US007273486B2
`
`(12) United States Patent
`Coyle et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7,273.486 B2
`Sep. 25, 2007
`
`(54) CATHETER WITH A CONVERTIBLE
`PROXMAL CATHETER SHAFT
`
`(75) Inventors: Noel Coyle, Galway (IE); Patrick
`Duane, Galway (IE)
`(73) Assignee: Medtronic Vascular, Inc., Santa Rosa,
`CA (US)
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 672 days.
`(21) Appl. No.: 10/411,087
`(22) Filed:
`Apr. 11, 2003
`
`(*) Notice:
`
`(65)
`
`Prior Publication Data
`US 2004/0204736A1
`Oct. 14, 2004
`
`(51) Int. Cl.
`(2006.01)
`A6M 29/00
`(52) U.S. Cl. .................................. 606/194; 604/103.04
`(58) Field of Classification Search .................. 604/43,
`604/103.04; 623/1.11: 606/194
`See application file for complete search history.
`References Cited
`
`(56)
`
`U.S. PATENT DOCUMENTS
`
`4,610,662 A * 9/1986 Weiklet al. ................ 604,509
`4,748,982 A
`6, 1988 Horzewski et al.
`4,762,129 A
`8, 1988 Bonzel
`4,988,356 A
`1/1991 Crittenden et al.
`5,040,548 A
`8, 1991 YOck
`5,061,273 A 10, 1991 YOck
`5,149,330 A
`9/1992 Brightbill
`5,171,222 A 12/1992 Euteneuer et al.
`5,178,158 A
`1/1993 de Toledo
`5, 195,978 A * 3/1993 Schiffer ...................... 604f161
`5,205,822 A
`4, 1993 Johnson et al.
`5,217,435 A
`6/1993 Kring
`5,232.445 A
`8, 1993 Bonzel
`5,263,932 A 11/1993 Jang
`5,279,539 A *
`1/1994 Bohan et al. ................. 600/37
`
`3, 1994 Kraus et al.
`5,290,241 A
`4, 1994 Yock
`5,300,085 A
`6/1994 Miraki
`5,324,269 A
`6/1994 Laboureau et al. ........... 606, 88
`5,324.296 A
`7, 1994 Griffith
`5,327,885 A
`8, 1994 Fischell et al.
`5,334,187 A
`5,336,184 A * 8/1994 Teirstein ................ 604/103.04
`5,350,395 A
`9, 1994 Yock
`5,357,978 A 10, 1994 Turk
`5,364,376 A 11/1994 Horzewski et al.
`5,387,226 A
`2, 1995 Miraki
`5,389,087 A
`2, 1995 Miraki
`5,409,459 A
`4/1995 Gambale
`5,451,233 A
`9, 1995 Yock
`5,458,639 A 10, 1995 Tsukashima et al.
`5,460,185 A 10, 1995 Johnson et al.
`5,466.222 A 1 1/1995 Ressemann et al.
`5,489,271 A
`2f1996 Andersen
`5,496.346 A
`3, 1996 Horzewski et al.
`5,501,227 A
`3, 1996 Yock
`5,531,700 A
`7/1996 Moore et al.
`5,549,556 A
`8/1996 Ndondo-Lay et al.
`
`(Continued)
`Primary Examiner Anhtuan T. Nguyen
`Assistant Examiner Elizabeth Houston
`
`(57)
`
`ABSTRACT
`
`A balloon catheter includes an inflation shaft and an elon
`gated guidewire shaft. A relatively short, distal portion of the
`guidewire shaft is attached to, or enveloped within, a distal
`portion of the inflation shaft. A proximal portion of the
`guidewire shaft is detached from and independent of a
`proximal portion of the inflation shaft. The detached portion
`of the guidewire shaft contains perforations at pre-deter
`mined points along its length that define removable seg
`ments thereof. The removable segments remain attached to
`the guidewire shaft under normal conditions, but may be
`torn away from the guidewire shaft to provide access to a
`guidewire within a guidewire lumen thereof.
`
`12 Claims, 5 Drawing Sheets
`
`
`
`116
`
`12- 204
`
`2OO Y
`
`Exhibit
`2224
`
`
`Page 1
`
`Teleflex Ex. 2224
`Medtronic v. Teleflex
`IPR2020-00135
`
`

