to the blood
`
`vessels in the rest of the body. The mitral and aortic valves are the ones most frequently
`
`affected by valvular heart disease. Transcatheter valve therapies are one treatment option for
`
`patients. For example, transcatheter aortic valve replacement (TAVR, also known as TAVI
`
`or transcatheter aortic valve implantation) is a procedure for select patients with severe
`
`symptomatic aortic stenosis (narrowing of the aortic valve opening) who are not candidates
`
`for traditional open chest surgery or are high-risk operable candidates. A replacement valve
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`is inserted percutaneously using a catheter and implanted in the orifice of the native aortic
`
`valve. Replacement valves may be artificial (prosthetic valves) or made from animal tissue
`
`(bioprosthetic valves). The type of replacement valve selected depends on the patient's age,
`
`condition, and the specific valve affected.
`
`[0004] Optimal orientation of X-ray fluoroscopic imaging is fundamental to the success of
`
`

`

`TAVR. An aortic valve has three leaflets: the right coronary leaflet, the left coronary leaflet,
`
`and the non-coronary leaflet. During a TAVR procedure, a conventional pigtail catheter is
`
`normally oriented in the non-coronary leaflet and used to inject a contrast dye for X-ray
`
`imaging. Since dye injection through the pigtail catheter takes place only in the non-coronary
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`leaflet, the other two leaflets depend on dye spilling back and over to be imaged. Hence, this
`
`imaging method is unreliable, and may require multiple injections and large amount of
`
`contrast dye for completely visualizing the aortic root and determining the co-axial plane of
`
`radiographic projection. This imaging method is sometimes supplemented with pre-
`
`procedural imaging such as CT scanning. Reducing the amount of contrast dye used is of
`
`particular benefit to patients on certain drugs or with one or more pre-existing medical
`
`condition, such as diabetes, heart failure or reduced kidney function. Such patients are at a
`
`greater risk of prolonged or permanent damage from the dye, often resulting in the need for
`
`further medical attention or dialysis. A focused and more precise delivery of contrast may
`
`also limit the patient's exposure to radiation.
`
`[0005] Another challenging step during a TAVR procedure is to advance an instrument (e.g.,
`
`a guidewire, a catheter, and/or a pressure sensor) across the aortic valve retrogradely from the
`
`aorta to the left ventricle. This step of retrograde crossing is usually performed with a curved
`
`catheter (for example, an AL1, AL2 or JR4 catheter) and a straight wire, and sometimes
`
`requires considerable manipulation, especially for an aortic valve with a high level of
`
`stenosis. Accordingly, a need exists for an improved system for efficiently orienting a
`
`catheter system with respect to internal vessel and cardiac structures and additionally for
`
`imaging internal vessel and valve structures, for example, the aortic valve.
`
`SUMMARY OF THE INVENTION
`
`[0006] The following embodiments and aspects thereof are described and illustrated in
`
`conjunction with compositions, devices, systems and methods which are meant
`
`to be
`
`exemplary and illustrative, not limiting in scope.
`
`Overview of Invention
`
`[0007] In order to solve the problems discussed above, the applicants have developed a
`
`system of catheters incorporating two, three, or more distal branches that can properly align
`
`and orient a catheter system for either: (1) injecting a contrast dye, (2) imaging an aortic
`
`valve complex or other internal structure (e.g, various blood vessels), and/or (3)
`
`for
`
`

