`(12) Patent Application Publication (10) Pub. No.: US 2003/0195546A1
`(43) Pub. Date:
`Oct. 16, 2003
`Solar et al.
`
`US 2003O195546A1
`
`(54) ENHANCED CATHETER WITH ALIGNMENT
`MEANS
`(76) Inventors: Ronald J. Solar, San Diego, CA (US);
`Glen L. Lieber, Poway, CA (US)
`Correspondence Address:
`REED SMITH, LLP
`ATTN: PATENT RECORDS DEPARTMENT
`599 LEXINGTON AVENUE, 29TH FLOOR
`NEW YORK, NY 10022-7650 (US)
`(21) Appl. No.:
`10/428,668
`(22) Filed:
`May 2, 2003
`Related U.S. Application Data
`(63) Continuation of application No. 09/629,768, filed on
`Jul. 31, 2000, which is a continuation-in-part of
`application No. 09/454.255, filed on Dec. 2, 1999,
`now Pat. No. 6,447,501, which is a continuation-in
`
`part of application No. 09/312,529, filed on May 14,
`1999, now Pat. No. 6,394,995.
`(60) Provisional application No. 60/085,636, filed on May
`15, 1998.
`
`Publication Classification
`
`(51) Int. Cl. ................................................ A61M 29/00
`(52) U.S. Cl. ..................... 606/192; 604/103.04; 604/528
`(57)
`ABSTRACT
`A balloon dilatation System is comprised of an elongated
`flexible advancement member which terminates in a tubular
`tracking member Slidable over a guidewire. An inflatable
`balloon has proximal and distal ends, the proximal end
`communicating with an inflation channel, and the distal end
`attaching to the tracking member. The balloon portion is
`coextensive with but not attached to the advancement mem
`ber. An alignment member aligns the advancement member
`and the inflation channel. Other embodiments relate to
`delivery of Stents or other medical instrumentalities.
`
`
`
`Page 1
`
`Medtronic Exhibit 1463
`
`
`
`Patent Application Publication Oct. 16, 2003 Sheet 1 of 8
`
`US 2003/0195546 A1
`
`
`
`Page 2
`
`Medtronic Exhibit 1463
`
`
`
`Patent Application Publication Oct. 16, 2003 Sheet 2 of 8
`
`US 2003/0195546 A1
`
`
`
`N
`
`O
`
`Page 3
`
`Medtronic Exhibit 1463
`
`
`
`Patent Application Publication Oct. 16, 2003 Sheet 3 of 8
`
`US 2003/0195546A1
`
`
`
`Page 4
`
`Medtronic Exhibit 1463
`
`
`
`Patent Application Publication Oct. 16, 2003 Sheet 4 of 8
`
`US 2003/0195546 A1
`
`
`
`s
`
`Page 5
`
`Medtronic Exhibit 1463
`
`
`
`Patent Application Publication Oct. 16, 2003 Sheet 5 of 8
`
`US 2003/0195546 A1
`
`
`
`&
`
`8
`
`NO
`Q
`
`Page 6
`
`Medtronic Exhibit 1463
`
`
`
`Patent Application Publication Oct. 16, 2003 Sheet 6 of 8
`
`US 2003/0195546 A1
`
`
`
`(N
`S.
`
`Page 7
`
`Medtronic Exhibit 1463
`
`
`
`Patent Application Publication
`
`Oct. 16, 2003 Sheet 7 of 8
`
`US 2003/0195546A1
`
`
`
`Page 8
`
`Medtronic Exhibit 1463
`
`
`
`Patent Application Publication
`
`Oct. 16, 2003 Sheet 8 of 8
`
`US 2003/0195546A1
`
`
`
`Page 9
`
`Medtronic Exhibit 1463
`
`
`
`US 2003/O195546 A1
`
`Oct. 16, 2003
`
`ENHANCED CATHETER WITH ALIGNMENT
`MEANS
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`0001. This application is a continuation of co-pending
`U.S. patent application Ser. No. 09/629,768, filed Jul. 31,
`2000, which in turn is a continuation-in-part of U.S. patent
`application Ser. No. 09/454.255, filed, Dec. 2, 1999, now
`U.S. Pat. No. 6,447,501, which is a continuation-in-part of
`U.S. patent application Serial No. 09/312,529, filed May 14,
`1999, now U.S. Pat. No. 6,394,995, which is based upon
`U.S. Provisional Patent Application Serial No. 60/085,636,
`filed May 15, 1998.