`

`US 7,273.486 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`5,554,118 A * 9/1996 Jang ...................... 604.102.02
`5,571,094. A 11/1996 Sirhan
`5,578,009 A 11/1996 Kraus et al.
`5,626,600 A
`5, 1997 Horzewski et al.
`5,685,312 A 11/1997 Yock
`5,690,642 A * 11/1997 Osborne et al. ........... 623,111
`5,709,658 A
`1/1998 Sirhan et al.
`5,718,680 A
`2f1998 Kraus et al.
`5,749,888 A
`5, 1998 Yock
`5,755,685 A
`5, 1998 Andersen
`5,769,868 A
`6, 1998 Yock
`5,779,671 A
`7, 1998 Ressemann et al.
`5,807,355 A
`9/1998 Ramzipoor et al.
`5,919,164 A
`7, 1999 Andersen
`
`7, 1999 Sirhan
`5,919, 175 A
`9/1999 Ashiya et al.
`5,947,925 A
`9, 1999 Mertens
`5,947,927 A
`1/2000 Spiegelhalter
`6,013,068 A
`3, 2000 Yock
`6,036,715 A
`5/2000 Mickley
`6,056,719 A
`8, 2000 Windheuser et al.
`6,096,009 A
`9, 2000 Euteneuer et al.
`RE36,857 E
`6, 165,197 A 12/2000 Yock .......................... 606, 194
`6,196,995 B1
`3/2001 Fagan
`6,299,595 B1 10/2001 Dutta et al.
`6,569,180 B1* 5/2003 Sirhan et al. ............... 606, 194
`6,582.401 B1* 6/2003 Windheuser et al. .. 604/164.05
`6,682.556 B1* 1/2004 Ischinger ................... 623, 135
`
`* cited by examiner
`
`
`Page 2
`
`Teleflex Ex. 2224
`Medtronic v. Teleflex
`IPR2020-00135
`
`

`

`U.S. Patent
`
`Sep. 25, 2007
`
`Sheet 1 of 5
`
`US 7,273.486 B2
`
`O
`CN
`v
`
`CO
`O
`V
`
`CN
`O
`w
`
`OO
`O
`w
`
`s
`O
`V
`
`&
`
`S
`
`S.
`
`S
`
`-r
`3
`
`
`Page 3
`
`Teleflex Ex. 2224
`Medtronic v. Teleflex
`IPR2020-00135
`
`

`

`U.S. Patent
`
`Sep. 25, 2007
`
`Sheet 2 of 5
`
`US 7,273.486 B2
`
`
`
`s
`
`
`Page 4
`
`Teleflex Ex. 2224
`Medtronic v. Teleflex
`IPR2020-00135
`
`

`

`U.S. Patent
`
`Sep. 25, 2007
`
`Sheet 3 of 5
`
`US 7,273.486 B2
`
`
`
`91.9
`
`80G
`
`
`Page 5
`
`Teleflex Ex. 2224
`Medtronic v. Teleflex
`IPR2020-00135
`
`

`

`U.S. Patent
`
`Sep. 25, 2007
`
`Sheet 4 of 5
`
`US 7,273.486 B2
`
`
`
`
`Page 6
`
`Teleflex Ex. 2224
`Medtronic v. Teleflex
`IPR2020-00135
`
`

`

`U.S. Patent
`
`Sep. 25, 2007
`
`Sheet S of 5
`
`US 7,273.486 B2
`
`
`Page 7
`
`Teleflex Ex. 2224
`Medtronic v. Teleflex
`IPR2020-00135
`
`

