BSC USP 8,048,032
`Exhibit 1011
`
`Page 1 of 25
`
`United States Patent [19]
`Adams et al. (cid:9)
`
`[54]
`
`[75]
`
`INTRAVASCULAR DEVICE FOR CORONARY
`HEART TREATMENT
`
`Inventors: Daniel 0. Adams, Orono; Scott P.
`Thome, Waite Park, both of Minn.
`
`[73] Assignee: SciMed Life Systems, Inc., Maple
`Grove, Minn
`
`[21] Appi. No.: 303,590
`
`[22] Filed: (cid:9)
`
`Sep. 9, 1994
`
`Related U.S. Application Data
`
`[63] Continuation of Ser. No. 874,079, Apr. 24, 1992, abandoned,
`which is a continuation-in-part of Ser. No. 605,398, Oct. 29,
`1990, abandoned.
`[51] Int. C1.6
`[52] U.S. Cl. (cid:9)
`
` A61M 5/00
` 604/171; 604/264; 604/280;
`604/96; 604/164; 128/772
` 604/162, 163,
`[58] Field of Search (cid:9)
`604/160, 158, 159, 161, 166, 282, 283,
`93, 96, 100, 164, 171, 264, 280, 281, 284;
`128/657, 658, 772; 606/108, 119, 121
`
`[56]
`
`References Cited
`
`U.S. PATENT DOCUMENTS
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`
`(List continued on next page.)
`
`FOREIGN PATENT DOCUMENTS
`
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`0231601 8/1987 European Pat. Off. .
`
` 606/108
`
` 606/119
` 604/158
` 606/119
`
` 606/119
`
`1111111111111111111111111111111101111A1191111111111111111111111111111111
`5,527,292
`[li] Patent Number: (cid:9)
`[45] Date of Patent: (cid:9)
`Jun. 18, 1996
`
`8/1988 European Pat. Off. .
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`0397357 11/1990 European Pat. Off. .
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`
`OTHER PUBLICATIONS
`A Technique For Exchanging A Clotted Intravascular Cath-
`eter Using The Original Arteriopuncture Site-M. Leon
`Skolnick, M.D., Syracuse, New York.
`"Replacing the Occluded Percutaneous Nephrostomy Cath-
`eter", Radiology, p. 824, Dec. 1981, Baron et al.
`"Spiral Exchange Cannula for the Occluded Drainage Cath-
`eter", Radiology, pp. 541--544, Nov. 1985. McCain et al.
`"An Alternate Method for Repair of a Leaking Arterial
`Chemotherapy Infusion Catheter", Journal of Surgical
`Oncology, pp. 27-28, 1987. Burkhalter et al.
`Schneider, Inc., Product Brochure for Monorail® GEXTM,
`Copright Oct. 1990.
`USCI, Product Brochure for Probing Catheter.
`Cordis Corp., Product Brochure for The Cordis ShuttleTM
`Catheter (2 pages), Copyright Dec. 1990.
`
`Primary Examiner-Corrine M. Maglione
`Assistant Examiner-Ronald K. Stright, Jr.
`Attorney, Agent, or Firm-Kinney & Lange
`
`[57] (cid:9)
`ABSTRACT
`An intravascular device having an elongated flexible tube
`sized for insertion into a coronary vessel beyond a distal end
`of a guide catheter. In use, the flexible tube has its proximal
`end within a guide catheter and has its distal end extending
`to a treatment site in a coronary artery. The device also
`including a push rod attached to a proximal end of the
`flexible tube to facilitate placement of the flexible tube
`within the coronary artery requiring treatment. In certain
`applications, the intravascular device is used as a drug (or
`other fluid) delivery device or as an aspiration device. In
`other applications, the intravascular device is used as a
`guiding means for placement of an angioplasty device, such
`as a guide wire or a balloon catheter. Additionally, an
`attachment tube may be provided which is designed to
`couple with a proximal end of the flexible tube to provide a
`continuous conduit for aspiration or fluid delivery to a
`treatment site in a coronary artery.
`
`41 Claims, 10 Drawing Sheets
`
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`Page 2 of 25
`
`5,527,292
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`4,345,596
`4,354,491
`4,369,790
`4,412,832
`4,449,532
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`4,581,019
`4,581,025
`4,616,652
`4,619,644
`4,631,059
`4,687,469
`4,696,667
`4,723,948
`4,726,369
`4,747,833
`4,748,982
`4,771,777
`4,801,294
`4,827,941
`
`8/1982 Young .
`10/1982 Marbry .
`1/1983 McCarthy (cid:9)
`11/1983 (cid:9) Kling et al. .
`5/1984 (cid:9) Storz
`8/1985 (cid:9) Gold (cid:9)
`4/1986 (cid:9) Sahota .
`4/1986 (cid:9) Curelaru et al. .
`4/1986 Timmermans .
`10/1986 (cid:9) Simpson .
`10/1986 (cid:9) Scott .
`12/1986 (cid:9) Wolvek et al. .
`10/1987 (cid:9) Osypka .
`9/1987 Masch (cid:9)
`2/1988 (cid:9) Clark et al. (cid:9)
`2/1988 (cid:9) Mar .
`5/1988 (cid:9) Kousai et al. .
`6/1988 (cid:9) Horzewski et al. .
`9/1988 (cid:9) Horzewski et al. .
`1/1989 (cid:9) Okada .
`5/1989 (cid:9) Taylor et al. .
`
`
`
`
`
`
`
`
`604/280
`
`128/772
`
`604/53
`604/283
`
`4,842,590
`4,858,810
`4,863,439
`4,886,500
`4,905,667
`4,909,258
`4,929,236
`4,932,413
`4,944,740
`4,947,864
`4,969,890
`4,976,689
`4,988,356
`4,994,027
`4,998,923
`5,002,559
`5,035,686
`5,078,702
`5,120,323
`5,135,535
`5,147,377
`5,178,608
`
`6/1989
`8/1989
`9/1989
`12/1989
`3/1990
`3/1990
`5/1990
`6/1990
`7/1990
`8/1990
`11/1990
`12/1990
`1/1991
`2/1991
`3/1991
`3/1991
`7/1991
`1/1992
`6/1992
`8/1992
`9/1992
`1/1993
`
`Tanabe et al. (cid:9)
`Intekofer et al. .
`Sanderson (cid:9)
`Lazarus (cid:9)
`Foerster et al..
`Kuntz et al. .
`Sampson .
`Shockey et al. .
`Buchbinder et al. .
`Shockey et al. .
`Sugita et al. .
`Buchbinder et al. .
`Crittenden et al. .
`Farrell.
`Sampson et al..
`Tower (cid:9)
`Crittenden et al. .
`Pomeranz (cid:9)
`Shockey et al. (cid:9)
`Kramer (cid:9)
`Sahota (cid:9)
`Winters (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`604/282
`
`604/93
`128/772
`
`128/772
`
`604/282
`604/282
`604/194
`128/772
`604/101
`
`