`
`SCOPE OF THE INVENTION
`0002 This invention relates to the fields of angioplasty
`and other interventional procedures. More particularly, this
`invention relates to improved balloon dilatation Systems
`where the distal end of the inflatable dilatation balloon is
`attached to a tubular tracking member or an advancement
`member and alignment means align the tracking member
`and an inflation channel.
`
`BACKGROUND OF THE INVENTION
`Balloon dilatation catheters have been used to
`0.003
`dilate various types of Strictures in blood vessels and other
`body lumens for Over twenty years. Typically, Such catheters
`comprise a balloon mounted on the distal end of an elon
`gated flexible Shaft and an inflation tube or lumen extending
`longitudinally within the shaft from its proximal end to the
`interior of the balloon. Among the major advancements in
`balloon dilatation catheters have been the development of
`Smaller catheters that can be used in Smaller and/or more
`distal anatomical locations, and the development of cath
`eters that can be rapidly exchanged. Examples of Such
`catheters are described in U.S. Pat. No. 4,748,982 (Horize
`wski), Pat. No. 4,762,129 (Bonzel), Pat. No. 5,040,548
`(Yock), Pat. No. 5,061.273 (Yock), Pat. No. 5,569,199
`(Solar) and Pat. No. 5,728,067 (Enger). Because these
`catheters have become more Sophisticated and complex in
`design, and despite the manufacturers's experience in manu
`facturing them, these catheters are expensive to make.
`Furthermore, despite these improvements, difficulties are
`Still encountered in advancing catheters through tortuous
`anatomy and safely crossing very tight Strictures and
`Stenoses in the vascular System and other body lumens or
`cavities.
`0004 Recently vascular stents have been shown to play
`an important role in reducing the restenosis rates associated
`with balloon angioplasty. However, Stents are Sometimes
`lost from the delivery systems and are difficult to retrieve
`Safely. In addition, Stents cannot completely overcome the
`trauma and injury that result from balloon dilatation. Thus,
`there is a need for enhanced balloon dilatation catheters.
`
`OBJECTS OF THE INVENTION
`0005. It is an object of the invention to provide an
`enhanced dilatation System that is extremely low-profile to
`more easily and Safely croSS very tight Strictures and
`Stenoses in the vascular System and other body lumens or
`cavities.
`
`0006. It is also an object of the invention to provide an
`enhanced dilatation System that provides for an improved
`means for crossing tight Stenoses, as well as to navigate
`tortuous anatomy.
`0007. It is another object of the invention to provide an
`enhanced dilatation system that has the ability to be
`eXchanged rapidly.
`0008. It is yet another object of the invention to provide
`an enhanced dilatation System that can be used to retrieve
`dislodged Stents.
`0009. It is a further object of the invention to provide an
`enhanced dilatation System that can be manufactured inex
`pensively and more reliably then currently available balloon
`dilatation Systems.
`0010. It is also an object of the invention to provide an
`enhanced dilatation System that allows placement of an
`additional catheter or instrumentality adjacent to a catheter.
`0011. It is likewise an object of the invention to provide
`an enhanced dilatation System that facilitates placement of
`Stents or Stent grafts.
`0012. It is a yet further object of the invention to provide
`a balloon catheter System and a stent delivery System having
`a Smaller profile for crossing tight Stenoses.
`0013 These and other objects of the invention will
`become more apparent from the discussion below.
