BSC USP 8,048,032
`Exhibit 1041
`
`Page 1 of 6
`
`.
`
`United States Patent [19]
`Buchbinder et al.
`
`[54] EXCHANGE CATHETER HAVING
`EXTERIOR GUIDE WIRE Loops
`
`[75] Inventors: Maurice Buchbinder, San Diego;
`Glen Lieber, Poway; Ronald J. Solar,
`San Diego; Leo R. Roucher, Jr., .
`Escondido, an of Calm
`[73] Assignee: Medtronic, Inc., Minneapolis, Minn.
`21 A l N 8597 9
`[
`1
`_pp' 0"
`’ 6
`[22] Filed:
`Mar‘ 30’ 1992
`[51] Int. Cl.5 ......................................... .. A61M 29/00
`[52] US. Cl. .................................... .. 604/96; 604/280;
`606/ 194
`[58] Field of Search .............................. .. 128/656-658,
`128/772; 606/192, 194; 604/49, 52, 96,
`101402, 280
`‘
`
`.
`'
`References cued
`U.S. PATENT DOCUMENTS
`
`[56]
`
`:33??? """"""""""""""""""""""
`128/344
`4,748,982 6/1988 Horzewski .
`.... .. 128/344
`4.762,l29 8/1988 Bonzel
`4,771,782 9/1988 Millar ................................ .. 128/637
`
`llllllllllllllIlllllllllllllllllllllllllllIllllllllllllllllllllllllllllllll
`
`US005267958A
`
`[11] Patent Number:
`[45] Date of Patent:
`
`5,267,958
`Dec. 7, 1993
`
`4,824,435 4/ 1989 Giesy ................ ................ .. 604/49
`4,850,358 7/1989 Millar ............ ..
`128/637
`4,988,356 1/1991 Crittenden .... ..
`606/192
`5,040,548 8/1991 Yock ..... ..
`'
`128/898
`5,046,497 9/1991 Millar .... ..
`128/637
`5,057,120 10/1991 Farcot ................... .. 606/194
`5,061,273 10/1991 Yock ..................... ..
`606/194
`5,180,367 l/l993 Kontos et al. .................... .. 604/101
`
`FOREIGN PATENT DOCUMENTS
`0380227 1/1990 European Pat. on. .
`' Primary Examiner-C. Fred Rosenbaum
`Assistant Examiner--Oorrine Maglione
`Attorney, Agent, or Firm-Dianne M. F. Plunkett;
`Harold R. Patton
`
`ABSTRACT
`[57]
`A balloon catheter is disclosed having a catheter body
`and one or more loops external to the body and spaced
`from the balloon for insertion of a guidewire. A peel
`able sheath with a guidewiare lumen can instead be
`mounted exterior to the catheter body for holding the
`guidewire. The catheter body may optionally be rein
`fmced ‘"1111 a style‘
`~
`
`12 Claims, 1 Drawing Sheet
`
`

`

`US. Patent
`
`Dec. 7, 1993
`
`5,267,958
`
`
`
`Page 2 of 6
`
`US. Patent
`
`Dec. 7, 1993
`
`5,267,958
`
`

`

`Page 3 of 6
`
`1
`
`EXCHANGE CATHETER HAVING EXTERIOR
`GUIDE WIRE LOOPS
`
`5,267,958
`2
`is desirable. Current ?xed wire catheters, sometimes
`known as balloons on wires, are unable to maintain
`position within a select vessel as easily as over-the-wire
`catheters. A catheter is needed which allows a wire to
`be left behind following therapy. The wire is then ad
`vanced with the catheter across the diseased area. The
`wire is deployed distal to the diseased area and the
`catheter is removed.
`
`FIELD OF THE INVENTION
`This invention relates to catheters which are ex
`changeable over a guidewire.
`BACKGROUND OF THE INVENTION
`In some catheterization therapies, a ?rst catheter is
`preferably removed from the body after therapy and
`replaced with a second catheter.