`

`US 7,273,486 B2
`
`1.
`CATHETER WITH A CONVERTIBLE
`PROXMAL CATHETER SHAFT
`
`BACKGROUND OF THE INVENTION
`
`2
`onto the in-place guidewire and tracked to the lesion.
`However, one problem associated with RX catheters is that
`the external portion of the guidewire may become tangled
`with the catheter shaft during use.
`In addition, there are instances when the guidewire and
`not the catheter must be replaced. For example, the
`guidewire may become damaged during the procedure or it
`may be discovered during the procedure that a different
`shape, length, or size of guidewire is needed. An OTW
`catheter, with the guidewire lumen extending the entire
`length of the catheter, allows for simple guidewire exchange.
`With a RX catheter, the guidewire lumen does not extend the
`entire length of the catheter. Therefore, current RX catheter
`designs do not allow for simple guidewire exchange while
`the catheter remains in place. The guidewire, and most of the
`catheter, must be removed from the body in order to
`exchange guidewires. Essentially the procedure must then
`start anew because both the guidewire and the catheter must
`be retracked to the treatment site.
`A balloon catheter capable of both simple guidewire
`exchange and catheter exchange without the use of an
`exchange guidewire is particularly advantageous. A catheter
`designed to eliminate the need for guidewire extensions or
`exchange guidewires is disclosed in U.S. Pat. No. 4.988,356
`to Crittenden et al., incorporated in its entirety herein by
`reference. This MX catheter includes a catheter shaft having
`a cut that extends longitudinally between the proximal end
`and the distal end of the catheter and that extends radially
`from the catheter shaft outer surface to the guidewire lumen.
`A guide member through which the shaft is slidably move
`able functions to open the cut Such that the guidewire may
`extend transversely into or out of the guidewire lumen at any
`location along its length. By moving the shaft with respect
`to the guide member, the effective over-the-wire length of
`the MX catheter is adjustable.
`When using the MX catheter, the guidewire is maneu
`vered through the patient's vascular system such that the
`distal end of the guidewire is positioned across the treatment
`site. With the guide member positioned near the distal end
`of the catheter, the proximal end of the guidewire is threaded
`into the guidewire lumen opening at the distal end of the
`catheter and through the guide member Such that the proxi
`mal end of the guidewire protrudes out the proximal end of
`the guide member. By Securing the guide member and the
`proximal end of the guidewire in a fixed position, the
`catheter may then be transported over the guidewire by
`advancing the catheter toward the guide member. In doing
`So, as the catheter advances toward the guide member, the
`guidewire lumen envelops the guidewire and the catheter is
`advanced into the patients vasculature. In a PTCA embodi
`ment, the MX catheter may be advanced over the guidewire
`in this manner until the distal end of the catheter having the
`dilatation balloon is positioned within the stenosis and
`essentially the entire length of the guidewire is encompassed
`within the guidewire lumen.
`Furthermore, the indwelling MX catheter maybe
`exchanged with another catheter by reversing the operation
`described above. To this end, the indwelling catheter may be
`removed by withdrawing the proximal end of the catheter
`from the patient while holding the proximal end of the
`guidewire and the guide member in a fixed position. When
`the catheter has been withdrawn to the point where the distal
`end of the cut has reached the guide member, the distal
`portion of the catheter over the guidewire is of a sufficiently