`

`advancing an instrument across an aortic valve or other valvular structures. For example, the
`
`distal branches may form three pigtails that can each engage the base of each of the three
`
`leaflets of an aortic valve. By lining up and engaging each of the three pigtails, clear
`
`visualization of a co-axial radiographic projection can be obtained, even without injection of
`
`a contrast dye, in order to efficiently orient the device for transcatheter aortic valve therapies.
`
`The device also has a central lumen that, when positioned with the three distal branches as
`
`described herein,
`
`is oriented co-axially with the orifice of the aortic valve complex.
`
`Accordingly, once the central lumen and valve orifice are lined up, another instrument such
`
`as a wire can be passed centrally via the central lumen to cross the aortic valve orifice
`
`retrogradely in a more efficient manner. In some embodiments, each of the multiple pigtails
`
`of the device may be advanced independently of one another to optimize position. In some
`
`embodiments, each of the multiple pigtails can be advanced independently, with or without a
`
`guiding wire, to different vessels, chambers, or cavities within or outside the heart or vascular
`
`system, to facilitate focused contrast delivery or drug delivery or sampling of blood or fluid
`
`through their respective central lumens or pressure comparison via their respective central
`
`lumens. In some embodiments, the multiple pigtail device may be of larger profile and may
`
`be used as a delivery sheath designed to facilitate precise device orientation through its
`
`orientation with native anatomy, for example, but not restricted to, delivery of a transcatheter
`
`aortic valve.
`
`Embodiments of Invention
`
`[0008] In various embodiments, provided herein is a device for imaging an aortic valve
`
`complex and/or for advancing an instrument across an aortic valve retrogradely. The device
`
`may include: a catheter comprising an interior wall and an exterior wall, wherein the catheter
`
`has a proximal portion, a distal portion, and a center portion between the proximal portion
`
`and the distal portion. The interior wall forms a central lumen along the longitudinal axis of
`
`the catheter. The interior wall and the exterior wall form a peripheral
`
`lumen around the
`
`central lumen along the longitudinal axis of the catheter. The interior wall and the exterior
`
`wall form three distal branches at the distal portion of the catheter, and the peripheral lumen
`
`branches into three peripheral lumen branches inside the three distal branches. In accordance
`
`with the present invention, each of the three distal branches can comprises one radiographic
`
`marker and/or one or more side openings at or near the distal end of the distal branch.
`
`In
`
`accordance with the present invention, the device further comprises a tube, wherein the tube
`
`is inserted into the central lumen and may be advanced over a guide wire to cross a valve or
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`

`

`stenosis independent from the other components of the device.
`
`[0009] In various embodiments, provided herein is a device for imaging an aortic valve
`
`complex. Various embodiments of the present invention provide a device for imaging an
`
`aortic valve complex. The device may include a catheter comprising a wall, wherein the
`
`catheter has a proximal portion, a distal portion, and a center portion between the proximal
`
`portion and the distal portion. The wall forms one tube along the longitudinal axis of the
`
`catheter at the center portion and forms two, three, four or more distal branches at the distal
`
`portion. Accordingly, the lumen of the tube branches into two, three, four or more lumen
`
`branches inside the two, three, four or more distal branches.
`
`In accordance with the present
`
`invention, each distal branch can comprises one radiographic marker and/or one or more side
`
`openings at or near the distal end of the distal branch.
`
`[0010] In various embodiments, provided herein is a method for imaging an aortic valve
`
`complex. The method may include the following steps: (1) providing an outer sheath; (2)
`
`maneuvering the outer sheath to reach the sinotubular junction of a subject; (3) providing a
`
`device comprising: a catheter comprising an interior wall and an exterior wall, wherein the
`
`catheter has a proximal portion, a distal portion, and a center portion between the proximal
`
`portion and the distal portion, wherein the interior wall forms a central lumen along the
`
`longitudinal axis of the catheter, wherein the interior wall and the exterior wall form a
`
`peripheral lumen around the central lumen along the longitudinal axis of the catheter, wherein
`
`the interior wall and the exterior wall form three distal branches at the distal portion of the
`
`catheter, wherein the peripheral lumen branches into three peripheral lumen branches inside
`
`the three distal branches, and wherein each of the three distal branches comprises one or more
`
`side openings at or near the distal end of the distal branch; (4) inserting the device into the
`
`outer sheath, wherein the three distal branches are straightened inside the outer sheath; (5)
`
`advancing the device of out of the outer sheath, wherein the three distal branches are pigtail-
`
`shaped or J-shaped outside the outer sheath; (6) engaging each of the three aortic leaflets of
`
`the subject with one distal branch; (7) injecting a contrast dye to the aortic valve complex of
`
`the subject through the peripheral lumen; and (8) imaging the aortic valve complex of the
`
`subject.
`
`[0011] In various embodiments, provided herein is a method for imaging an aortic valve
`
`complex. The method may include the following steps: (1) providing an outer sheath; (2)
`
`maneuvering the outer sheath to reach the sinotubular junction of a subject; (3) providing a
`
`

