BSC USP 8,142,413
`Exhibit 1036
`
`Page 1 of 49
`
`(12) United States Patent
`Carrillo, Jr. et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 6,997,908 B2
`*Feb. 14, 2006
`
`US006997908B2
`
`(54)
`
`(75)
`
`RAPID EXCHANGE CATHETER WITH
`DETACHABLE HOOD
`
`Inventors: Oscar R. Carrillo, J r., Attleboro, MA
`(US); James Yearick, ShreWsbury, MA
`(US); Robert C. Allman, Wake?eld,
`MA (US); Fernando Alvarez de
`Toledo, Concord, MA (US); Michael
`Ciannella, Marlborough, MA (US);
`Stephen C. Evans, Westford, MA (US)
`
`(73)
`
`Assignee:
`
`SciMed Life Systems, Inc., Maple
`Grove, MN (US)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 257 days.
`
`This patent is subject to a terminal dis
`claimer.
`
`(21)
`(22)
`(65)
`
`(63)
`
`(60)
`
`(51)
`
`Appl. No.: 10/327,379
`
`Filed:
`
`Dec. 20, 2002
`
`Prior Publication Data
`
`US 2003/0088153 A1
`
`May 8, 2003
`
`Related US. Application Data
`
`Continuation of application No. 09/519,649, ?led on
`Mar. 6, 2000, noW Pat. No. 6,520,951, Which is a
`continuation-in-part of application No. 09/312,340,
`?led on May 14, 1999, noW Pat. No. 6,346,093, Which
`is a continuation-in-part of application No. 09/080,
`520, ?led on May 18, 1998, noW Pat. No. 6,096,009,
`Which is a continuation-in-part of application No.
`08/926,200, ?led on Sep. 9, 1997, noW Pat. No.
`6,007,522.
`Provisional application No. 60/025,235, ?led on Sep.
`13, 1996.
`
`Int. Cl.
`A61M 5/178
`
`(2006.01)
`
`814
`
`84°
`
`(52) US. Cl. ........................... .. 604/167.06; 604/164.03
`(58) Field of Classi?cation Search ......... .. 604/165.01,
`604/165.02, 165.04, 164.13, 523, 533; 600/585;
`607/507, 508, 510, 514, 516
`See application ?le for complete search history.
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`1,204,053 A 11/1916 Moore
`(Continued)
`FOREIGN PATENT DOCUMENTS
`
`DE
`
`41 15 007 A1 11/1992
`(Continued)
`OTHER PUBLICATIONS
`
`Merriam-Webster Online, “3 entries found for about,” 2
`pages, Jul. 7, 2005*
`
`(Continued)
`Primary Examiner—Sharon Kennedy
`(74) Attorney, Agent, or Firm—Crompton, Seager & Tufte,
`LLC
`
`ABSTRACT
`(57)
`A single operator exchange biliary catheter having a com
`mon distal lumen. The biliary catheter includes an elongate
`shaft having a proximal portion de?ning an ancillary lumen
`and a distal portion de?ning a common guideWire and
`ancillary lumen. The common distal lumen reduces the
`pro?le of the distal portion of the shaft. The elongate shaft
`also includes a proximal guideWire port disposed betWeen
`the proximal end of the shaft and the distal end of the shaft
`to facilitate single operator use. A seal may be disposed
`adjacent the proximal guideWire port to thereby seal the port.
`Preferably, the shaft includes a single lumen distal portion
`and a bi-lumen proximal portion. The single lumen distal
`portion of the shaft may be curved and may include a tapered
`or spherically shaped distal tip.