`
`SUMMARY OF THE INVENTION
`0014. According to the invention, an enhanced balloon
`dilatation delivery System comprises an elongated advance
`ment member which optionally terminates in a tubular
`tracking member, an inflatable dilatation balloon having
`proximal and distal ends and being in fluid communication
`with an inflation channel, and means for aligning the
`advancement member and the inflation channel. The proxi
`mal end of the inflatable balloon is in fluid communication
`with the inflation channel, and the distal end of the inflatable
`balloon is attached to the tubular tracking member or the
`advancement member. During advancement of the System,
`the inflatable dilatation balloon and inflation channel are
`Somewhat coextensive with the advancement member. The
`System is slidable over a guidewire.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0015 The above and other objects and advantages of the
`invention will be apparent upon consideration of the fol
`lowing detailed description, taken in conjunction with the
`accompanying drawings, in which the reference characters
`refer to like parts throughout and in which:
`0016 FIGS. 1 to 3 are each a schematic, lateral view of
`an embodiment of the invention;
`0017 FIG. 4 is an enlarged illustration of the distal
`portion of an additional embodiment of the invention;
`0018 FIG. 5 is an enlarged illustration of the proximal
`portion of an alternate embodiment of the invention;
`0019 FIG. 6 is a cross-sectional view of a clamping
`member used in the FIG. 5 embodiment;
`
`Page 10
`
`Medtronic Exhibit 1463
`
`
`
`US 2003/O195546 A1
`
`Oct. 16, 2003
`
`0020 FIGS. 7 and 8 are each a schematic, lateral view
`of an additional embodiment of the invention;
`0021
`FIG. 9 is a schematic, partly cross-sectional view
`of another embodiment of the invention and FIG. 10 is a
`cross-sectional view across line 10-10;
`0022 FIG. 11 is an alternate cross-sectional view of
`FIG. 10;
`0023 FIGS. 12, 13 and 14 are each a schematic repre
`Sentation of another embodiment of the invention; and
`0024 FIG. 15 is a detail of FIG. 14.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`0025. With reference to FIGS. 1 to 3, an enhanced
`catheter System, designated generally as 1, has an elongated
`advancement member 5. Preferably advancement member 5
`is formed of a flexible wire or, alternately, of spring hollow
`hypotubing. Advancement member 5 preferably has a diam
`eter of from about 0.008" to 0.035", which diameter could be
`larger or Smaller depending on the application. Advance
`ment member 5 has sufficient column strength and flexibility
`to provide for advancement of the catheter through tortuous
`anatomy. Preferably, advancement member 5 is rigid at its
`proximal end and becomes increasingly more flexible as it
`extends distally. This may be accomplished by a number of
`ways known in the art, including, but not limited to, taper
`ing, Selective heat treatment and/or forming advancement
`member 5 from a composite of materials with various
`properties.
`0.026 Advancement member 5 terminates at its distal end
`6 in an elongated tubular tracking member 7. Tracking
`member 7 has a tubular configuration and is adapted to slide
`over a Standard guidewire 9 to allow System 1 to advance
`easily to a desired location within a patient's body. Tracking
`member 7 has an open proximal end 11 and an open distal
`end 8, and is preferably formed of a flexible polymeric tube,
`a Spring coil, or a combination thereof. Tracking member 7
`is preferably about 10 to 50 cm long and has an inner
`diameter that is sized to accommodate guidewire 9, most
`preferably approximately from about 0.012" to 0.040".
`Optionally tracking member 7 has an inner, Outer, or inner
`and outer coating with a lubricious material to aid in its
`movement over the guidewire. Lubricious materials for this
`purpose are well-known in the art.
`0.027 Advancement member 5 and tracking member 7
`are attached by any Suitable means known in the art, Such as
`by fusion or a non-toxic adhesive. Alternatively, advance
`ment member 5 and tracking member 7 may be integrally
`formed during manufacture.