`One example of this exchange is in the use of balloon
`catheters in the treatment of stenosis in ‘arteries. A cur
`rent technique is the expansion of a partially occluded
`lumen in an artery through the use of a ?rst balloon of
`a low pro?le. Once a lesion is opened, a larger balloon
`may be used to complete the opening of the occluded
`area.
`The exchange of catheters can be a complex task.
`Prior art catheters commonly were inserted over a
`guidewire which extended in a lumen through the cath
`eter. It was dif?cult to feed such a catheter onto a
`guidewire while a guidewire was in the body because of
`friction encountered when feeding the catheter through
`the artery. Additionally, the guidewire must be held
`while a catheter is loaded over it. Previously a physi
`cian loaded the catheter over a guidewire extension
`outside of the body and then slid it over the portion of
`the guidewire inside the body. This required a long
`30
`guidewire extension outside the body as the guidewire
`extension had to be longer than the catheter. This long
`guidewire extension was dif?cult to keep out of the way
`during the surgical process. It also required an addi
`tional individual to handle the guidewire during the
`exchange process.
`Various techniques have been tried to overcome this.
`For example, the catheter disclosed in US. Pat. No.
`4,762,129 to Bonzel has a short lumen through the inte
`rior of a balloon. In Bonzel, the balloon lumen rides on
`40
`the guidewire and the guidewire is outside the rest of
`the catheter body. In this way, only a portion of the
`guidewire which is as long as the balloon need extend
`outside the body for loading. The catheter itself must be
`stiff enough to be independently pushed through the
`artery.
`Rapid exchange catheter art includes internal dual
`lumen apparatus and related devices such as US. Pat.
`Nos. 5,061,273 and 5,040,548 to Yock. Other rapid ex
`change techniques include slitted exchange sleeves such
`as that shown in US. Pat. No. 4,748,982 to Horzewski
`or U.S. Pat. No. 4,824,435 to Giesy as well as guiding
`tip rings such as US. Pat. No. 4,824,435 to Giesy. The
`narrow loop width of such guiding tip rings offer little
`support and reduce the pushability and tracking of their
`attached devices.
`This description of art is not intended to constitute an
`admission that any patent, publication or other informa
`tion referred to is “prior art” with respect to this inven
`tion, unless speci?cally designated as such. In addition,
`this section should not be construed to mean that a
`search has been made or that no other pertinent infor
`mation as de?ned in 37 CPR. § l.56(a) exists.
`What is needed is a catheter design with a low pro?le
`through the balloon area, preferably with support for a
`guidewire in more locations along the catheter, to aid in
`pushability as well as aiding the tracking of the attached
`device. Additionally, a catheter with a smaller shaft size
`
`45
`
`SUMMARY OF THE INVENTION
`I The present invention relates to a catheter which has
`means, mounted external to a catheter body and spaced
`apart from the therapy means or balloon, for insertion
`of a guidewire. The external means is preferably one or
`5
`_’more loops mounted on one side of the catheter body.
`The external loops can all be mounted proximally to the
`balloon or one external loop can be mounted distally to
`the balloon and the balance of the external loops
`mounted proximally to the balloon.
`In another embodiment, the invention includes a peel
`able sheath mounted on the exterior of a catheter body
`including a lumen for holding the guidewire. The exter
`nal loops may also be peelable.
`In another embodiment, the catheter body is rein
`forced with a stylet.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a side plan view of a catheter embodying the
`present invention.
`FIG. 2 is a cross-sectional view taken on line 2-2 of
`FIG. 1.
`FIG. 3 is a cross-sectional view taken on line 3—3 of
`FIG. 1.
`FIG. 4 is an enlarged partially broken away view of
`the guidewire lumen of the catheter of FIG. 1, with a
`loop in cross-section.
`FIG. 5 is a side plan view partially broken away of an
`alternative embodiment of the present invention.
`FIG. 6 is an enlarged cross-sectional view taken on
`line 6-6 of FIG. 5.