`

`Page 3 of 25
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`U.S. Patent (cid:9)
`
`Jun. 18, 1996 (cid:9)
`
`Sheet 1 of 10 (cid:9)
`
`5,527,292
`
`

`

`US. Patent
`
`Jun. 18, 1996
`
`Sheet 2 of 10
`
`5,527,292
`
`QM;VN
`
`m.mwmw
`
`.Iv.
`
`41.1le
`
`QM)fibrilllanuulivlllItuulllullulluusll:Illinlullnus...III
`
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`mm,wfiEiwmi!
`
`MHMxNNuWu--«._.--.m»...:-::mm:--mw.,.:-:::::-:.fi/Vriuiiw.fl3N“cmE\vQ.EN
`
`0lhlvk$mewt
`II.l'u'|'III"
`
`Page4of25
`
`Page 4 of 25
`
`U.S. Patent
`
`Sheet 2 of 10
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`5,527,292
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`

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`Page 5 of 25
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`U.S. Patent
`
`Jun. 18, 1996
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`Sheet 3 of 10
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`5,527,292
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`(cid:9)
`(cid:9)
`(cid:9)
`

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`Page 6 of 25
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`U.S. Patent (cid:9)
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`Jun. 18, 1996 (cid:9)
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`Page 7 of 25
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`Jun. 18, 1996 (cid:9)
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`Sheet 5 of 10 (cid:9)
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`Page 8 of 25
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`U.S. Patent (cid:9)
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`Jun. 18, 1996 (cid:9)
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`Sheet 6 of 10 (cid:9)
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`O
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`Page 9 of 25
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`Jun. 18, 1996
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`Page 12 of 25
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`U.S. Patent (cid:9)
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`Jun. 18, 1996 (cid:9)
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`Sheet 10 of 10 (cid:9)
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`5,527,292
`
`ti
`
`11
`11
`11
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`11
`11
`
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`
`