`0028 System 1 also has an inflatable balloon 10 having
`a proximal end 12 and distal end 14. Distal end 14 of balloon
`10 is attached to tracking member 7 by any suitable means
`known in the art, Such as by fusion, adhesive bonding or
`integral formation, and moves therewith. Distal end 14 of
`balloon 10 may be attached to distal end 8 of tracking
`member 7, as shown in FIG. 1, or preferably, distal end 14
`of balloon 10 is attached to the proximal end 11 of tracking
`member 7, as shown in FIG. 3. Balloon 10 is formed of a
`very thin-walled, preferably less than 0.001" thick, poly
`meric material. Balloon 10 may be formed of any one of a
`
`variety of suitable materials known in the art. Optionally
`balloon 10 may be suitable for dilatation and/or deployment
`of a Stent.
`0029 Proximal end 12 of balloon 10 communicates with
`an elongated inflation channel 15 that extends proximally
`through a corporeal lumen. Inflation means 15 is formed
`preferably of a polymeric tubular film that will allow infla
`tion channel 15 to collapse to a smaller profile when not
`being used for inflation of balloon 10. The wall thickness of
`inflation channel 15 should preferably be less than 0.001".
`When inflated, inflation channel 15 will have a diameter of
`approximately 0.010" or more, depending upon the appli
`cation. Alternatively, inflation channel 15 may be fabricated
`out of a non-collapsible tubing material as would be familiar
`to one skilled in this art. As shown in FIG. 3, inflation
`channel 15 may have position markers 13 on its proximal
`portion. Position markers 13, which may be applied by ink
`or other Suitable means known in the art, correspond to
`Similar markers on advancement member 5. Such markers
`provide visual confirmation of concurrent movement of
`inflation channel 15 and advancement member 5 during
`advancement and withdrawal of System 1.
`0030) Inflation channel 15 has a hub 16 at its opposite,
`proximal end. Hub 16 is a standard LUER(R) lock connector
`that allows connection of inflation means 15 to standard
`balloon inflator devices or syringes (not shown). By this
`means, balloon 10 is in fluid communication with an inflator.
`0031. As noted above, distal end 14 of inflatable balloon
`10 is attached to tubular tracking member 7. In this way, as
`tubular tracking member 7 travels through the body along
`the path of guidewire 9, inflatable balloon 10 is pulled along
`with tracking member 7 to the desired site. However,
`although balloon 10 lies coextensively with advancement
`member 5 (FIGS. 2 and 3) and/or tracking member 7 (FIG.
`1), it is unattached to advancement member 5. In this most
`preferred embodiment of least attachment, pushing on
`advancement member 5 causes balloon 10 to be easily
`pulled through the anatomy and tight Strictures and Stenoses.
`Since the balloon is not being pushed through a Stenosis,
`there is no tendency for the balloon to compress longitudi
`nally and increase in profile and bulk. Such an occurrence,
`which may be found in prior art catheters where the balloon
`is attached proximally and distally to the catheter shaft, can
`impede advancement and crossing, as well as result in
`vascular trauma and clinical complications. Since there is no
`bulky catheter structure within the interior of the balloon (as
`is found in prior art catheters), the verythin balloon material
`can easily fold and conform as required to croSS a Stenosis
`with minimal friction and trauma as it is pulled acroSS by the
`tracking member.
`0032. As shown in FIG.3 a wire 2 can optionally extend
`at least partially within the inflation channel 15 to the distal
`end 14 of balloon 10. Wire 2 may provide support to the
`inflation channel 15 and balloon 10 which may be required
`in Some applications. The Support wire may be permanently
`mounted, or alternatively, it may be removable and used as
`needed. Also, as shown in FIG. 3, the dilatation system may
`have radiopaque markers 17 to allow the System's position
`to be monitored, and the proximal ends of the advancement
`member 5 and/or inflation channel 15 may have one or more
`visual markers 13 to indicate the lengths inserted. The
`radiopaque markers may be comprised of conventional
`
`Page 11
`
`Medtronic Exhibit 1463
`
`
`
`US 2003/O195546 A1
`
`Oct. 16, 2003
`
`radiopaque materials. Such as gold or platinum, and the
`Visual markers may be comprised of physiological accept
`able inks or coatings, preferably in bright or fluorescent
`colors.