`short length that the catheter may be drawn over the proxi
`mal end of the guidewire without releasing control of the
`guidewire or disturbing its position within the patient. After
`
`1. Field of the Invention
`The present invention relates to a medical device. More
`specifically, the invention relates to a balloon catheter that
`has an elongated, detached guidewire shaft that may be torn
`away during catheter exchange.
`2. Background of the Invention
`Cardiovascular disease, including atherosclerosis, is the
`leading cause of death in the U.S. One method for treating
`atherosclerosis and other forms of coronary narrowing is
`percutaneous transluminal coronary angioplasty, commonly
`referred to as “angioplasty” or “PTCA’. The objective in
`angioplasty is to enlarge the lumen of the affected coronary
`artery by radial hydraulic expansion. The procedure is
`accomplished by inflating a balloon of a balloon catheter
`within the narrowed lumen of the coronary artery. Radial
`expansion of the coronary artery occurs in several different
`dimensions, and is related to the nature of the plaque. Soft,
`fatty plaque deposits are flattened by the balloon, while
`hardened deposits are cracked and split to enlarge the lumen.
`One or multiple dilations may be necessary to effectively
`dilate the artery. In many instances, successive dilations
`using a Succession of balloon catheters with balloons of
`increasingly larger diameters may be required. In order to
`accomplish the multiple dilations, the original catheter must
`be removed and a second balloon catheter tracked to the
`lesion. When catheter exchange is desired, it is advanta
`geous to leave the guidewire in place while the first catheter
`is removed in order to insert the second catheter without
`having to reestablish the path by inserting a new guidewire.
`To remove a balloon catheter while leaving the guidewire in
`place, there must be a portion of the guidewire extending out
`of the balloon catheter at the proximal end so that the
`guidewire can be held in place while the balloon catheter is
`removed.
`Two types of catheters commonly used in angioplasty
`procedures are referred to as over-the-wire (OTW) catheters
`and rapid exchange (RX) catheters. A third type of catheter,
`referred to as a multi-exchange (MX) catheter, is discussed
`below. An OTW catheter's guidewire shaft runs the entire
`length of the catheter and is attached to, or enveloped within,
`an inflation shaft. Thus, the entire length of an OTW catheter
`is tracked over a guidewire during a PTCA procedure. A RX
`catheter, on the other hand, has a guidewire shaft that
`extends within only the distalmost portion of the catheter.
`Thus during a PTCA procedure only the distalmost portion
`of a rapid exchange catheter is tracked over a guidewire.
`If a catheter exchange is required while using a standard
`OTW catheter, the user must add an extension onto the
`proximal end of the guidewire to maintain control of the
`guidewire, slide the catheter off of the extended guidewire,
`slide the new catheter onto the guidewire and track back into
`position. Multiple operators are required to hold the
`extended guidewire in place while the original catheter is
`changed out.
`A RX catheter avoids the need for multiple operators
`when changing out the catheter and therefore is often
`referred to as a “single operator” catheter. With a rapid
`exchange catheter, the guidewire is outside the shaft of the
`catheter for all but the distalmost portion of the catheter. The
`guidewire can be held in place without an extension when
`the catheter is removed from the body. Once the original
`catheter is removed, a Subsequent catheter may be threaded
`
`10
`
`15
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`
`Page 8
`
`Teleflex Ex. 2224
`Medtronic v. Teleflex
`IPR2020-00135
`
`