`

`device comprising: a catheter comprising an interior wall and an exterior wall, wherein the
`
`catheter has a proximal portion, a distal portion, and a center portion between the proximal
`
`portion and the distal portion, wherein the interior wall forms a central lumen along the
`
`longitudinal axis of the catheter, wherein the interior wall and the exterior wall form a
`
`peripheral lumen around the central lumen along the longitudinal axis of the catheter, wherein
`
`the interior wall and the exterior wall form three distal branches at the distal portion of the
`
`catheter, wherein the peripheral lumen branches into three peripheral lumen branches inside
`
`the three distal branches, and wherein each of the three distal branches comprises one
`
`radiographic marker at or near the distal end of the distal branch; (4) inserting the device into
`
`the outer sheath, wherein the three distal branches are straightened inside the outer sheath; (5)
`
`advancing the device out of the outer sheath, wherein the three distal branches are pigtail-
`
`shaped or J-shaped outside the outer sheath; (6) engaging each of the three aortic leaflets of
`
`the subject with one distal branch; and (7) imaging the aortic valve complex of the subject
`
`and the radiographic markers.
`
`[0012] In various embodiments, provided herein is a method for imaging an aortic valve
`
`complex. The method may include the following steps: (1) providing an outer sheath; (2)
`
`maneuvering the outer sheath to reach the sinotubular junction or the aortic root just above
`
`the aortic valve of a subject; (3) providing a device comprising: a catheter comprising an
`
`interior wall and an exterior wall, wherein the catheter has a proximal portion, a distal
`
`portion, and a center portion between the proximal portion and the distal portion, wherein the
`
`interior wall forms a central lumen along the longitudinal axis of the catheter, wherein the
`
`interior wall and the exterior wall form a peripheral lumen around the central lumen along the
`
`longitudinal axis of the catheter, wherein the interior wall and the exterior wall form three
`
`distal branches at the distal portion of the catheter, wherein the peripheral lumen branches
`
`into three peripheral lumen branches inside the three distal branches, and wherein each of the
`
`three distal branches comprises one radiographic marker and one or more side openings at or
`
`near the distal end of the distal branch; (4) inserting the device into the outer sheath, wherein
`
`the three distal branches are straightened inside the outer sheath; (5) advancing the device out
`
`of the outer sheath, wherein the three distal branches are pigtail-shaped or J-shaped outside
`
`the outer sheath; (6) engaging each of the three aortic leaflets of the subject with one distal
`
`branch; and (7) imaging the aortic valve complex of the subject and the radiographic markers.
`
`In various embodiments, the method further comprises, prior to step (7), injecting a contrast
`
`dye to the aortic valve complex of the subject through the peripheral lumen.
`
`

`

`[0013] In various embodiments, provided herein is a method for imaging an aortic valve
`
`complex. The method may include the following steps: (1) providing an outer sheath; (2)
`
`maneuvering the outer sheath to reach the sinotubular junction or aortic root, just above the
`
`aortic valve, of a subject; (3) providing a device, comprising: a catheter comprising a wall,
`
`wherein the catheter has a proximal portion, a distal portion, and a center portion between the
`
`proximal portion and the distal portion, wherein the wall
`
`forms one tube along the
`
`longitudinal axis of the catheter at the center portion and forms two, three, four or more distal
`
`branches at the distal portion, wherein the lumen of the tube branches into two, three, four or
`
`more lumen branches inside the two, three, four or more distal branches; (4) inserting the
`
`device into the outer sheath, wherein the two,
`
`three, four or more distal branches are
`
`straightened inside the outer sheath; (5) advancing the device out of the outer sheath, wherein
`
`the two, three, four or more distal branches are pigtail-shaped or J-shaped outside the outer
`
`sheath; (6) engaging each aortic leaflet of the subject with one distal branch; (7) injecting a
`
`contrast dye to the aortic valve complex of the subject through the catheter; and (8) imaging
`
`the aortic valve complex of the subject.
`
`[0014] In an embodiment, the central lumen of the catheter is relatively large (for example, 8-
`
`24 Fr) and acts as a long delivery sheath for a balloon aortic valvuloplasty (BAV) balloon or
`
`TAVR delivery system. In a further embodiment, the device comprises a mechanism (for
`
`example, a radiographic maker) for aligning the ridges, lines, points or alternative markers of
`
`the central lumen and the BAV or TAVR delivery system to facilitate precise rotational
`
`positioning of the BAV or TAVR delivery system in relation to the three native aortic valve
`
`leaflets.
`
`[0015] In another embodiment, in a patient with anatomical variation where the native aortic
`
`valve is bicuspid rather than tricuspid, a device having two rather than three distal branches is
`
`employed in correspondence to the two-leaflet configuration of the native aortic valve with
`
`anatomical variation.
`
`In a further embodiment, the device may be used for the imaging and
`
`correct orientation of other valves.
`
`In accordance with the invention, the number of distal
`
`branches corresponds to the number of leaflets in a native valve of interest. For instance,
`
`when the valve of interest is the mitral valve, which has two leaflets, a device having
`
`correspondingly two distal branches would be employed.
`
`Further Applications of Invention
`
`[0016] In various embodiments, the device may be used to facilitate treatment of any vessel
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`