`FIG. 7 is a side elevational view of an alternative
`embodiment of the present invention.
`FIG. 8 is a side elevational view of an alternative
`embodiment of the present invention.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`A first embodiment of the present invention, as illus
`trated in
`FIG. 1, is a catheter 10 which includes a body 12, a
`therapy means such as balloon 14, distal tip 16, and
`control means 18. For the practice of the present inven
`tion, many types of catheters known in the prior art may
`be used. The control means 18, balloon 14 and distal tip
`16 may be of various designs and sizes know by those
`skilled in the art.
`Mounted on body 12, spaced apart proximally from
`balloon 14, is a wire guiding means‘ 20. In the embodi
`ment shown, it is a guidewire loop or keeper 20 which
`is mounted on catheter body 12 so as to form a guide
`wire path or lumen 22 as illustrated in the cross-sec
`tional view of FIG. 2. The catheter body 12 consists of
`a spring coil 94 with a jacket 96, of polyethylene, for
`example. Keeper 20, in this embodiment, is a partial
`cylinder of metallic or polymer material (PE, PVC, or
`similar known materials) approximately 25 cm long.
`Keeper 20 is affixed such as with glue as, for example,
`
`60
`
`65
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`

`

`Page 4 of 6
`
`20
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`5,267,958
`4
`3
`be advanced such that it rests external to keeper 66.
`with cyanoacrylate, to catheter body 12, as at location
`26. Insertion of a guidewire 24 through path 22 is illus
`Catheter 60 is now connected to guidewire 74 via
`keeper 64. Since guidewire 74 is no longer within the
`trated in FIG. 4. Guidewire 24 rides in keeper 20 just as
`occluded keeper 66, catheter 60 can be withdrawn leav
`a belt ?ts in a belt loop or buckle keeper. The guidewire
`ing guidewire 74 in place within the vessel thereby
`24 will be more pushable and track better as the length
`permitting easy exchange of catheters. Suitable lengths
`of keeper 20 increases.
`In FIG. 4, keeper 20 may be formed of the material of
`of keeper 64 and keeper 66 range from one to two cm.
`Those skilled in the art will recognize that guidewire 74
`balloon 14. A skive 23 is cut to open both ends of keeper
`will be more pushable and track better as the length of
`20. Also mounted on catheter body 12 is sheath 28.
`keeper 64 and keeper 68 increase and as additional keep
`Sheath 28 is preferably a cylinder mounted on catheter
`body 12 with a weakened slit 30 for removal by peeling,
`ei's beyond one keeper are added.
`i.e., a “peelable sheath”. The guidewire 24 will be more
`The alternative embodiment illustrated in FIG. 8
`pushable and track better as the length of keeper 20
`includes a catheter 80 with a body 82 and balloon 84.
`Mounted over catheter body 82, proximal to balloon 84
`increases.
`I
`In the preferred embodiment, sheath 28 of FIG. 3 is
`vis a long sheath 86. Sheath 86 could be mounted utiliz
`- ing a variety of techniques as, for example, adhesively,
`formed of a polymer such as PET, polyethylene or
`polyethylene copolymers. In operation, one method of‘
`frictionally or thermally. Sheath 86 materials can in
`clude, for example, biocompatible materials such as
`using catheter 10 is to insert the entire catheter with
`polyethylene, nylon or Teflon ®. Sheath 86 is peelable
`guidewire 24 loaded through a lumen 32 of sheath 28
`and through lumen 22 of keeper 20. If an exchange is
`as disclosed above. In this embodiment, guidewire 88 is
`needed, catheter 10 is withdrawn proximally along
`mounted through sheath 86. When exchange is neces
`guidewire 24. As sheath 28 is exposed outside of the
`sary, catheter 80 is withdrawn and sheath 86 is peeled
`body, sheath 28 is split and peeled away so that guide
`away from guidewire 88 as catheter 80 exits the body.
`Keepers in other embodiments such as keeper 64 could
`wire 24 is freed from its connection at that point with
`be similarly peelable.
