(12) United States Patent
`Chen
`
`USOO6860876B2
`(10) Patent No.:
`US 6,860,876 B2
`(45) Date of Patent:
`Mar. 1, 2005
`
`(54) VERSATILE INTERVENTIONAL CORONARY
`GUIDING CATHETER
`
`(76) Inventor: Jack P. Chen, 720 Aran Dr., Roswell,
`GA (US) 30076
`
`(*) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl. No.: 10/434,545
`(22) Filed:
`May 9, 2003
`(65)
`Prior Publication Data
`
`US 2004/0225297 A1 Nov. 11, 2004
`(51) Int. Cl." ............................................... A61M 25/01
`(52) U.S. Cl. ....................... 604/528; 604/534; 604/508;
`604/510
`(58) Field of Search ......................... 606/108; 600/435;
`604/523, 528, 532–535, 508, 510, 103.04,
`103.05, 16408, 171
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`5,098.412 A 3/1992 Shiu
`
`5,540,659 A * 7/1996 Teirstein ..................... 604/104
`2003/0109852 A1
`6/2003 Peterson et al.
`2003/O130598 A1
`7/2003 Manning et al.
`* cited by examiner
`Primary Examiner Nicholas D. Lucchesi
`ASSistant Examiner Kevin C. Sirmons
`(74) Attorney, Agent, or Firm-Sutherland Asbill &
`Brennan LLP
`
`ABSTRACT
`(57)
`A versatile coronary guiding catheter device and methods of
`use are provided. The device includes a guiding catheter, an
`anchor Shaft, and a sleeve. In one embodiment, the anchor
`shaft can be moved relative to the catheter body to form a
`loop defined by the portions of the anchor shaft and catheter
`body that are between the distal end of the sleeve and a hinge
`point. The loop engages an interior Surface of the aorta in
`manner effective to facilitate insertion of the distal end of the
`catheter body into a coronary ostium, to provide backup
`Support for maintaining a position of the distal end of the
`catheter body within a coronary ostium, or both. The sleeve
`may also be moveable to increase the control of the loop size
`and position, to facilitate greater control of the placement of
`the catheter tip.
`
`23 Claims, 11 Drawing Sheets
`
`o
`
`
`
`Page 1
`
`Medtronic Exhibit 1859
`
`

`

`U.S. Patent
`
`Mar. 1, 2005
`
`Sheet 1 of 11
`
`US 6,860,876 B2
`
`
`
`Page 2
`
`Medtronic Exhibit 1859
`
`

`

`U.S. Patent
`
`Mar. 1, 2005
`
`Sheet 2 of 11
`
`US 6,860,876 B2
`
`
`
`Page 3
`
`Medtronic Exhibit 1859
`
`

`

`U.S. Patent
`
`Mar. 1, 2005
`
`Sheet 3 of 11
`
`US 6,860,876 B2
`
`
`
`Page 4
`
`Medtronic Exhibit 1859
`
`

`

`U.S. Patent
`
`Mar. 1, 2005
`
`Sheet 4 of 11
`
`US 6,860,876 B2
`
`
`
`:
`
`Page 5
`
`Medtronic Exhibit 1859
`
`

`

`U.S. Patent
`
`Mar. 1, 2005
`
`Sheet 5 of 11
`
`US 6,860,876 B2
`
`a CR
`
`O
`CN
`
`2S
`
`se
`
`s 3
`
`N so
`
`
`
`Page 6
`
`Medtronic Exhibit 1859
`
`

`

`U.S. Patent
`
`Mar. 1, 2005
`
`Sheet 6 of 11
`
`US 6,860,876 B2
`
`
`
`Page 7
`
`Medtronic Exhibit 1859
`
`

`

`U.S. Patent
`
`Mar. 1, 2005
`
`Sheet 7 of 11
`
`US 6,860,876 B2
`
`
`
`:
`
`:
`
`Page 8
`
`Medtronic Exhibit 1859
`
`