`0033. The embodiment of the invention shown in FIG. 7
`has an inflatable balloon 22 and a flexible, torqueable,
`advancement member 23. The distal portion 24 of balloon
`22 is fixedly attached to the distal end 25 of advancement
`member 23. Advancement member distal end 25 may
`optionally have a flexible Spring tip 26.
`0034) The proximal portion 27 of balloon 22 is in fluid
`communication with an inflation channel or means 28 hav
`ing a hub 29 for connection to an inflation Source (not
`shown). Inflation channel 28 preferably is attached to or
`wound about advancement member 23 in Spiral fashion, in
`such a way to lower the profile of the system but to not
`interfere with the fluid communication.
`0.035 A torquer or rotator member 30 may optionally grip
`the proximal portion of advancement member 23 and infla
`tion channel 28, to allow radial positioning of advancement
`member 23. In this embodiment it is preferred that the
`inflation means Spirally wrap around the advancement mem
`ber. Turning the proximal end of the advancement member
`with torquer 30 will allow distal end 25 of the advancement
`member 23 to be positioned at a desired radial location
`relative to balloon 22 within a corporeal lumen. A torquer 30
`could also be used with the embodiments shown in FIGS. 1
`and 2, where the tracking means and advancement means
`would be radially positioned.
`0036). In FIG. 9, an enhanced balloon dilatation system,
`designated generally as 80, has an elongated advancement
`member 82. Preferably advancement member 82 is formed
`of a flexible wire or, alternately, of Spring hollow hypotub
`ing, and has the characteristics described above.
`0037 Advancement member 82 terminates at its distal
`end 84 in a tubular tracking member 86. Tracking member
`86 has a tubular configuration and is adapted to Slide over a
`standard guidewire 88 to allow system 80 to advance easily
`to a desired location within a patient's body. Tracking
`member 86 has an open proximal end 90 and an open distal
`end 92, and is preferably formed of a flexible polymeric
`tube, a Spring coil, or a combination thereof. Tracking
`member 86 is preferably about 3 to 30 cm long and has an
`inner diameter that is sized to accommodate guidewire 88,
`most preferably approximately from about 0.012" to 0.040".
`Optionally tracking member 86 has an inner, outer, or inner
`and outer coating with a lubricious material to aid in its
`movement over the guidewire.
`0.038 Advancement member 82 and tracking member 86
`are attached by any Suitable means known in the art, Such as
`by fusion or a non-toxic adhesive, or, alternatively, have
`been integrally formed during manufacture.
`0039 System 80 also has an inflatable balloon 94 having
`a proximal end 96 and distal end 98. Distal end 98 of balloon
`94 is attached to advancement member 82 or tracking
`member 86 by any suitable means known in the art, such as
`by fusion, adhesive bonding or integral formation, and
`moves therewith. Distal end 98 of balloon 94 may be
`attached to advancement member 82, as shown in FIG. 9, or
`optionally distal end 98 of balloon 94 can be attached to the
`proximal end 90 of tracking member 86, as similar to the
`
`arrangement shown in FIG. 3. Balloon 94 is formed of a
`very thin-walled, preferably less than 0.001" thick, poly
`meric material, of any one of a variety of Suitable materials
`known in the art.
`0040 Proximal end 96 of balloon 94 communicates with
`an elongated inflation channel 100 that extends proximally
`through a corporeal lumen. Inflation channel 100 is formed
`preferably of a polymeric tubular film that will allow infla
`tion channel 100 to collapse to a smaller profile when not
`being used for inflation of balloon 94. When inflated,
`inflation channel 100 will have a diameter of approximately
`0.010" or more, depending on the application. Alternatively,
`inflation channel 100 may be fabricated out of a non
`collapsible tubing material as would be familiar to one
`skilled in this art.