`catheter body 12. Catheter body 12 slides along guide
`A catheter constructed according to the present in
`wire 24 by means of keeper 20. When catheter 10 is
`vention can also improve pushability by optionally hav
`outside the body, it is removed from guidewire 24. A
`ing a stylet 90 built into the catheter 10 for reinforce
`successive catheter with a keeper 20 is inserted over
`guidewire 24 and inserted into the body for the succes
`ment so that the catheter 10 can be more easily pushed
`sive therapy.
`along the external guidewire 24. The stylet 90 is a rigid
`Various combinations of sheath 28 and keeper 20 may
`wire mounted to the length of the interior wall 92 of the
`spring coil 94. Mounting can be accomplished by weld
`be used by those skilled in the art. Suggested embodi
`ing, brazing or any other technique of af?xing metal to
`ments appear in the other ?gures.
`metal. The stylet 90 could be implemented in any of the
`FIG. 5 illustrates a catheter 40 with a body 42 and a
`invention embodiments disclosed herein.
`balloon 44.
`The preceding speci?c embodiments are illustrative
`First keeper 46 is mounted on catheter body 42 proxi
`mal to balloon 44. Second keeper 48 is mounted distally
`of the practice of the invention. It is to be understood,
`to balloon 44 and catheter body 42. A guidewire 50 is
`however, that other expedients known to those skilled
`illustrated inserted through ?rst keeper 46 and second
`in the art or disclosed herein ma be employed without
`keeper 48. In this embodiment, guidewire 50 extends
`departing from the spirit of the invention or the scope of
`the appended claims.
`~past unin?ated balloon 44. For insertion, balloon 44 is
`wrapped around guidewire 50. An example of a tech
`What is claimed is:
`nique for wrapping balloon 44 is illustrated in FIG. 6.
`1. A medical catheter comprising:
`an elongate body having a proximal end and a distal
`Those skilled in the art will recognize that there are
`other positions in which balloon 44 could be wrapped
`end;
`or folded. Once catheter 40 is in place, guidewire 50
`a therapy means mounted on the body generally adja
`may be withdrawn from second keeper 48 to a position
`cent to the distal end for providing medical treat
`proximal of balloon 44 before balloon 44 is in?ated.
`ment;
`Suitable lengths of ?rst keeper 46 and second keeper 48
`a ?rst wire guiding means, mounted external to the
`body, for mounting over a guidewire, the ?rst wire
`range from one to two cm. Those skilled in the art will
`recognize that guidewire 50 will be more pushable and
`guiding means being a loop ?xedly attached to the
`body and mounted proximal to the therapy means;
`track better as the length of the ?rst keeper 46 and the
`second keeper 48 increase and as additional keepers
`and
`beyond one keeper are added.
`a second wire guiding means mounted external to the
`body for mounting over a guidewire, the second
`Another embodiment is illustrated in FIG. 7 where
`wire guiding means being a loop ?xedly attached to
`catheter 60 includes a catheter body 62 and ?rst and
`second keepers 64 and 66, respectively, both of which
`the body and mounted distal to the therapy means.
`2. A medical catheter comprising:
`are mounted proximal to balloon 68. In this embodi
`ment, keeper 64 is constructed as previously disclosed.
`an elongate body having a proximal end and a distal
`end;
`Keeper 66 has a central lumen 70 which is open to the
`proximal end of keeper 66 as discussed above. A distal
`a therapy means mounted on the body generally adja
`end 72 of keeper 66, however, is closed. In this embodi
`cent to the distal end for providing medical treat
`ment, guidewire 74 is mounted through keeper 64 and
`ment;
`through keeper 66 up against end 72. In this way, guide
`a ?rst wire guiding means, mounted external to the
`body for mounting over a guidewire, the ?rst wire
`wire 74 may be used to push catheter 60. Furthermore,
`guiding means being a loop ?xedly attached to the
`guidewire 74 may be retracted or catheter 60 advanced
`body and proximal to the therapy means, wherein
`until distal end of guidewire 74 rests in the space be
`tween keeper 64 and keeper 66. Guidewire 74 can then
`the loop is a peelable sheath;
`
`65
`
`35
`
`40
`
`45
`
`

`

`Page 5 of 6
`
`10
`
`20
`
`25
`
`5,267,958
`5
`6
`wherein the catheter is reinforced with a stiffening
`inserting a different catheter with an angioplasty
`means mounted to the body; and
`balloon over the guidewire into the body,
`in?ating the balloon,
`wherein the stiffening means is a stylet.