`
`20 Claims, 34 Drawing Sheets
`
`808
`
`

`

`Page 2 of 49
`
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`0 328 760 A2
`0 388 112 A2
`0 792 657 A2
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`
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`
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`torne For Endoscopic Drainage of Pancreatic Pseudocyst”,
`gglsgrsoéngesséznal Endoscopy, vol. 37, No. 3, May/Jun. 1991,
`
`-
`
`-
`
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`2
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`2000, 7 Sheets_
`
`* cited by eXarniner
`
`

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`US. Patent
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`US. Patent
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`US. Patent
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`Feb. 14, 2006
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`US 6,997,908 B2
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`US. Patent
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`Feb. 14, 2006
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`US 6,997,908 B2
`
`1
`RAPID EXCHANGE CATHETER WITH
`DETACHABLE HOOD
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`This application is a continuation of application Ser. No.
`09/519,649, filed Mar. 6, 2000 now US. Pat. No. 6,520,951;
`which is a continuation-in-part of US. patent application
`Ser. No. 09/312,340, filed on May 14, 1999, entitled “Single
`Operator Exchange Biliary Catheter with Common Distal
`Lumen”, now US. Pat. No. 6,364,093; which is a continu-
`ation-in-part application of US. patent application Ser. No.
`09/080,520, filed on May 18, 1998, entitled “Guidewire and
`Catheter Locking Device and Method”, now US. Pat. No.
`6,096,009; which is a continuation-in-part application of
`US. patent application Ser. No. 08/926,200, filed on Sep. 9,
`1997, entitled “Single Operator Exchange Biliary Catheter”,
`now US. Pat. No. 6,007,522; which claims priority to US.
`Provisional Application No. 60/025,235, filed Sep. 13, 1996,
`entitled “Single Operator Exchange Biliary Catheter”, the
`entire disclosures of which are hereby incorporated by
`reference. This application is related to US. patent applica-
`tion Ser. No. 09/312,438, filed on May 14, 1999, entitled
`“Guidewire Insertion and Re-insertion Tools and Methods of
`
`Use”, the entire disclosure of which is hereby incorporated
`by reference.
`
`FIELD OF THE INVENTION
`
`invention generally relates to endoscopic
`The present
`devices and methods of use. Specifically, the present inven-
`tion relates to catheters for use in combination with
`
`guidewires and endoscopes.
`
`BACKGROUND OF THE INVENTION
`
`Endoscopic procedures for treating abnormal pathologies
`within the alimentary canal system and biliary tree (includ-
`ing the biliary, hepatic, and pancreatic ducts) are increasing
`in number. The endoscope provides access to the general
`area of a desired duct using direct visualization. However,
`the duct itself must be navigated using a catheter in con-
`junction with fiuoroscopy and guidewires.
`Catheters are known for treatment of targeted anatomical
`regions. Known methods and devices for using biliary
`catheters for accessing the biliary tree for performing cath-
`eter procedures are disclosed in Weaver et al., US. Pat. No.
`5,397,302 and Karpiel, US. Pat. No. 5,320,602, the disclo-
`sures of which are herein incorporated by reference. In
`general, for treatment of an abnormal pathology within a
`patient’s biliary tree, an endoscope is first introduced into
`the mouth of the patient. The endoscope includes a proximal
`end and a distal end, and has a lumen extending longitudi-
`nally between the proximal and distal ends. The endoscope
`is guided through the patient’s alimentary tract or canal until
`an opening at the distal end of the endoscope is proximate
`the area to receive treatment. At this point, the endoscope
`allows other components, such as a catheter, to access the
`targeted area.
`For visualization or treatment within the biliary tree, the
`distal end of the endoscope is positioned proximate the
`papilla of vater leading to the common bile duct and the
`pancreatic duct. A catheter is guided through the lumen of
`the endoscope until a distal tip of the catheter emerges from
`the opening at the distal end of the endoscope.
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`The catheter may be used for accessing the biliary tree.
`The distal end of the catheter is guided through the orifice to
`the papilla of vater (located between the sphincter of oddi)
`leading to the common bile duct and the pancreatic duct. A
`guidewire may be used in conjunction with the catheter to
`facilitate accessing a desired location within the biliary tree.
`The guidewire is inserted in an opening at a proximal end of
`the catheter and guided through the catheter until it emerges
`from the distal end of the catheter.