`

`stenosis that requires a balloon or stent therapy, any aneurysmal vessel that requires a stent
`
`therapy, any vascular sac that requires a vascular closure, including but not limited to the left
`
`atrial appendage.
`
`In some embodiments, each of the pigtails of the device may be advanced
`
`independently of one another to optimize position. In some embodiments, each of the
`
`multiple pigtails can be advanced independently, with or without a guiding wire, to different
`
`vessels to facilitate focused contrast delivery through their respective central
`
`lumens or
`
`pressure comparison via their respective central lumens. In various embodiments, the distal
`
`branches of the device may be used at both cardiac and extracardiac sites to administer
`
`medications, inject contrast dye into a cavity, vessel or structure, drain or sample blood or
`
`fluid or irrigate. Examples of extracardiac applications include, but are not
`
`limited to,
`
`drainage of fluid from the peritoneal space with ascites, injecting contrast dye into the
`
`abdominal cavity, or transurethral irrigation of the bladder in the setting of hematuria.
`
`[0017] In another embodiment, the central shaft formed by the interior lumen of the catheter,
`
`may be advanced over a wire independently of the other layers of the catheter to cross a valve
`
`or stenosis.
`
`[0018] In another embodiment, the double/triple pigtail device has no central lumen and is
`
`simply two/three or more hollow tubes connected to a common hollow tube from which they
`
`branch and is inserted through the outer sheath to the appropriate position. In various
`
`embodiments, the device may not have continuous lumens and may be only used for imaging
`
`without contrast dye.
`
`BRIEF DESCRIPTION OF FIGURES
`
`[0019] Exemplary embodiments are illustrated in the referenced figures.
`
`It is intended that
`
`the embodiments and figures disclosed herein are to be considered illustrative rather than
`
`restrictive.
`
`[0020] FIG. 1 depicts a cross sectional view of an embodiment of a catheter (101), an outer
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`sheath covering the catheter (102), a central lumen inlet (103), a peripheral lumen inlet (104),
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`three distal branches of the catheter (105), an interior wall of the catheter (106), and an
`
`exterior wall of the catheter (107). Panel A-A is a cross-section view of the device at its
`
`proximal end. Panel B-B is a cross-section view of the proximal portion of the device. Panel
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`C-C is a cross-section view of the center portion of the device. Panel D-D is a cross-section
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`view of the distal portion of the device. Panel E-E is a cross-section view of the three distal
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`