`

`U.S. Patent
`
`Mar. 1, 2005
`
`Sheet 8 of 11
`
`US 6,860,876 B2
`
`
`
`Page 9
`
`Medtronic Exhibit 1859
`
`

`

`U.S. Patent
`
`Mar. 1, 2005
`
`Sheet 9 of 11
`
`US 6,860,876 B2
`
`
`
`W O
`
`O
`Q
`
`Page 10
`
`Medtronic Exhibit 1859
`
`

`

`U.S. Patent
`
`Mar. 1, 2005
`
`Sheet 10 of 11
`
`US 6,860,876 B2
`
`
`
`Page 11
`
`Medtronic Exhibit 1859
`
`

`

`U.S. Patent
`
`Mar. 1, 2005
`
`Sheet 11 of 11
`
`US 6,860,876 B2
`
`
`
`S.
`
`s
`
`Page 12
`
`Medtronic Exhibit 1859
`
`

`

`1
`VERSATILE INTERVENTIONAL CORONARY
`GUIDING CATHETER
`
`BACKGROUND OF THE INVENTION
`This invention is generally in the field of medical devices,
`and more particularly catheters for use in interventional
`cardiology.
`Catheters are often used in the performance of medical
`procedures Such as coronary angiography for injecting dye,
`or the like, into the cardiovascular System for diagnosis, and
`angioplasty to widen the lumen of a coronary artery which
`has become at least partially blocked by a Stenotic lesion
`causing an abnormal narrowing of the artery due to injury or
`disease.
`Interventional cardiology is a medical Subspecialty in
`which a guiding catheter is used to insert balloons, Stents,
`and other therapeutic devices (e.g., laser catheters, atherec
`tomy catheters) into arteries Supplying blood to the heart
`muscle, i.e., coronary arteries, to open fatty blockages, e.g.,
`percutaneous transluminal coronary angioplasty. These
`devices move through an axial lumen in the catheter.
`Generally, a catheter is inserted into an artery in the groin or
`wrist of the patient and advanced into the aorta. The tip, or
`distal end, of the catheter then is inserted into the ostium (the
`opening) of a coronary artery, one of three Small vessels
`branching off the aortic root (the base of the aorta) around
`the heart. The opposite, or proximal, end of the guiding
`catheter, through which balloons Stents or other devices are
`introduced and advanced into the lumen of the guiding
`catheter, remains outside of the patient's body. The balloon
`or other device is advanced through the lumen of the
`catheter, out an aperture in the tip, and into the coronary
`artery to the blockage.
`Varying degrees of resistance to balloon advancement are
`encountered, depending upon Several factors, Such as
`tortuosity, calcification (or stiffness), and size of the coro
`nary artery. This resistance translates into an equal and
`opposite force onto the guiding catheter, which undesirably
`tends to back the guiding catheter out of the coronary
`ostium. The force or Support with which a particular catheter
`can exert to oppose this retreat and maintain the position of
`the tip within the vessel ostium determines the catheter's
`ability to allow passage of balloons or other devices, for a
`Successful interventional procedure.
`There are varying catheter design approaches for dealing
`with this advancement resistance. For example, a catheter
`design may be based upon the curvature of the catheter tip,
`as well as on the thickness and stiffness of the wall of the
`catheter. "Aggressive” catheter designs, Such as Amplaz or
`Voda type, provide for “deep seating” of the tip further into
`the vessel and afford greater maintenance of tip position
`“backup support” while advancing the balloon. The disad
`Vantage of these catheters, however, is an increased risk of
`vessel trauma or dissection, as the tip is forcefully engaged
`in the vessel ostium. Conversely, “conservative” catheter
`designs, Such as Judkins, are more flexible and insert only
`minimally, atraumatically, into the coronary ostium. The
`drawback of this design, however, is that it offers leSS
`backup Support and consequently increases the potential
`failure to deliver the balloon or other device to the target
`blockage. In addition to backup Support, the locations of the
`coronary arteries are extremely variable among patients,
`necessitating multiple curvature designs to accommodate
`the wide array of anatomical variations.
`Therefore, the Selection of catheter is a critical part of an