`
`If visualization of the common bile duct is desired, the
`guidewire is guided into the common bile duct. The catheter
`is advanced over the guidewire, as previously described,
`until
`the distal end of the catheter is positioned in the
`common bile duct at the desired location. The catheter is
`
`now in position for delivery of contrast media for fluoro-
`scopic visualization of anatomical detail within the common
`bile duct. Once the guidewire is in place relative to the
`targeted area, it is highly desirable to maintain that position
`of the guidewire during subsequent catheter procedures,
`including catheter exchange procedures.
`Present biliary endoscopic procedures include the use of
`multi-lumen catheters for endoscopic retrograde cholangio-
`pancreatography, endoscopic retrograde sphincterotomy, the
`use of balloon catheters having retrieval balloons, stenting,
`and other
`therapeutic and diagnostic procedures. As
`described in general above, these present biliary endoscopic
`procedures are performed using guidewire techniques. The
`present devices utilized in these procedures are at least 200
`cm long since they pass through the endoscope, which is
`commonly at least 150 cm long. Therefore, when using a
`standard catheter having a guidewire lumen extending the
`full length of the catheter, guidewires used during these
`procedures must be at least 450 cm in length to accommo-
`date the exchanging of different devices while maintaining
`access and position within the biliary tree. The exchange of
`devices over a 450 cm guidewire is both time consuming and
`cumbersome.
`
`Due to the length of the guidewire, physicians require at
`least
`two assistants in the room to perform the biliary
`endoscopic procedure. Typically, one assistant is responsible
`for the patient and device-related concerns, while the other
`assistant is responsible for the guidewire. The additional
`hands required due to the length of the guidewire results in
`a relatively more time consuming and costly procedure.
`It is desirable to have an exchange catheter suitable for
`use within the alimentary canal for accessing targeted ana-
`tomical regions, such as the biliary tree, having features
`which facilitate rapid exchange and allow an exchange
`procedure to be performed by a single operator. It is desir-
`able to have a biliary exchange catheter which may be used
`in connection with a shorter guidewire, and requires less
`personnel for performing biliary procedures. It is desirable
`to have a biliary exchange catheter which limits the amount
`of guidewire over which the catheter must travel.
`It
`is also desirable to have a biliary rapid exchange
`catheter which may be convertible for use between conven-
`tional guidewire techniques and rapid exchange guidewire
`techniques. It is desirable to have a biliary rapid exchange
`catheter which is easily removable from the guidewire, and
`adaptable for use with most catheter systems used within the
`alimentary canal. It would also be desirable to have an
`exchange catheter with a low profile distal portion available
`in a number of different sizes and shapes to accommodate
`variations in anatomy and provide access to treatment sites
`that would otherwise be difficult to reach.
`
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`US 6,997,908 B2
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`3
`SUMMARY OF THE INVENTION
`
`The present invention provides a single operator exchange
`biliary catheter having a common distal
`lumen thereby
`reducing the profile of the distal portion of the shaft. In an
`exemplary embodiment,
`the present invention provides a
`biliary catheter including an elongate shaft having a proxi-
`mal portion defining an ancillary lumen and a distal portion
`defining a common guidewire and ancillary lumen. The
`elongate shaft includes a proximal guidewire port disposed
`between the proximal end of the shaft and the distal
`guidewire port to facilitate single operator use.
`Aseal may be disposed adjacent proximate the guidewire
`port to thereby seal the port. Preferably, the seal provides a
`fluid seal with or without the guidewire disposed therein.
`The seal may be a wide variety of different types, including,
`but not limited to, a one-way valve type seal.
`Preferably, the shaft includes a single lumen distal portion
`and a bi-lumen proximal portion. The single lumen distal
`portion of the shaft may include a tapered or spherically
`shaped distal
`tip. The bi-lumen proximal portion may
`include a longitudinal channel providing access to the proxi-
`mal guidewire lumen.