`

`US 7,273,486 B2
`
`3
`the catheter has been removed, another catheter may be
`threaded onto the guidewire and advanced over the
`guidewire in the same manner described above with regard
`to the MX catheter. The MX catheter not only permits
`catheter exchange without the use of the very long exchange
`guidewire and without requiring withdrawal of the initially
`placed guidewire, but it also overcomes many of the other
`difficulties discussed in association with RX catheters.
`It is among the general objects of the invention to provide
`an alternative catheter which allows for simple guidewire
`exchange and fluid delivery. Therefore, what is needed is a
`catheter design that overcomes the disadvantages set forth
`above. Specifically, what is needed is a catheter which
`allows for catheter and/or guidewire exchange without the
`use of an exchange guidewire, and which avoids the disad
`vantages associated with prior art catheter designs. Accord
`ingly, there arises a need for an OTW catheter having a
`detached guidewire shaft which allows for catheter and/or
`guidewire exchange without the use of an exchange
`guidewire.
`
`BRIEF SUMMARY OF THE INVENTION
`
`To achieve the foregoing and other objects, and in accor
`dance with the purposes of the present invention as embod
`ied and broadly described herein, the balloon catheter of the
`present invention provides a balloon catheter capable of
`catheter exchange without the use of an exchange guidewire
`while also allowing for simple guidewire exchange. The
`balloon catheter essentially is comprised of an inflation shaft
`with an inflation lumen, a guidewire shaft with a guidewire
`lumen, and a balloon.
`The present invention can form the basis of a stent
`delivery system, as well as an angioplasty catheter. In the
`present invention, the balloon catheter has an elongated
`guidewire shaft that acts as a conduit for a guidewire and
`stretches up to the full length of the balloon catheter. The
`guidewire shaft’s distal portion of a relatively short length is
`attached to, or enveloped within, the inflation lumen but the
`remainder of the full length guidewire shaft is detached from
`the inflation lumen. The detached portion of the guidewire
`shaft also contains perforations at pre-determined points
`along its length that define removable segments of the
`guidewire shaft. The removable segments remain attached to
`the guidewire shaft under normal conditions, but may be
`torn away from the guidewire shaft to provide access to a
`guidewire within the guidewire lumen as necessary during a
`procedure.
`Further, a balloon is mounted at the distal portion of the
`inflation shaft. The balloon can be of any shape or size
`customarily used in angioplasty procedures. The inflation
`shaft includes an inflation port to allow fluid communication
`between the inflation lumen and the balloon so that the
`balloon may be inflated.
`The present invention is used in a similar manner to an
`OTW catheter initially. An extended (two-part) guidewire
`(approx. 300 centimetres) is tracked to the treatment site.
`Once in place the balloon catheter of the present invention
`is slid onto the guidewire and tracked to the treatment site.
`When a sufficient portion of the extended guidewire pro
`trudes out of the proximal end of the guidewire lumen, the
`proximal part of the guidewire may be removed, thus
`shortening the guidewire to the normal, single-user length
`(approx. 180 centimeters). Alternatively, the balloon cath
`eter may be slid onto a single-user length guidewire outside
`of the body after which both the guidewire and catheter are
`tracked into position.
`
`4
`In situ, the guidewire extends the entire length of the
`catheter within a guidewire shaft. A portion of the guidewire
`shaft proximal of the balloon is freely detached from the
`catheters inflation shaft. Thus, unlike standard RX cath
`eters, the elongated detached proximal guidewire shaft
`reduces the chance of tangling of the guidewire with the
`inflation shaft and allows for simple guidewire exchange. To
`change the guidewire, the user can pull the current guidewire
`proximally out of the guidewire shaft and feed a new
`guidewire into the proximal end of the guidewire shaft while
`the balloon catheter remains in position over the treatment
`site, as per standard OTW procedure but not currently
`possible with a RX catheter.
`However, unlike standard OTW catheters, the present
`invention also allows for catheter exchange without the use
`of an exchange guidewire. With the present invention the
`user may slide the catheter proximally until the portion of
`the guidewire which extends externally of the patient is
`almost entirely within the guidewire lumen. The user then
`tears-off the most proximal removable segment of the
`guidewire shaft which exposes more of the guidewire. The
`catheter is then slid proximally until again the portion of the
`guidewire which extends externally of the patient is almost
`entirely covered by the guidewire shaft at which point the
`user can tear-off the next removable segment of guidewire
`shaft. This procedure is repeated until the tip of the catheter
`exits the body and control of the guidewire may be gained
`distal to the catheter tip and the catheter is fully removed
`from the guidewire. A new catheter may then be slid over the
`guidewire.
`
`BRIEF DESCRIPTION OF THE
`DRAWINGSFFIGURES
`
`The foregoing and other features and advantages of the
`invention will be apparent from the following, more par
`ticular description of a preferred embodiment of the inven
`tion, as illustrated in the accompanying drawings.
`FIG. 1 is a side elevational view of a stent delivery system
`incorporating the present invention.
`FIG. 2 is an enlarged view of a transition portion 200 of
`the catheter of FIG. 1.
`FIG. 3 is a sectional view along line A-A of FIG. 2 in
`accordance with an embodiment of the present invention.
`FIG. 4 is a sectional view along line A-A of FIG. 2 in
`accordance with another embodiment of the present inven
`tion.
`FIG. 5 is a sectional view along line A-A of FIG. 2 in
`accordance with another embodiment of the present inven
`tion.
`FIG. 6 is a cross-sectional view of a catheter in accor
`dance with an embodiment of the present invention taken
`along line B-B of FIG. 2.
`FIG. 7 is a cross-sectional view of a catheter in accor
`dance with another embodiment of the present invention
`taken along line B-B of FIG. 2.
`FIG. 8 is a side elevational view of a balloon delivery
`system incorporating the present invention.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`A preferred embodiment of the present invention is now
`described with reference to the figures, where like reference
`numbers indicate identical or functionally similar elements.
`Also in the figures, the left most digit of each reference
`number corresponds to the figure in which the reference
`
`10
`
`15
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`
`Page 9
`
`Teleflex Ex. 2224
`Medtronic v. Teleflex
`IPR2020-00135
`
`