`0041) Inflation channel 100 has a hub 101 at its opposite,
`proximal end. Hub 101 is a standard LUER(R) lock connector
`that allows connection of inflation channel 100 to standard
`balloon inflator devices or syringes (not shown). By this
`means, balloon 94 is in fluid communication with an inflator.
`0042 An alignment member or sheath 102 extends lon
`gitudinally, whereby it encompasses at least inflation chan
`nel 100. Alignment member 102 preferably is attached to or
`integral with advancement member 82, and preferably
`advancement member 82 also is encompassed by alignment
`member 102. Alignment member 102 can be comprised of
`any suitable flexible or substantially flexible medically
`acceptable material, Such as a polymer or metal. In a
`preferred embodiment alignment sheath comprises a stain
`less steel hypotube and advancement member 82 is bonded
`to its inner or outer Surface.
`0043. The distal end 104 of alignment member 102 is
`open, and the proximal end 106 of alignment member 102
`is optionally attached to hub 101, optionally with an opening
`for the proximal portion 108 of advancement member 82.
`0044) In the cross-sectional view along line 10-10 in
`FIG. 9 that is represented by FIG. 10, advancement member
`82 and inflation channel 100 are positioned within alignment
`member 102. However, in an alternative embodiment
`reflected in FIG. 11, advancement member 82 is attached to
`the outer surface 110 of alignment member 102.
`0045. In a preferred embodiment the advancement mem
`ber has a proximal portion and a distal portion. The proximal
`portion has at least one lumen having open ends. Inflation
`channel 100 is positioned within one of said lumens and the
`proximal portion of the advancement member functions as
`the alignment member. The distal portion of the advance
`ment member extends distally from the distal end of the
`proximal portion of the advancement member.
`0046. In a preferred embodiment of the invention a stent
`or Stent graft may be delivered. An example of this preferred
`embodiment is shown in FIG. 12. In this embodiment, an
`inflatable balloon 40 is folded and formed into a tubular
`shape, and a Stent or Stent graft 42 is mounted onto the
`balloon by various methods known in the art Such as, for
`example, crimping, interference fit, or encapsulation. See,
`for example, U.S. Pat. Nos. 4,800,882 and 5,836,965. In this
`embodiment, the distal end 44 of balloon 40 is attached to
`advancement means 46 adjacent to the distal end of
`advancement means 46, and the balloon/stent assembly
`
`Page 12
`
`Medtronic Exhibit 1463
`
`
`
`US 2003/O195546 A1
`
`Oct. 16, 2003
`
`40/42 acts as a tracking member. The proximal end 48 of
`balloon 40 is in fluid communication with hub 50 through
`flexible conduit 52.
`0047 Alternatively, the embodiment illustrated in FIG. 1
`may be used to deliver a stent or stent graft. With the distal
`end 14 of balloon 10 attached to the distal end 8 of the
`tracking member 7, the balloon is folded around tracking
`member 7, and the stent/stent graft 54 is mounted onto the
`folded balloon (FIGS. 1 and 13). Tracking member 7 is
`advanced over guidewire 9.
`0048. In the embodiment shown in FIGS. 14 and 15, the
`distal end 62 of an inflatable balloon 64 is attached to the
`proximal end 66 of a tracking member 68. Balloon 64 is
`folded and formed into a tubular shape, and a Stent or Stent
`graft 70 is mounted onto the balloon by various methods
`known in the art. Optionally, a sheath can be extended over
`the Stent (various designs and methods are known in the art).
`0049. To summarize use of the embodiments of the
`present invention described above, a guidewire is first laid in
`place within a corporeal lumen through any of the means
`well-known in the art. With use of an advancement member,
`a tracking member or folded balloon is advanced into the
`corporeal lumen over the guidewire. AS the advancement
`member or folded balloon is advanced into the corporeal
`lumen, an inflatable balloon is pulled along with it by virtue
`of the attachment of its distal end to the tracking member or
`the advancement member. Once the inflatable balloon is in
`a desired position within the corporeal lumen, the balloon is
`inflated via the inflation means and hub.