`

`Page 13 of 25
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`5,527,292
`
`1
`INTRAVASCULAR DEVICE FOR CORONARY
`HEART TREATMENT
`
`This is a file wrapper continuation of application Ser. No.
`07/874,079, filed Apr. 24, 1992, now abandoned, which is a
`continuation-in-part of U.S. patent application Ser. No.
`07/605,398, filed Oct. 29, 1990, now abandoned.
`
`5
`
`10
`
`2
`independently of the wire, and the wire can remain in place
`to guide a substitute catheter to the treatment site. In a
`non-over-the-wire catheter the entire catheter is withdrawn
`during a catheter exchange so the tortious path to the
`treatment site must be retraced.
`The condition of the patient may also be affected by
`thrombolytic buildup which can also occlude the lumen of
`the artery. Thrombolytic buildup results from platelet found
`in red blood cells which is thought to promote coagulation.
`In a healthy artery, endothohelial cells produce substances
`that inhibit platelet. Thus, there is a propensity for throm-
`bolytic buildup at the diseased site in an artery. Further
`stagnation of the blood flow and platelet during angioplasty
`increases the risk of thrombolytic buildup.
`Thrombolytic drugs and agents are generally used to
`dissolve the blood clot caused by the "build up" of platelet
`matter and to reverse the build up of the platelet matter.
`Alternatively, aspiration is another technique for treating
`thrombus "build up". It is important that the thrombolytic
`drugs or other treatment be administered before blood flow
`through the artery is completely or significantly restricted.
`Furthermore, thrombolytic drugs are generally extremely
`expensive so it is desirable that the drug be administered
`effectively and efficiently without waste.
`Accordingly, it is important to be able to selectively
`provide a means for efficiently introducing a thrombolytic
`agent into the diseased artery during a balloon dilatation
`procedure. Also, if necessary it is desirable to be able to
`30 easily substitute one size catheter for a different size catheter
`if the original catheter inserted can not properly dilate the
`lesion.
`
`SUMMARY OF THE INVENTION
`
`BACKGROUND OF THE INVENTION
`The present invention relates to the field of treatment of
`heart disease. In particular, the present invention relates to
`an intravascular device, particularly suited for use for per-
`cutaneous transluminal treatment for heart disease.
`A normal artery is composed of essentially, three layers, 15
`the intima, the media and the adventitia. The intima is the
`innermost layer of the artery. It is composed of a thin layer
`of endothelial cells that provide a smooth surface between
`the blood and an interior wall of the artery. The media is an
`intermediate layer which is separated from the intima by an zo
`internal elastic membrane, which allows material to diffuse
`through the intima and into the medial tissue. The media is
`a muscle layer composed of a network of smooth muscle
`cells. The smooth muscle cells of the media contract and
`relax to regulate vessel tone which in turn affects blood 25
`pressure and local blood flow. The outermost layer or
`adventitia is composed of a connective tissue and scattered
`smooth muscle cell bundles.
`Atherosclerosis is a disease which affects a normal artery
`restricting the function of the artery. Atherosclerosis
`involves the gradual build up over time of atherocelerotic
`plaque or atheroma. Atherocelerotic plaque buildup begins
`in the intimal layer of the artery and progresses with the
`deposit of fatty debris from the blood through the endothe-
`lium. As the formation progresses, the endothelium becomes
`irregular and the artery constricts because of the build up of
`the plaque. The build up is so significant that the plaque now
`diminishes the effectiveness or area of the artery.
`Balloon dilatation angioplasty has become recognized as
`an efficient and effective method for treating atherocelerotic
`buildup in coronary arteries. A dilatation balloon catheter is
`inserted preferably into the femoral artery of the patient and
`it is advanced to the obstructed area of the coronary artery.
`The balloon is inflated to compress the plaque against the
`artery wall and also to stretch the artery to dissect the plaque
`and open the artery thereby permitting an acceptable artery
`blood flow.
`Before an angioplasty procedure is performed, radiogra-
`phy is used to survey the extent of damage or disease present
`in the artery. Dilatation balloon catheters are rated for
`different functions depending on the extent to which the
`artery is occluded or obstructed by plaque and the stage to
`which the atherocelrotic deterioration has progressed.
`However, often times, the nature and extent of the damage
`is not apparent from the pre-angioplasty analysis and it is
`necessary to substitute the original balloon catheter inserted
`for an alternate sized balloon catheter. This process is
`generally referred to as a catheter exchange. A catheter
`exchange becomes a very arduous procedure if it is neces-
`sary to retrace the second catheter through the tortious
`anatomy (i.e., through a coronary artery) of a patient to
`position the balloon at the occluded area.
`There are generally two type of balloon catheters, over-
`the-wire catheters and non-over-the wire-type catheters. In
`an over-the-wire catheter, the wire is slidably disposed
`within the catheter so that the catheter may be withdrawn
`
`35 (cid:9)
`
`The present invention relates to a catheter system for
`treating coronary heart disease. In particular, the present
`invention relates to an intravascular device suited for use
`during angioplasty treatment. The device is sized for inser-
`tion through a coronary artery to reach an occluded area for
`40 treatment. Although use of the device is explained with
`reference for treating coronary arteries it should be under-
`stood that the device may also be used for treating other
`diseased vessel in a patient.
`The intravascular device includes a relatively flexible tube
`45 having a proximal and a distal end. The tube is designed to
`extend from a distal end of a guide catheter through a
`coronary artery requiring treatment. A push rod is attached
`to a proximal end of the tube for slidably positioning the
`tube beyond a distal end of a guide catheter into and through
`the artery. The flexible tube has an inner diameter sized for
`insertion over an angioplasty device.
`The tube of the intravascular device has sufficient flex-
`ibility to provide for trackability of the flexible tube through
`the tortuous coronary arteries. Thus, the relatively flexible
`tube may be advanced into an artery until the distal end
`thereof is positioned at a treatment site.
`Since the tube is flexible, the tube is not very pushable.
`The flexible tube may be advanced over an angioplasty
`60 balloon catheter or other coronary treatment device to pro-
`vide pushability for placement of the flexible tube through
`the artery. The inner diameter of the flexible tube is larger
`than the outer diameter of a typical angioplasty balloon
`catheter or other coronary treatment device.
`It is contemplated, that the intravascular device may be
`used for the placement of an angioplasty balloon catheter or
`alternatively a guide wire into a coronary artery requiring
`
`50
`
`55
`
`65 (cid:9)
`
`