`

`5
`number is first used. While specific configurations and
`arrangements are discussed, it should be understood that this
`is done for illustrative purposes only. A person skilled in the
`relevant art will recognize that other configurations and
`arrangements can be used without departing from the spirit
`and scope of the invention.
`Referring to FIG. 1, an embodiment of a stent delivery
`system utilizing a catheter according to the present invention
`is shown. A balloon catheter 100 is provided with an
`inflation shaft 102, a guidewire shaft 110, and a balloon 118.
`Inflation shaft 102 has a proximal portion 104, a distal
`portion 106, and an inflation lumen 108 therein. Guidewire
`shaft 110 has an elongated proximal portion 112, a relatively
`short distal portion 114, and a guidewire lumen 116 therein.
`Balloon 118 may be heat welded or glued onto distal portion
`106 of inflation shaft 102, and the interior of balloon 118 is
`in fluid communication with inflation lumen 108. Proximal
`portion 104 of inflation shaft 102 is in fluid communication
`with a hub 122 that allows inflation means (not shown) to be
`connected thereto for inflation of balloon 118. In addition,
`stent 120 is located on balloon 118. Catheter 100 is shown
`as a stent delivery system in FIG. 1, but may be used in
`balloon angioplasty and/or drug delivery procedures. FIG. 8
`shows a balloon catheter 800, an embodiment of the present
`invention utilizing balloon catheter 800 in a balloon angio
`plasty procedure.
`Inflation shaft 102 is made of any appropriate polymeric
`material. Possible materials used in construction of inflation
`shaft 102 are polyethylene terephalate (PET), which allows
`for very thin walls while withstanding high inflation pres
`Sures; nylon, which provides a Soft material; and polyeth
`ylene, which is advantageous for its compatibility with new
`angioplasty techniques, such as lasers. The proximal portion
`of inflation shaft 102 is formed from a reinforced polymeric
`tube or a metal hypo tube. Guidewire shaft 110 may be made
`of any appropriate polymeric material. Non-exhaustive
`examples of material for guidewire shaft 110 include poly
`ethylene, PEBAX, nylon or combinations of any of these,
`either blended or co-extruded. Preferred materials for infla
`tion shaft 102 and the guidewire shaft 110 are polyethylene,
`nylon, PEBAX, or co-extrusions of any of these materials.
`Balloon 118 can be any appropriate shape or size, and any
`material, which is relatively elastic and deformable. Non
`exhaustive examples for balloon 118 include polymers such
`as polyethylene, PEBAX, PET, nylon, polyurethane.
`Guidewire shaft 110 acts as a conduit for a guidewire and
`stretches up to the full length of balloon catheter 100. Distal
`portion 114 of guidewire shaft 110 is attached to, or envel
`oped within, inflation lumen 108. The remainder of full
`length guidewire shaft 110, i. e., proximal portion 112, is
`detached from inflation shaft 102. The elongated guidewire
`shaft 110 allows for simple guidewire exchange. To change
`a guidewire, the user can pull the current guidewire proxi
`mally out of guidewire shaft 110 and feed a new guidewire
`into the proximal end of guidewire shaft 110 while balloon
`catheter 100 remains in position within a body lumen, as per
`standard over-the-wire procedure but not currently possible
`with a typical rapid exchange catheter. In addition, elongated
`guidewire shaft 110 prevents the problem of inflation shaft
`102 becoming entangled with a guidewire, which may occur
`during use of typical rapid exchange catheters.
`FIG. 2 is an enlarged view of a transition portion 200 of
`FIG. 1, and shows the location at which guidewire shaft 110
`becomes detached from and independent of inflation shaft
`102. As shown in FIG. 2, proximal portion 112 of guidewire
`shaft 110, which is detached from inflation shaft 102, also
`includes perforations 202 at pre-determined points along its