`interventional procedure. Oftentimes, multiple different
`
`15
`
`25
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`US 6,860,876 B2
`
`2
`catheters need to be tried before an appropriate one is
`identified. Such multiple catheter exchanges can jeopardize
`patient Safety, frustrate the physician, increase the cost of the
`procedure, and increase the cost of providing the inventory
`of catheters. At times, the physician may have to accept a
`Suboptimal result because a Superior, but bulkier, device
`Such as a Stent is not deliverable without adequate guiding
`catheter backup Support. It would be desirable to take Some
`of the "guesswork out of guiding catheter Selection, both
`for considerations of backup Support as well as anatomic
`variations. It would be desirable to provide a single, Versatile
`catheter, combining favorably features of aggressive designs
`and conservative designs as needed.
`U.S. Pat. No. 5,098,412 to Shiu discloses a support
`System for a guiding catheter. The catheter comprises a main
`lumen and a Secondary lumen, which are connected inte
`grally together throughout the proximal portion of the length
`of the catheter but are separated throughout a distal portion.
`An incompressible, flexible, elongate element is slidably
`disposed within the Secondary lumen and is anchored at the
`distal end of the catheter. The proximal end of the catheter
`includes operating means to exert an endwise force on the
`elongate element to cause the Separated portion of the
`Secondary lumen to move away from the main lumen to
`brace the catheter against opposite walls of the aorta for
`“backup' Support and to retain it in a Selected position. This
`design, however, requires two full lumens, each having its
`own wall Structure all the way around the lumen perimeter.
`This feature results in a double layer of sleeve material
`where the sleeves of the two lumens interface, adding
`thickness to the catheter device, causing it to have a larger
`profile without a corresponding increase in lumen diameter,
`even though it is highly desirable to maximize the ratio of
`the inside diameter of any functional lumen to the outside
`diameter of the tubular body in coronary arterial applica
`tions. That is, for a given lumen diameter sized to accom
`modate a particular balloon or other therapeutic device, the
`catheter desirably has as Small a profile, or sheath size, as
`possible in order to minimize arterial trauma (e.g., trauma to
`the femoral artery). In another aspect, it would be desirable
`to provide means for more finely controlling the position of
`the backup Support member, the position of the distal tip of
`the primary catheter, or both, in order to enhance the
`Versatility of a Single catheter design.
`SUMMARY OF THE INVENTION
`Versatile guiding catheter devices and methods of use are
`provided.
`In one aspect, the device includes an extension catheter.
`For example, in a preferred embodiment, the device includes
`(i) an elongated, flexible, tubular catheter body having a
`proximal end, a distal end, and a central lumen extending
`therebetween; (ii) an elongated, flexible sleeve having a
`proximal end and a distal end, the sleeve being Secured to
`and covering at least a portion of the outer, greater curvature
`of the catheter body So as to define a Secondary lumen
`between the sleeve and an outer Surface area of the catheter
`body, and the distal end of the sleeve being in a position
`proximal the distal end of the catheter body; and (iii) an
`anchor Shaft having a proximal end and a distal end, the
`anchor Shaft extending through the Secondary lumen, the
`distal end being fixedly attached to the catheter body at an
`outer surface area between the distal end of the catheter body
`and the distal end of the sleeve to form a hinge point about
`which the distal portion of the anchor shaft can rotate with
`respect to the catheter body, wherein the proximal end of the
`anchor shaft can be reversibly advanced (preferably
`
`Page 13
`
`Medtronic Exhibit 1859
`
`