`3. A medical catheter comprising:
`de?ating the balloon,
`an elongate body having a proximal end and a distal
`withdrawing the catheter over the guidewire.
`end;
`8. A method of inserting a catheter on a guidewire
`comprising:
`a therapy means mounted on the body generally ad ja
`cent to the distal end for providing medical treat
`providing a catheter with an angioplasty balloon
`having a ?rst guidewire loop proximal to the bal
`ment;
`loon and a second guidewire loop proximal to the
`a ?rst wire guiding means, mounted external to the
`?rst guidewire loop;
`body, for mounting over a guidewire, the ?rst wire
`inserting the guidewire through the ?rst and second
`guiding means being a loop with an occluded distal
`guidewire loops;
`end ?xedly attached to the body and mounted
`proximal to the therapy means;
`inserting the catheter and guidewire in a human body;
`removing the guidewire from the ?rst guidewire
`a second wire guiding means being a peelable sheath
`loop;
`and mounted proximal to the ?rst wire guiding
`placing the guidewire external to the outside surface
`means.
`of the ?rst guidewire loop; and
`4. A method of inserting a catheter on a guidewire
`comprising:
`allowing the catheter to be withdrawn over the sec
`providing a catheter with an angioplasty balloon
`ond guidewire loop while maintaining access to a
`vessel being treated by keeping the guidewire in
`having a ?rst guidewire loop proximal to the bal
`place in the vessel.
`loon and a second guidewire loop distal to the
`9. The method of claim 8 wherein the step of remov
`balloon;
`'
`inserting a guidewire through the ?rst loop and the
`ing the guidewire from the ?rst guidewire loop includes
`withdrawing the guidewire.
`second loop;
`wrapping the balloon around the guidewire; and
`10. The method of claim 8 wherein the step of remov
`inserting the catheter and guidewire in the human
`ing the guidewire from the ?rst guidewire loop includes ’
`body.
`advancing the catheter.
`5. The method of claim 4, further comprising:
`11. The method of claim 8 wherein the distal end of
`withdrawing the guidewire in the proximal direction
`the ?rst guidewire loop is occluded.
`12. The method of claim 11 further comprising;
`so that the guidewire is proximal to the balloon;
`positioning the guidwire over the stenosis,
`and
`in?ating the balloon.
`inserting a different catheter with an angioplasty
`6. The method of claim 5, further comprising:
`balloon over the guidewire into the body,
`de?ating the balloon; and
`in?ating the balloon,
`de?ating the balloon,
`withdrawing the catheter over the guidewire.
`7. The method of claim 6 further comprising;
`withdrawing the catheter over the guidewire.
`positioning the guidewire over the stenosis,
`* ¥ * *
`it
`
`30
`
`35
`
`45
`
`50
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`55
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`65
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`Page 6 of 6
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENTNO. 1
`DATED
`1
`INVENTOWS) I
`
`5,267,958
`Dec. 7, 1993
`Dr. Maurice Buchbinder, et a1.
`
`It is certified that error appears in the above-indentified patent and that said Letters Patent is hereby
`corrected as shown below:
`
`Col. 4, line 39, delete "ma", add —-may--.
`
`Signed and Sealed this
`
`/
`
`Fifth Day of July, 1994
`
`Attesring O?‘icer
`
`Commissioner of Patent: and Trademarks
`
`BRUCE LEHMAN
`
`