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`branches 105 on the distal portion of the device.
`
`[0021] FIGS. 2A-E depict, in accordance with various embodiments of the present invention,
`
`a method of using an exemplar device of the invention for imaging an aortic valve complex.
`
`FIG. 2A depicts a cross sectional view of a patient's heart with an outer sheath 102 being
`
`advanced towards the aortic valve. FIG 2B depicts a cross-sectional view of a patient's heart
`
`with a catheter 101 being advanced distally to the tip of the outer sheath 102. FIG. 2C depicts
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`a cross-sectional view of a patient's heart and the catheter 101 being extended from the outer
`
`sheath 102 and the distal branches extending out towards the aortic valve leaflets. FIG. 2D
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`depicts a cross sectional view of a patient's heart and the distal branches of the catheter 101
`
`including side openings 108 on the distal branches. FIG. 2E depicts a cross sectional view of
`
`a patient's heart a catheter 101, and a guidewire 201.
`
`[0022] FIGS. 3A-D depict, in accordance with various embodiments of the present invention,
`
`a method of using an exemplar device of the invention for imaging an aortic valve complex.
`
`FIG. 3A depicts a cross sectional view of a patient's heart with an outer sheath 102 being
`
`advanced towards the aortic valve. FIG 3B depicts a cross-sectional view of a patient's heart
`
`with a catheter 101 being advanced distally to the tip of the outer sheath 102. FIG. 3C depicts
`
`a cross-sectional view of a patient's heart and the catheter 101 being extended from the outer
`
`sheath 102 and the distal branches extending out towards the aortic valve leaflets. FIG. 3D
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`depicts a cross sectional view of a patient's heart and the distal branches of the catheter 101
`
`including radiographic markers 109 on the distal branches.
`
`[0023] FIGS. 4A-C depict, in accordance with various embodiments of the present invention,
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`three non-limiting examples of the distal branch with side openings 108 and/or radiographic
`
`markers 109. FIG. 4A depicts a cross section of a distal branch with side openings 108. FIG.
`
`4B depicts a cross section of a distal branch with a radiographic marker 109. FIG. 4C depicts
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`a cross section of a distal branch with a radiographic marker 109 and a side opening 108.
`
`[0024] FIG. 5 depicts, depicts a longitudinal cross sectional view of an embodiment of a
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`catheter (501), an outer sheath covering the catheter (502), a wall of the catheter (503), an
`
`inlet (504), and three distal branches of the catheter (505). Panel A-A is a cross-section view
`
`of the device at its proximal end. Panel B-B is a cross-section view of the proximal portion
`
`of the device. Panel C-C is a cross-section view of the center portion of the device. Panel D-
`
`D is a cross-section view of the distal portion of the device. Panel E-E is a cross-section view
`
`of the three distal branches 505 on the distal portion of the device. Along the longitudinal
`
`