`

`3
`manually) toward the distal ends of the anchor shaft and
`catheter body to cause the distal end portion of the anchor
`shaft to bow away from the catheter body in the region
`between the hinge point and the distal end of the sleeve,
`forming a loop which is defined by the portions of the anchor
`shaft and catheter body that are between the distal end of the
`sleeve and the hinge point.
`In another aspect, the guiding catheter device includes a
`retraction anchor Shaft, alone or in combination with the
`extension anchor Shaft described above. In a preferred
`embodiment, the versatile guiding catheter device includes
`(i) a catheter body as described above; (ii) a sleeve and
`Secondary lumen as described above, except attached at the
`inner, lesser curvature of the catheter body; and (iii) an
`anchor Shaft and hinge point as described above, but which
`is adapted So that the proximal end of the anchor Shaft can
`be reversibly retracted (preferably manually) away from the
`sleeve to cause the distal end of the anchor Shaft to move
`toward the sleeve, decreasing the radius of curvature of the
`distal end portion of the catheter body that is between the
`distal end of the sleeve and the hinge point.
`In one embodiment of the device with either a retraction
`or extension anchor Shaft, the Sleeve is moveably Secured to
`the catheter body, so that the sleeve can be reversibly
`advanced (preferably manually) toward the proximal ends of
`the anchor shaft and catheter body. In a variation of this
`embodiment, the proximal end portion of the moveable
`sleeve comprises a locking means for Securing the sleeve in
`one or more positions along the catheter body.
`Optionally, the proximal end portion of the anchor Shaft,
`either extension or retraction, comprises a locking means for
`Securing the anchor Shaft at one or more positions along the
`catheter body.
`The distal end portion of the catheter body is curved. For
`the extension anchor Shaft, the hinge point preferably is
`located on the Outer curvature of the curved distal end
`portion of the catheter body. For the retraction anchor shaft,
`the hinge point preferably is located on the inner curvature
`of the curved distal end portion of the catheter body.
`In yet another aspect, methods are provided for using
`these versatile guiding catheter devices to accurately guide
`a catheter into a coronary artery for coronary intervention.
`The methods comprise inserting into the aorta of a patient in
`need of coronary intervention the distal ends of the catheter
`body, sleeve, and anchor Shaft, with the distal end portion of
`the anchor shaft in a resting position adjacent the catheter
`body.
`For the extension anchor shaft, the method further
`includes advancing (preferably manually) the proximal end
`of the anchor shaft toward the distal ends of the anchor shaft
`and catheter body to cause the distal end portion of the
`anchor shaft to bow away from the catheter body in the
`region between the hinge point and the distal end of the
`sleeve, forming a loop which is defined by the portions of the
`anchor shaft and catheter body that are between the distal
`end of the Sleeve and the hinge point, and then adjusting the
`position of the proximal end of the anchor Shaft to cause the
`loop to engage the opposing wall in the interior Surface of
`the aorta in manner effective to facilitate insertion of the
`distal end of the catheter body into a coronary ostium, to
`provide backup Support for maintaining a position of the
`distal end of the catheter body within a coronary ostium, or
`both. For the retraction anchor shaft, the method further