`0050. It is contemplated that the tracking member can be
`varied to provide alternative embodiments of the catheter
`System of the invention. For example, the length of the
`tracking member may either be made longer or shorter. In
`the embodiment of the invention shown in FIG. 2, the
`tracking means has been shortened to a loop 18. Alterna
`tively, it is contemplated that the tracking member may
`extend as an elongated tubular member the full length of
`System, from a proximal position outside the body lumen all
`the way to its distal end, to allow fluid administration of the
`treatment Site. Also, the distal end of the advancement
`member could extend distally of the tracking member.
`Moreover, in one embodiment of the invention the inflatable
`balloon may be detachable.
`0051. In addition, it is contemplated that the tracking
`member may be Single-lumen, So that it accommodates only
`a guidewire, or it may be multi-lumen, So that it can perform
`other functions as well. For example, the multi-lumen track
`ing member 19 shown in FIG. 4 contains lumen 3 for
`advancing over guidewire 9 and lumen 20, which provides
`a convenient means for attachment to advancement member
`5. Advancement member 5 may be hollow to provide an
`alternative means for fluid administration to the treatment
`Site. Lumen 20 may be open at the distal end 4 of tracking
`member 19, and tracking member 19 may alternatively have
`side holes 21 which provide communication from lumen 20
`to the exterior of tracking member 19. Tracking member 19
`may also be enlarged and/or lengthened to facilitate perfu
`Sion during balloon inflation.
`0.052
`It is further contemplated that, in some applica
`tions, it may be deemed desirable to provide one or more
`additional attachment points between the inflation channel
`
`and the advancement member at various locations along the
`advancement member's length. A preferred method of
`attachment employs a removable clamping member 22 as
`shown in FIGS. 5 and 6. Clamping member 22 holds
`inflation channel 15 Stationary with respect to advancement
`member 5 during withdrawal of catheter system 1. Clamping
`member 22 is preferably removed or loosened during cath
`eter System advancement to optimize the pulling forces on
`the balloon. It is contemplated that in Some instances more
`than one clamp 22 might be used.
`0053. Further, it is envisioned that the inflatable balloon
`and the inflation channel may be formed from the same
`material or they may be formed independently and Subse
`quently attached by Suitable known means. In addition, the
`distal extension of the balloon may be molded or otherwise
`formed to the shape of the tracking member.
`0054.
`In yet another alternative preferred embodiment of
`the invention, the advancement member and the tracking
`member may be formed in multiple Segments each having
`varying mechanical properties which will allow for the
`customization of the catheter to a particular need.
`0055. The catheter systems of the present invention pro
`vides the user with a number of Significant advantages not
`otherwise obtainable with currently available catheters. For
`example, they are leSS bulky than other available catheter
`Systems and thus the balloon is able to move against
`resistance more easily, which allows leSS traumatic crossing
`of restrictions. Also, pushing on the advancement member
`has the effect of pulling the balloon along through the
`Stenosis, and avoids the problem of bunching or gathering
`which occurs with other catheters. With a thin film balloon
`and inflation channel there is no dead Space or Volume that
`needs to be evacuated prior to use; therefore, little or no
`preparation is required. The Smaller profile of the catheter
`system of the invention allows the inflatable balloon to be
`passed through stents easily. Partial inflation of the inflatable
`balloon can grab a previously inserted Stent and facilitate
`retrieval of the stent. The smaller profile also permits
`passage through displaced Stent Struts.