`

`axis of the catheter (501), the wall (503) forms one tube at the center portion and forms three
`
`distal branches (505) at the distal portion. Accordingly, the lumen of the tube branches into
`
`three lumen branches inside the two, three, four or more distal branches. At or near its distal
`
`end, the distal branch can comprise one or more side openings, one radiographic marker, or
`
`both (see FIGS. 4A-C).
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`[0025] The applicants have developed a system of catheters incorporating two, three, or more
`
`distal branches that can properly align and orient a catheter system for either: (1) injecting a
`
`contrast dye or drug, (2) draining or sampling blood or fluid, (3) imaging an aortic valve
`
`complex or other internal structures (e.g. vessels),
`
`(4) calculating pressure differences
`
`between the branches or cavities, (5) for advancing an instrument across an aortic valve, other
`
`valve, or other internal structures. For example, the three distal branches may form or end in
`
`three pigtails that can each be navigated to the one of the three aortic valve leaflets in order to
`
`engage the base of each of the three leaflets . By lining up the three distal branches with the
`
`base of the leaflets, the device will be efficiently oriented to (1) inject contrast dye to
`
`visualize the leaflets and/or (2) visualize the valvular complex using radiographic markers
`
`inside the distal branches,
`
`[0026] The device may also have a central lumen that is oriented co-axially with the orifice
`
`of the aortic valve complex, when the distal branches are appropriately positioned by
`
`engaging or contacting the base of the leaflets of a valve complex. Accordingly, once the
`
`central lumen and valve orifice are lined up, another instrument such as a wire can be passed
`
`centrally via the central lumen to cross the aortic valve orifice retrogradely in a more efficient
`
`manner.
`
`[0027]
`
`In some embodiments, each of the multiple pigtails of the device may be advanced
`
`independently of one another to optimize position. This may allow a caregiver to optimally
`
`position each of the branches independently, in order to allow the device to accommodate a
`
`wider range of variability in physiology and different types of physiological structures. In
`
`these embodiments, the lumens and sidewall of the distal branches may slide with respect to
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`the central lumen. In some embodiments, this will allow the distal branches to telescope from
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`the central lumen and rotate to optimally orient the device. In some embodiments, each of the
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`multiple pigtails can be advanced independently, with or without a guiding wire, to different
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`vessels, chambers, or cavities within or outside the heart or vascular system, to facilitate
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`focused contrast delivery or drug delivery through their respective central lumens or pressure
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`comparison via their respective central lumens. In some embodiments, the multiple pigtail
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`device may be of larger profile and may be used as a delivery sheath designed to facilitate
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`precise device orientation through its orientation with native anatomy, for example, but not
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`restricted to, delivery of a transcatheter aortic valve.
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`EXAMPLES
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`[0028] The following examples are provided to better illustrate the claimed invention and are
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`not to be interpreted as limiting the scope of the invention. To the extent that specific
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`materials are mentioned, it is merely for purposes of illustration and is not intended to limit
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`the invention. One skilled in the art may develop equivalent means or reactants without the
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`exercise of inventive capacity and without departing from the scope of the invention.
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`Example 1
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`[0029] A non-limiting example of a device according to the present disclosure is shown in
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`FIG. 1. The catheter 101 is covered by an outer sheath 102. The length of the catheter 101
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`may be but is not limited to about 90-300 cm depending on the precise application. The
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`diameter of the catheter may be but is not limited to about 4-23 Fr. The length of the outer
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`sheath 102 may be but is not limited to about 80-290 cm. The diameter of the outer sheath
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`102 may be but is not limited to about 5-24 Fr. The catheter 101 may have an interior wall
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`106 and an exterior wall 107.
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`In some embodiments, a central lumen is defined by the
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`interior wall 106 at the center of the catheter 101. The central lumen may be used for
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`inserting another instrument (e.g., a guidewire, a catheter, and a pressure sensor). For
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`example, the catheter 101 may be advanced over a guidewire in the central lumen to be
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`guided to reach the sinotubular junction or other internal structure, or a guidewire may be
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`inserted in the central lumen to be guided through an aortic valve orifice or other orifice that
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`is co-axially aligned with the central lumen. Around the central lumen, a peripheral lumen
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`may be formed between the interior wall 106 and the exterior wall 107.
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`In other
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`embodiments, the peripheral lumen may be formed by a separate tube and wall that may be
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`able to move relative to the central lumen. This will allow the peripheral
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`lumens (and
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`therefore the distal branches 105) to be separately and independently extended and rotated
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`with respect to the central lumen and each other. This may allow for optimal positioning of
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`the distal branches 105. The peripheral lumen(s) may be used as a contrast dye reservoir for
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`filling a contrast dye and/or as a fluid commutation channel for injecting a contrast dye or
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`drug. For instance and as described below, the peripheral lumen may branch into two lumens,
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`three lumens, four lumens, five lumens, six lumens, or other amount of lumens in the distal
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`branches of the catheter 101 and allow the contrast dye to flow down the peripheral lumen
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`into the distal branches 105 and out of the side openings of the distal branches. The diameter
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`of the tubular interior wall may be but is not limited to about 1-6 Fr. The diameter of the
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`tubular exterior wall may be but is not limited to about 2-8 Fr.
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`[0030] The catheter 101 has a proximal portion (close to a user, shown at the top), where the
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`central
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`lumen and the peripheral
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`lumen each form two separate inlets 103 and 104. As
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`described above, these may be formed by two separate, non-coaxial tubes, or coaxial tubes
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`with an interior wall 106 and an exterior wall 107. The central lumen inlet 103 may be used
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`for inserting another instrument (e.g., a guidewire, a catheter, and a pressure sensor). The
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`peripheral lumen inlet 104 may be used for filling and/or injecting a contrast dye.
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`[0031] The catheter 101 may have a distal portion (away from a user, shown at the bottom),
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`where, in some embodiments,
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`the catheter 101 branches into two, three, four, five, six, or
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`more distal branches 105 and the peripheral
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`lumen accordingly branches into as many
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`peripheral lumen branches inside the distal branches 105. The length of the distal branches
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`105 may be but is not limited to about 2-20 cm. The diameter of the distal branches 105 may
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`be but is not limited to about 1-6 Fr.
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`[0032] In some embodiments, at or near the end of each distal branch 105, there are one or
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`more side openings 108. Side openings 108 may be any suitable openings in the distal
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`branches 105 of the catheter 108 that allow the contrast dye to flow out from the peripheral
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`lumen into the heart. In some embodiments, side openings 108 may be a plethora of tiny
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`openings to allow more even dispersal of the contrast dye