`includes retracting the proximal end of the anchor shaft
`away from the sleeve to cause the distal end of the anchor
`shaft to move toward the sleeve, decreasing the radius of
`
`15
`
`25
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`US 6,860,876 B2
`
`4
`curvature of the distal end portion of the catheter body that
`is between the distal end of the sleeve and the hinge point,
`and then adjusting the position of the proximal end of the
`anchor shaft to facilitate insertion of the distal end of the
`catheter body into a coronary ostium. If the sleeve is
`moveable, then the method can further include retracting the
`sleeve toward the proximal ends of the anchor Shaft and
`catheter body to enlarge the loop or fine-tune the radius of
`curvature of the distal end portion of the catheter body.
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a perspective view of one embodiment of a
`catheter device with an extension anchor Shaft in a resting
`position.
`FIG. 2 is a perspective view of the catheter device of FIG.
`1 with the anchor Shaft in an extended position.
`FIG. 3 is a cross-sectional view of the midsection of the
`catheter device of FIGS. 1 and 2.
`FIG. 4 is a perspective view of one embodiment of a
`catheter device with an extension anchor Shaft in a resting
`position and with a moveable Sleeve.
`FIG. 5 is a cross-sectional view of the midsection of the
`catheter device of FIG. 4.
`FIG. 6 is a perspective view of one embodiment of a
`catheter device with a retraction anchor Shaft in a resting
`position.
`FIG. 7 is a perspective view of the catheter device of FIG.
`6 with the anchor Shaft in a retracted position.
`FIGS. 8A-C illustrate use of one embodiment of a cath
`eter device with an extension anchor shaft, shown located
`for use within an aorta in a resting position (FIG. 8A), in a
`mid-extension position (FIG. 8B), and in a full-extension
`position (FIG. 8C).
`FIGS. 9A-C illustrate use of one embodiment of a cath
`eter device with an extension anchor shaft and moveable
`sleeve. FIG. 9A depicts a resting configuration with Subop
`timal fitting of an unusual coronary location shown with the
`moveable sleeve in a distal position, and FIGS. 9B-C
`illustrate progressive distal eXtension of the anchor Shaft
`with Simultaneous proximal retraction of the moveable
`sleeve for optimal coronary engagement.
`FIGS. 10A-B illustrate use of one embodiment of a
`catheter device with a retraction anchor shaft, shown located
`for use within an aorta in a resting position (FIG. 10A) and
`in a retracted position (FIG. 10B).
`FIGS. 11A-D illustrate various non-limiting embodi
`ments of locking mechanisms for Securing the anchor Shaft
`position along the catheter body. FIGS. 11 A-C depict cross
`sectional side views, and FIG. 11D depicts a top view of the
`anchor shaft shown in FIGS. 11B-C.
`FIG. 12 is a perspective view of one embodiment of a
`guiding catheter device with both an extension anchor Shaft
`and a retraction anchor shaft.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`An improved, versatile coronary guiding catheter device
`has been developed. Advantageously, the catheter device
`described herein can reduce the criticality of guider
`Selection, as the catheter is versatile and adaptable to a
`variety of arterial sizes and shapes. It can beneficially reduce
`or eliminate the need for awkward and potentially dangerous
`mid-procedure exchanges of the guiding catheter.
`The catheter device includes a guiding catheter, an anchor
`shaft, and a sleeve. Advantageously, the present device
`
`Page 14
`
`Medtronic Exhibit 1859
`
`