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`US 7,273,486 B2
`
`10
`
`15
`
`6
`length. Perforations 202 define removable segments 204
`along proximal portion 112 of guidewire shaft 110. In one
`embodiment of the present invention, the perforations may
`be circumferentially placed about guidewire shaft 110. In
`another embodiment of the invention, the perforations may
`extend from an outer Surface to an inner Surface of proximal
`portion 112 of guidewire shaft 110 so as to form “slots'
`therein. Removable segments 204 remain attached as proxi
`mal portion 112 of guidewire shaft 110 under normal con
`ditions, but may be torn away, singly or in multiples, from
`guidewire shaft 110 to provide access to a guidewire dis
`posed therein.
`Removable segments 204 allow for catheter exchange
`without the use of an exchange guidewire. With the present
`invention the user may slide balloon catheter 100 proximally
`until the portion of the guidewire extending outside the
`patient’s body is almost entirely covered by proximal por
`tion 112 of guidewire shaft 110. The user then “tears-off the
`most proximal removable segment 204 of guidewire shaft
`110 thereby exposing more of the guidewire. Balloon cath
`eter 100 is then slid proximally until again the guidewire is
`almost entirely covered by proximal portion 112 of
`guidewire shaft 110 at which point the user can tear-off the
`next removable segment 204 of guidewire shaft 110. This
`procedure is repeated until a distal tip 124 of catheter 100
`exits the body and control of the guidewire may be gained
`at the point of its entry into the body. Balloon catheter 100
`is then slid proximally to be fully removed from the
`guidewire. A new catheter may then be slid over the
`guidewire that has remained in position during removal of
`balloon catheter 100.
`FIG. 3 is a sectional view at the location along line A-A
`of FIG. 2, and illustrates an embodiment of transition
`portion 200 of catheter 100. Transition portion 200 is located
`proximal of distal tip 124. Transition portion 200 is prefer
`ably located, but is not limited to, a distance of between 15
`and 28 centimetres proximal of distal tip 124. FIG. 3
`illustrates an inner surface 302 and an outer surface 304 of
`inflation shaft 102, and an inner surface 306 and an outer
`surface 308 of guidewire shaft 110. In this embodiment of
`the present invention, distal portion 114 of guidewire shaft
`110 is disposed coaxially within inflation shaft 102, with a
`space between outer surface 308 of guidewire shaft 110 and
`inner surface 302 of inflation shaft 102 serving as inflation
`lumen 108 and being in fluid communication with balloon
`118. Inflation ports (not shown) are located on inflation shaft
`102 to provide fluid communication between an interior of
`balloon 118 and inflation lumen 108. This embodiment of
`balloon catheter 100 features guidewire lumen 116 and
`inflation lumen 108 in a coaxial arrangement. Other embodi
`ments of balloon catheter 100 may have guidewire lumen
`116 and inflation lumen 108 in other dual lumen arrange
`ments, such as a circular guidewire lumen above a D-shaped
`inflation lumen or a circular guidewire lumen set above a
`crescent-shaped inflation lumen.
`Within transition portion 200, at the point where proximal
`portion 112 of guidewire shaft 110 becomes detached from
`inflation shaft 102, guidewire shaft 110 generally protrudes
`externally from outer surface 304 of inflation shaft 102. At
`this point a bond is formed between the guidewire and
`inflation shafts to join the shafts and to ensure a Smooth
`transition between the detached proximal portions of the
`shafts and the joined distal portions of the shafts. Generally,
`a Support mandrel, or wire, is placed within guidewire shaft
`110 to traverse the bonding area to ensure that guidewire
`lumen 116 remains open post bond formation. With the
`Support mandrel remaining within guidewire lumen 116.
`
`
`Page 10
`
`Teleflex Ex. 2224
`Medtronic v. Teleflex
`IPR2020-00135
`
`