`In preferred embodiments, a hood may be disposed
`between the proximal bi-lumen portion and the distal single
`lumen portion to assist
`the guidewire in entering the
`guidewire lumen. Also, a constraint tube may be disposed
`adjacent the proximal guidewire port to assist the guidewire
`into the proximal guidewire port.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a perspective view of a single operator exchange
`catheter in accordance with the present invention;
`FIG. 1A is a cross-sectional view of the catheter of FIG.
`
`1 taken along the line A—A;
`FIG. 1B is a cross-sectional view of the catheter with
`
`guidewire of FIG. 1 taken along the line B—B;
`FIG. 1C is an enlarged fragmentary perspective view of
`the catheter of FIG. 1 at circle C;
`FIGS. 1D and 1E are cross-sectional views of the frag-
`ment illustrated in FIG. 1C;
`FIGS. 2A—2D are cross-sectional views of the catheter of
`
`FIG. 1 located within increasingly larger endoscope chan-
`nels;
`FIG. 3 is a perspective view of an endoscope exchange
`sheath assembly, without a slit, suitable for receiving the
`catheter of FIG. 1;
`FIG. 3A is an enlarged fragmentary perspective view of
`the encircled sheath section of FIG. 3 at 3A;
`FIG. 4 is a perspective view of an alternative embodiment
`sheath assembly having a slit sheath and two-piece hub,
`shown in an unlocked position;
`FIG. 4A is a perspective view of the two-piece hub of
`FIG. 4 in a locked position;
`FIG. 4B is an enlarged fragmentary perspective view of
`the encircled sheath section of FIG. 4 at 4B, having a slit;
`FIG. 4C is an enlarged fragmentary perspective view of a
`sheath section, having an overlap, an alternate embodiment
`of the sheath in FIG. 4B;
`FIG. 5 is a perspective view of the catheter of FIG. 1
`inserted through the endoscope sheath assembly of FIG. 4;
`FIG. 6 is a perspective view of an endoscope sheath
`section containing a catheter having a U-shaped channel
`containing a guidewire;
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`FIG. 7 is a partial perspective view of a guidewire within
`the catheter of FIG. 1 inserted through the endoscope sheath
`assembly of FIG. 4, which is in turn within an endoscope;
`FIG. 7A is a perspective view of the sheath assembly of
`FIG. 7, having the catheter removed;
`FIG. 8 is a partial perspective view of an alternative
`embodiment of a sheath assembly, including an introducer;
`FIG. 8A is an enlarged perspective view of the introducer
`of FIG. 8;
`FIG. 9A is an enlarged, cross-sectional view of an alter-
`native embodiment of the introducer of FIG. 8;
`FIG. 9B is an enlarged, cross-sectional view of another
`alternative embodiment of the introducer of FIG. 8;
`FIG. 9C is an enlarged, cross-sectional view of another
`alternative embodiment of the introducer of FIG. 8;
`FIG. 9D is an enlarged, cross-sectional view of another
`alternative embodiment of the introducer of FIG. 8;
`FIG. 9E is an enlarged, perspective view of another
`alternative embodiment of the introducer of FIG. 8;
`FIG. 9F is an enlarged, cross-sectional view of another
`alternative embodiment of the introducer of FIG. 8;
`FIG. 10 is a perspective view of an illustrative locking
`device;
`FIG. 11 is a partial side view of an illustrative locking
`device positioned on an endoscope having an angled side
`port;
`FIG. 12 is a partial side view detailing the illustrative
`locking device of FIG. 11;
`FIG. 13 is a perspective view of another illustrative
`locking device;
`FIG. 14 is a perspective view of yet another illustrative
`locking device;
`FIG. 15 is a partial side view of another illustrative
`locking device positioned on an endoscope having an angled
`side port;
`FIG. 16 is a side view of a single operator exchange
`catheter in accordance with another embodiment of the
`
`present invention;
`FIG. 17 is a cross-sectional view taken along line 17—17
`in FIG. 16;
`FIG. 18 is a cross-sectional view taken along line 18—18
`in FIG. 16;
`FIG. 19A is a detailed side view of a first embodiment of
`section 19 in FIG. 16;
`FIGS. 20A—22A are cross-sectional views taken along
`lines 20A—20A, 21A—21A and 22A—22A, respectively,
`in FIG. 19A;
`FIG. 19B is a detailed side view of a second embodiment
`of section 19 in FIG. 16;
`FIGS. 20B—22B are cross-sectional views taken along
`lines 20B—20B, 21B—21B and 22B—22B, respectively, in
`FIG. 19B;
`FIG. 19C is a detailed side view of a third embodiment of
`section 19 in FIG. 16;
`FIGS. 20C—22C are cross-sectional views taken along
`lines 20C—20C, 21C—21C and 22C—22C, respectively, in
`FIG. 19C;
`FIGS. 23A—23C are detailed side views of several
`embodiments of section 23 in FIG. 16;
`FIGS. 24A—24C are cross-sectional views taken along
`lines 24A—24A, 24B—24B, and 24C—24C in FIGS.