`

`S
`enables the catheter design to have relatively thinner wall
`Structure, compared to conventional catheter designs,
`because the stiffness of the catheter body becomes less
`critical due to backup Support being provided by the anchor
`shaft. In addition, the present catheter device advanta
`geously removes Some of the guesswork out of the Selection
`of the guiding catheter, both for considerations of backup
`Support and anatomic variations. The resistance to advance
`ment of hardware (e.g., balloons, Stents, or atherectomy
`devices) into the coronary artery, and hence need for
`“aggressive' guide catheter engagement, often cannot be
`predicted a priori during initial catheter Selection at the
`beginning of an interventional procedure. The dynamic
`nature of the present catheter design allows for fine-tuning
`of the degree of Ostial engagement (with its attendant
`potential for arterial trauma or dissection) as hardware is
`Simultaneously advanced into the coronary. In addition, the
`duration of deep catheter engagement advantageously is
`minimized, as the catheter can assume resting position
`during most of the procedure (i.e., before and after actual
`hardware advancement, in contrast to a Static aggressive
`catheter, with prolonged arterial trauma throughout the
`duration of the entire procedure. Instead of having to choose
`the perfect catheter for a particular patient and Situation, the
`present catheter device can be readily adapted to the Situa
`tion during the procedure.
`The catheter device can be further understood with ref
`erence to the exemplary embodiments illustrated in FIGS.
`1-10.
`A preferred embodiment of the versatile catheter device is
`illustrated FIGS. 1-3. The catheter device 10 includes a
`guiding catheter 12, an anchor Shaft 14, and a sleeve 16. In
`this embodiment, the anchor shaft may be referred to herein
`as an extension anchor Shaft, because the physician holding
`the proximal end of the anchor shaft extends it distally from
`its resting position in order to engage its Support function.
`The guiding catheter 12 comprises an elongated, flexible,
`tubular catheter body 18 having a proximal end, a distal end,
`and a central lumen extending therebetween. The catheter
`body includes a distal end portion 22 extending from the
`distal (tip) end of the catheter body to a location spaced
`proximally from the tip and a proximal end portion 20
`extending proximally from the proximal end of the distal
`end portion. The distal end portion 22 preferably is variably
`curved. The catheter body 18 includes a wall structure 24
`defining the central lumen 26. The catheter body 18 is
`formed by conventional means from biologically compatible
`Synthetic polymers.
`In a preferred embodiment, the anchor Shaft 14 comprises
`an elongated, incompressible, Semi-rigid ribbon, which
`approximately spans the length of the guiding catheter body
`18, adjacent the outer Surface of and Substantially parallel to
`the catheter body. The anchor shaft 14 has a proximal end
`portion 30 and a distal end portion 32, which is attached to
`the outer Surface of the catheter body 18 at a position
`proximal a short distance (e.g., between about 1 and about
`5 cm) from the tip of the catheter body. The area at which
`the anchor Shaft is attached to the guiding catheter is referred
`to herein as the “hinge point 34, because the anchor shaft
`and guiding catheter can at least partially move, e.g., rotate,
`relative to each other about this point. The anchor shaft is
`formed by conventional means from biologically compatible
`Synthetic polymers, metals, or a combination thereof. The
`anchor shaft preferably is made of a semi-soft material (e.g.,
`TEFLONTM) and preferably has a width between about 20%
`and about 25% of the circumference of the catheter body 18.
`In a preferred embodiment, the sleeve 16 is a thin,
`elongated, flexible covering over at least a portion of the
`
`15
`
`25
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`US 6,860,876 B2