`

`7
`perforations 202 may be formed using either a single,
`moveable blade, a collet-type arrangement of numerous
`blades or by directional laser. After perforations 202 are
`formed, the Support mandrel may be removed.
`FIG. 4 is an alternate embodiment along line A-A of FIG.
`2, and illustrates another embodiment of transition portion
`200 of catheter 100. Alternatively, a guidewire shaft 410
`maybe disposed within an inflation shaft 402 in a non
`coaxial relationship. This alternate configuration results in a
`guidewire lumen 416 and an inflation lumen 408 being in a
`side-by-side arrangement in the distal portion of the catheter.
`FIG. 5 is an alternate embodiment along line A-A of FIG.
`2, and illustrates another embodiment of transition portion
`200 of catheter 100. Alternatively, a guidewire shaft 510
`maybe attached to an outside surface 504 of an inflation
`shaft 502. This alternate configuration has a guidewire
`lumen 516 and an inflation lumen 508 disposed in a side
`by-side relationship in the distal portion of the catheter.
`FIG. 6 is a cross-sectional view of a portion of balloon
`catheter 100 taken along line B-B of FIG. 2, and illustrates
`a coaxial dual lumen arrangement as discussed with refer
`ence to FIG. 3. As apparent in FIG. 6, inflation lumen 108
`is formed between outer surface 308 of guidewire shaft 110
`and inner surface 302 of inflation shaft 102 to allow inflation
`media to flow into balloon 118. FIG. 6 shows a guidewire
`602 within guidewire lumen 116.
`FIG. 7 is an alternate embodiment of balloon catheter 100
`taken along line B-B of FIG. 2, and illustrates a non-coaxial
`arrangement of guidewire lumen 416 and inflation lumen
`408 as discussed with reference to FIG. 4. Guidewire 602 is
`shown within guidewire shaft 410.
`While this invention has been particularly shown and
`described with reference to preferred embodiments thereof,
`it will be understood by those skilled in the art that various
`changes in form and details may be made therein without
`departing from the spirit and scope of the invention.
`What is claimed is:
`1. A balloon catheter comprising:
`an inflation shaft having a proximal portion, a distal
`portion, and an inflation lumen;
`a guidewire shaft having a proximal portion with perfo
`rations that are circumferential around around the
`guidewire shaft to define removable segments that are
`detachable from a remainder of the guidewire shaft at
`the perforations, a distal portion, an outer Surface, an
`inner Surface, and a guidewire lumen, wherein the
`proximal portion of the guidewire shaft is detached
`from and independent of the proximal portion of the
`inflation shaft; and
`a balloon disposed on the distal portion of the inflation
`shaft, wherein an interior of the balloon is in fluid
`communication with the inflation lumen.
`2. The balloon catheter of claim 1, wherein the inflation
`shaft includes an inflation port to provide fluid communi
`cation between the interior of the balloon and the inflation
`lumen.
`
`10
`
`15
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`US 7,273,486 B2
`
`8
`3. The balloon catheter of claim 1, wherein the distal
`portion of the guidewire shaft is attached to the distal portion
`of the inflation shaft.
`4. The balloon catheter of claim 3, wherein the distal
`portion of the guidewire shaft is disposed within the inflation
`lumen of the distal portion of the inflation shaft.
`5. The balloon catheter of claim 1, wherein the guidewire
`shaft extends substantially the length of the balloon catheter.
`6. The balloon catheter of claim 1, wherein the perfora
`tions extend from the outer surface to the inner surface of the
`guidewire shaft.
`7. The balloon catheter of claim 1, wherein the removable
`segments are tubular.
`8. The balloon catheter of claim 7, wherein the tubular
`removable segments are cylindrically shaped.
`9. A stent delivery system comprising:
`a balloon catheter, the balloon catheter including,
`an inflation shaft having a proximal portion, a distal
`portion, and an inflation lumen;
`a guidewire shaft having a proximal portion with perfo
`rations defining removable tubular segments thereof, a
`distal portion, and a guidewire lumen, wherein the
`proximal portion of the guidewire shaft is detached
`from the inflation shaft and the removable segments are
`detachable from the remainder of the guidewire shaft at
`the perforations to thereby reduce a length of the
`guidewire lumen; and
`a balloon disposed on the inflation shaft, wherein an
`interior of the balloon is in fluid communication with
`the inflation lumen; and
`a stent mounted on the balloon.
`10. A catheter comprising:
`a flexible first tube having a proximal portion, a distal
`portion, an outer Surface, and an inner Surface;
`a flexible second tube having a proximal portion with
`perforations defining removable tubular segments
`thereof, a distal portion, an outer Surface, and an inner
`Surface, wherein the proximal portion of the second
`tube is detached from the first tube and the removable
`tubular segmen