`23A—23C, respectively;
`FIG. 25 is a plan view of a single operator exchange
`catheter in accordance with another embodiment of the
`
`present invention;
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`US 6,997,908 B2
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`5
`FIG. 26 is a detailed plan view of an entry region of one
`embodiment of the single operator exchange catheter of FIG.
`25;
`FIG. 27 is a partial perspective view of the catheter of
`FIG. 25 detailing a detachable hood;
`FIG. 28 is a detailed cross-sectional view of an entry
`region of one embodiment of the single operator exchange
`catheter of FIG. 25;
`FIG. 29 is a detailed cross-sectional view of an entry
`region of one embodiment of the single operator exchange
`catheter of FIG. 25 disposed within a lumen of a device;
`FIG. 30 is a detailed cross-sectional view of an entry
`region of one embodiment of the single operator exchange
`catheter of FIG. 25 disposed within a lumen of a device;
`FIG. 31 is a detailed plan view of an entry region of one
`embodiment of the single operator exchange catheter of FIG.
`25; and
`FIG. 32 is a detailed cross-sectional view of an entry
`region of one embodiment of the single operator exchange
`catheter of FIG. 25.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`The following detailed description should be read with
`reference to the drawings in which similar elements in
`different drawings are numbered the same. The drawings,
`which are not necessarily to scale, depict selected preferred
`embodiments and are not intended to limit the scope or spirit
`of the invention.
`
`FIG. 1 shows a perspective view of a catheter assembly 30
`in accordance with the present invention. Catheter assembly
`30 is used in catheter procedures for accessing targeted
`anatomical
`regions through the alimentary canal. The
`present invention incorporates features which allow rapid
`exchange of a catheter by a single operator. The catheter of
`the present invention allows shorter length guidewires to be
`used, resulting in procedures which require less medical
`personnel, are less time consuming, and less costly. Addi-
`tionally, the present invention is adaptable to most catheter
`devices used for catheter procedures within the alimentary
`canal.
`
`Catheter assembly 30 includes a catheter hub assembly 32
`and a catheter 34, having a guidewire 36 passing through a
`portion thereof. Catheter 34 includes a shaft 38, which in
`general terms has a proximal end 40, a U-channel 42, a distal
`tip region 44, a distal end 46 and various lumens described
`in greater detail below. Catheter hub assembly 32 is operably
`connected to proximal end 40 of shaft 38. Catheter hub
`assembly 32 is preferably configured to couple to ancillary
`devices allowing access to a lumen within shaft 38.
`Shaft 38 is a generally tubular shaped member having a
`generally uniform outer shape at proximal end 40. Shaft 38
`may be sized for slidable passage through the lumen of an
`endoscope (not shown). Shaft 38 is preferably formed in an
`extrusion process. Shaft 38 may be formed of an extruded
`polymeric material. In one embodiment, the preferred poly-
`meric material is polytetrafiuoroethylene, polyether block
`amide, nylon or a combination or blend of these. Catheters
`which are contemplated include, but are not
`limited to,
`cannulas, sphincterotomes, cytology devices, and devices
`for stone retrieval and stent placement.