`
`6
`catheter body 18, forming a secondary lumen 15 between the
`sleeve 16 and a longitudinal area along the outer Surface of
`wall 24 of the catheter body 18. See FIG. 3. The sleeve 16
`extends from near the proximal end of the catheter body 18
`and terminates a short distance proximal the hinge point 34.
`The anchor shaft 14 is slidably positioned in the secondary
`lumen 15. The proximal end of the anchor shaft extends
`proximally beyond the proximal end of the sleeve and
`terminating into or at an anchor locking means 36, which
`Secures the adjusted position of the anchor Shaft 14 relative
`to the catheter body 18. The sleeve 16 can be very thin and
`made of essentially any flexible material; it need only be
`Strong enough to contain outward forces exerted by exten
`Sion of the anchor Shaft to Separate the sleeve from the
`catheter body. The sleeve 16 preferably is formed by con
`ventional means from biologically compatible Synthetic
`polymers. It may be formed integrally with the catheter
`body, or formed Separately and then attached thereto. The
`optional locking means could be essentially any type of
`mechanism for Securing the anchor Shaft position relative to
`the catheter body position. For instance, the locking means
`could include one or more of the following non-limiting
`examples: hook-and-loop fasteners such as VELCROTM,
`notch mechanisms, button-hole mechanisms, releasably
`attachable preSSure Sensitive adhesive materials, Snaps,
`clips, clamps and combinations thereof. See, for example,
`FIGS. 11A-D, which illustrate some possible embodiments
`of such locking means. FIG. 11A shows proximal end 20 of
`catheter body with proximal end 30 of anchor shaft secured
`together with locking means 36, which is in the form of a
`hook-and-loop fastener 82, which would typically consist of
`a hook (or loop) portion fixed onto an outer Surface of the
`proximal end 20 and a loop (or hook) portion fixed onto an
`interfacing portion of the proximal end 30. FIG. 11B illus
`trates locking means 36, which is in the form of notches 84
`designed to Secure the anchor Shaft at variable positions
`along the catheter body. FIG. 11C illustrates locking means
`36, which is in the form of buttons/holes 86 designed to
`Secure the anchor Shaft at variable positions along the
`catheter body. FIG. 11D is a top view of FIGS. 11B and 11C,
`and shows the fenestrated proximal anchor Shaft which
`comprises part of locking means 36. Five fenestrations (e.g.,
`button holes) are shown within the width of the anchor shaft;
`however, more or less than five fenestrations (e.g., 3, 4, 6,
`etc.) could be employed.
`In operation, the anchor locking means 36 is disengaged
`and then the proximal end portion 30 of the anchor shaft 14
`is advanced distally along the Secondary lumen 15 defined
`between the sleeve 16 and a longitudinal area along the outer
`surface of wall 24 of the catheter body 18. This advancement
`causes the distal end portion 32 of the anchor shaft 14, as it
`exits from the secondary lumen 15, to bow or flex away from
`the catheter body 18 in the region between the hinge point
`34 and the distal end 35 of the sleeve, forming a loop 40,
`which is defined by the distal portion of the anchor shaft that
`is distal the distal end of the Secondary lumen, and the distal
`portion of the catheter body that is distal the distal end of the
`secondary lumen. See FIG. 2.
`The size or diameter of this loop 40 is controlled by the
`advancement or retraction of the anchor shaft 14 relative to
`the catheter body 18. The loop size or diameter determines
`the degree of backup Support provided during use, e.g.,
`coronary intervention. See FIGS. 8A-C, which shows this
`embodiment positioned within aorta 100 with distal end of
`catheter body being directed into the coronary ostium 102.
`The catheter tip can be forced into the coronary ostium as the
`loop Size is enlarged. AS the loop is enlarged, it can Sequen
`
`Page 15
`
`Medtronic Exhibit 1859
`
`