`0056 Separating the inflatable balloon from a catheter
`shaft allows greater design flexibility to allow one to provide
`catheter Systems with improved handling characteristics,
`and the fewer bonds between the balloon and the advance
`ment shaft results in greater reliability. The simplicity of
`construction of the System of the present invention results in
`lower manufacturing costs. For example, fewer bonding
`operations are required, and expensive balloon folding pro
`ceSSes can be avoided. Inflating the balloon against the
`advancement member or tracking member provides a
`focused force to enable the user to crack hard lesions at low
`pressure before the balloon is fully inflated. Doing so would
`allow vessel Stretching to occur at a lower Strain rate, which
`would minimize the trauma associated with balloon dilata
`tion. With a guidewire in place, the balloon can be inflated
`additionally against the guidewire, thus providing an addi
`tional area of focused force.
`0057. A further advantage of the present invention is that
`the design allows additional catheters or devices to be placed
`over the guidewire adjacent to the inflatable balloon, and to
`be exchanged without first removing the catheter System. In
`addition, the advancement member may also act as an
`additional guidewire. For example, while balloon catheter 1
`
`Page 13
`
`Medtronic Exhibit 1463
`
`
`
`US 2003/O195546 A1
`
`Oct. 16, 2003
`
`is in place within a vascular lesion, a Second dilatation
`System or catheter may be advanced over the advancement
`member and its balloon positioned along Side the first
`balloon (to increase the effective diameter of the dilatation)
`or adjacent to the first balloon (to increase the effective
`length of the dilatation). An imaging catheter Such as an
`intravascular ultrasound catheter may be placed next to the
`first balloon to access the progreSS of the treatment without
`removing the balloon. A drug delivery catheter may be
`utilized in this manner, and the balloon of System 1 may be
`inflated at low pressure to provide vascular occlusion to
`improve the efficacy of the drug delivery. Likewise, various
`other catheters and devices may be Suitably employed.
`0.058 Although the discussion above has been concerned
`with inflatable balloon Systems and/or catheters, other types
`of catheters or Systems may embody the present invention as
`schematically illustrated in FIG. 8. In FIG. 8, advancement
`member 5 terminates in a tubular tracking member 7, which
`tracks over guidewire 9. Distal end 32 of instrumentality 31
`is attached to tracking member 7. Proximal end 33 of
`instrumentality 31 is unattached to either advancement
`member 5 or tracking member 7. Instrumentality 31 may be
`a laser, infusion tube, Suction device, atherectomy means,
`other Stent expansion means or another therapeutic or diag
`nostic apparatus. AS required, a connecting member 34 may
`be attached to instrumentality 31. Connecting member 34
`may be an electrical conducting wire, optical fiber, tube, or
`the like.
`0059. It will thus be seen that the objects set forth above,
`among those made apparent from the preceding description,
`are efficiently attained, and Since certain changes may be
`made in the constructions Set forth without departing from
`the Spirit and Scope of the invention, it is intended that all
`matter contained in the above description and shown in the
`accompanying drawings shall be interpreted as illustrative
`and not in a limiting Sense.
`0060. It is also to be understood that the following claims
`are intended to cover all of the generic and Specific features
`of the invention herein described and all statements of the
`Scope of the invention, which, as a matter of language, might
`be said to fall therebetween.
`
`What is claimed is:
`1. A balloon dilatation catheter System comprising:
`a flexible elongated advancement member having a distal
`end,
`a tracking member having a proximal end and a distal end,
`Said tracking member being adapted to slide over a
`guidewire and being fixedly attached to the distal end
`of the advancement member,
`an inflation channel, and
`an inflatable dilatation balloon having proximal end and
`distal end, the proximal end of the balloon being in
`fluid communication with the inflation channel,
`wherein the distal end of the balloon is attached to the
`tracking member and an alignment member aligns the
`advancement member and the inflation channel in the
`longitudinal direction.
`2. The catheter System of claim 1, wherein the tracking
`member comprises two or more lumens.
`
`3. The catheter system of claim 1, wherein the dilatation
`balloon is attached to the distal end of the tracking member.
`4. The catheter system of claim 1, wherein the dilatation
`balloon is attached to the proximal end of the tracking
`member.
`5. The catheter system of claim 1, wherein the tracking
`member has