`In a preferred embodiment, shaft 38 further includes a
`distal taper 48 which tapers to distal tip region 44. Addi-
`tionally, tip region 44 may include high contrast, color coded
`
`6
`distal markers 50. Finally, distal end 46 may be radiopaque
`for fluoroscopic visualization of distal tip region 44 during
`a catheter procedure.
`U-channel 42 of shaft 38 extends between a first, proximal
`channel end 52 and a second, distal channel end 54. U-chan-
`nel 42 serves to contain, but not necessarily constrain,
`guidewire 36, between channel proximal end 52 and channel
`distal end 54. The term “U-channel” refers to a channel
`
`shape that allows radial removal of guidewire 36 from the
`channel 42, and need not be strictly in the shape of the letter
`U. Channel 42 in the preferred embodiment is sufficiently
`large to allow unhindered radial guidewire 36 movement out
`of channel 42. Further, the channel walls and radial opening
`are substantially equal to or slightly larger than the diameter
`of a guidewire lumen, described in greater detail below.
`Although it is recognized that proximal channel end 52 may
`be located at any location distal of proximal end 40 of shaft
`38, channel distal end 54 is preferably located between 10
`and 40 cm from distal end 46 of catheter shaft 38.
`
`Finally, as shown in FIG. 1A, which is a cross-sectional
`view of shaft 38 taken along line A—A at a location
`proximal of channel proximal end 52, shaft 38 includes
`ancillary lumen 56, ancillary lumen 58 and guidewire lumen
`60.
`
`Ancillary lumen 56 and ancillary lumen 58 extend lon-
`gitudinally between proximal end 40 and distal end 46 of
`shaft 38. Ancillary lumen 56 and ancillary lumen 58 may be
`injection lumens, allowing for high contrast media flow
`capability for bubble-free opacification and for excellent
`visualization of a desired anatomical region. Additionally or
`alternatively, ancillary lumen 56 and/or ancillary lumen 58
`may be used for or as part of other ancillary devices, such
`as a cutting wire lumen or a retrieval balloon lumen.
`Guidewire lumen 60 extends longitudinally between
`proximal end 40 and distal end 46 of shaft 38 in the preferred
`embodiment. Further, guidewire lumen 60 is sized to receive
`guidewire 36. Guidewire lumen 60 may be a tubular member
`which is extruded integral catheter shaft 38, or alternatively,
`guidewire lumen 60 may be a separate tubular member
`which is coupled to catheter shaft 38. Although in one
`preferred embodiment the guidewire lumen 60 is a tubular
`member which is located proximate distal end 46 of catheter
`shaft 38, it is recognized that guidewire lumen 60 may be
`formed anywhere along shaft 38, may be an extension of
`shaft 38 coupled to distal end 46, or guidewire lumen 60 may
`run the entire length of shaft 38.
`Referring to FIG. 1B, a cross-sectional view of shaft 38
`taken along line B—B of FIG. 1 is shown. Guidewire 36
`may access guidewire lumen 60 at a point proximal channel
`distal end 54. Guidewire 36 extends within channel 42 to
`
`channel distal end 54, continuing within guidewire lumen 60
`through distal tip region 44, and exiting through an opening
`in distal end 46.
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`Referring to FIG. 1C, a section of catheter shaft 38 having
`U-channel 42 is shown. The embodiment shown also
`
`includes ancillary lumens 56 and 58. Sections of shaft 38
`proximate the channel proximal end 52 and distal channel
`distal end 54 contain guidewire lumen 60 in communication
`with U-channel 42. In one embodiment, U-channel 42 has an
`interior, closed-side geometry, substantially the same as the
`geometry of guidewire lumen 60. Further, U-channel 42
`walls are spaced further than a diameter of guidewire 36
`such that guidewire 36 moves freely into and out