`

`7
`tially abut the contralateral cusp 104 (e.g., a mid- or
`moderate-extension position-FIG. 8B, like an EBU- or
`XB-type catheter), offering moderate Support, and then abut
`the contralateral wall 106 (e.g., a full-extension position
`FIG. 8C, like an Amplatz- or Voda-type catheter), offering
`greater Support. In this way, a single design catheter device
`can be used to Successfully negotiate a relatively narrow or
`relatively wide aortic root diameter with equal precision,
`because the anchor Shaft position can be adjusted to conform
`the catheter as needed to fit a variety of coronary locations
`and aortic root widths.
`The guiding catheter devices described herein allow for
`universal application to virtually all coronary interventions.
`With the anchor Shaft retracted, the device assumes a con
`Servative or Zero (i.e., initial resting) configuration, which
`approximates the design of a Judkins catheter. AS the anchor
`shaft is progressively advanced, if and as needed, gradually
`increasing degrees of backup Support are at the physician's
`disposal via anchor Shaft advancement and transformation
`into the extended configurations. For example, in an inter
`mediate embodiment, the curve of the distal portion of the
`catheter body resembles that of an EBU or XB catheter (for
`contralateral cusp abutment). In another example, in a fully
`extended or aggressive configuration, the curve of the distal
`portion of the catheter body resembles that of an Amplatz
`or Voda-like Support (for contralateral wall abutment).
`The sleeve may also be moveable to increase the control
`of the loop size and position, to facilitate greater control of
`the placement of the catheter tip. FIGS. 4, 5 and 9 illustrate
`one Such catheter device. It includes a moveable sleeve,
`which can be advanced or retracted along the catheter body
`to provide additional operational versatility. This feature
`allows the physician to further vary the size of the loop, as
`well as its position along the catheter body, to fine tune the
`orientation and backup Support for the distal tip of the
`catheter.
`As shown in FIGS. 4 and 5, catheter device 50 includes
`moveable sleeve 56. The catheter body 18 and anchor shaft
`14 are substantially the same as in device 10; however,
`sleeve 56 extends completely around the diameter of the
`catheter body 18, so that the sleeve 56 can be slidably moved
`along the catheter body 18. In an alternative embodiment,
`not shown in the Figures, the moveable sleeve does not
`extend completely around the catheter body; rather it would
`cover only a portion of the diameter of, and be in Slideable
`engagement with, the catheter body. The moveable sleeve
`can include a locking mechanism (not shown) for releasably
`Securing the Sleeve in different positions as desired by the
`physician.
`In device 50, the locking and adjustment of the anchor
`shaft can be operated in an essentially identical manner as in
`device 10. However, additional control of loop 40 is afforded
`by adjusting the position of the moveable sleeve 56. FIG. 9A
`shows the device in the resting or unengaged position, with
`a Suboptimal distal catheter curve, unable to intubate the
`relatively Superior location of an unusually located coronary
`ostium 102. FIG. 9B shows the loop 40 abutting the con
`tralateral cusp of aorta 100 with sleeve 56 positioned
`towards the distal end portion 22 of the catheter body 18.
`The catheter curve is tightened, allowing for coronary
`engagement. To increase the Support, sleeve 56 can be
`moved toward the proximal end of the catheter body 18, to
`expose more of the distal portion 32 of the anchor shaft 14
`and thus to enlarge the size of the loop 40. As shown in FIG.
`9C, this movement causes the loop 40 to abut the contralat
`eral wall and further enhance Support for the catheter tip
`portion 22, driving it deeper into the coronary Ostium 102.
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`US 6,860,876 B2
`
`15
`
`25
`
`8
`A further useful embodiment is illustrated in FIGS. 6, 7,
`and 10. This catheter device includes an anchor shaft on the
`opposite side (inner curvature) of the catheter body to
`tighten the tip curvature as needed to allow fine manipula
`tions for optimal coronary engagement, especially in
`unusual coronary locations.
`As shown in FIGS. 6 and 7, the catheter device 60
`includes catheter body 18, sleeve 16, and an anchor shaft 62
`wherein the hinge point 64 is on the inner curvature of the
`distal portion 22 of the catheter body 18. (This is in contrast
`to device 10, where the hinge point is on the outer
`curvature.) The anchor shaft further includes proximal end
`portion 69, distal end portion 68, and locking means 70. In
`this embodiment, the anchor shaft may be referred to herein
`as a retraction anchor Shaft, because the physician holding
`the proximal end of the anchor Shaft retracts it proximally
`from its resting position in order to activate its curvature
`manipulation function. The anchor Shaft 62 can be retracted
`to tighten the radius of curvature of the distal portion 22 of
`the catheter body 18, thereby providing additional opera
`tional versatility. For example, Such an adjustment could
`convert a JR4 to a JR3 or Williams (3DRC) catheter. Anchor
`shaft 62 preferably is made of a softer material than the
`anchor shaft 14.
`A further embodiment is illustrated in FIG. 12. The
`guiding catheter device 110, includes a catheter body 117
`with a central lumen 118 extending between the proximal
`and distal ends, an extension anchor shaft 113 slidably
`positioned in a secondary lumen 112 formed by a sleeve 111
`positioned on the outer curvature of the catheter body 117,
`and a retraction anchor shaft 116 slidably positioned in a
`tertiary lumen 115 formed by a sleeve 114 positioned on the
`inner curvature of the catheter body 117. The retraction
`anchor shaft 116 is located at a position which is substan
`tially opposite the position of the extension anchor shaft 113
`on the circumference of the catheter body 117. The retrac
`tion anchor shaft 116 can be retracted to tighten the radius
`of curvature of the distal portion 119 of the catheter body
`117, thereby providing additional operational versatility. The
`extension anchor Shaft 113 can be advanced distally along
`the Secondary lumen 112, thereby causing the distal end
`portion 121 of the anchor shaft 113, as it exits from the
`secondary lumen 112, to bow or flex away from the catheter
`body 117 in the region between the hinge point 120 and the
`distal end of the sleeve 122. The loop that forms can be used
`to provide backup support for the distal tip 123 of the
`catheter and to facilitate greater control of the placement of
`the catheter tip. The retraction