`

`Page 14 of 25
`
`5,527,292
`
`3
`treatment. Furthermore, the intravascular device is particu-
`larly suited for use during a catheter exchange or a guide
`wire exchange.
`Also the intravascular device may be used for drug
`treatment to relieve thrombolytic build-up in a coronary
`artery. Since the intravascular device is inserted into and
`through the coronary artery, it provides a conduit for drug
`delivery thereto. Thrombolytic drugs may be delivered to a
`treatment site in combination with a guide catheter and the
`intravascular device. Additionally, the drugs may be deliv-
`ered in combination with a proximal drug delivery attach-
`ment. The proximal drug delivery attachment includes an
`elongated attachment tube designed for placement through a
`guide catheter. The drug delivery attachment also includes a
`coupling means for fluidly sealing the attachment tube
`relative to the proximal end of the intravascular device to
`define a continuous lumen therealong for drug delivery.
`In addition, the intravascular device may be used for
`aspirating thrombus from a coronary vessel. Again, since the
`intravascular device is inserted into and through the coro-
`nary vessel requiring treatment, the intravascular device
`provides a conduit, in combination with a guide catheter, for
`pulling a net negative pressure for withdrawing thrombus
`from the vessel. Alternatively, net negative pressure may be
`applied in combination with a proximal attachment tube and
`the intravascular device for aspiration treatment.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`5 (cid:9)
`
`10
`
`4
`FIG. 12 is an illustrative view of the distal extension of
`FIG. 9 and the guide catheter relative to the aortic arch, a
`coronary ostium and coronary artery for placement of angio-
`plasty devices into an occluded vessel for treatment.
`FIG. 13 is a broken-away perspective view of a guide
`catheter system including the distal extension of FIG. 9 for
`placement of a guide wire.
`FIG. 14 is an elevational view of a proximal elongated
`attachment tube of the present invention.
`FIG. 15 is an elevational view of the distal extension
`(intravascular device) shown coupled with the proximal
`elongated attachment tube of FIG. 14.
`FIG. 16 is a transverse view, in partial cross-section, of
`15 the distal extension coupled with the proximal elongated
`attachment tube of FIG. 14.
`FIG. 17 is an elevational view of a guide catheter system
`including the distal extension (intravascular device) of FIG.
`9 and the proximal elongated attachment tube of FIG. 14.
`20 While the above identified drawing figures set forth
`several preferred embodiments, other embodiments of the
`present invention are also contemplated, as noted in the
`discussion. In all cases, this disclosure presents illustrated
`embodiments of the present invention by way of represen-
`25 tation and not limitation. It should be understood that
`numerous other modifications and embodiments can be
`devised by those skilled in the art which fall within the scope
`and spirit of the principles of this invention, It should be
`noted that the figures have not been drawn to scale as it has
`30 been necessary to enlarge certain portions for clarity.
`
`The invention will be further described with reference to
`the accompanying drawings where like numbers refer to like
`parts in several views and wherein:
`FIG. 1 is a broken-away perspective view of an embodi-
`ment of the guide catheter system of the present invention 35
`shown with a dilatation balloon in an inflated position.
`FIG. 2 is a transverse view in partial cross section of one
`embodiment of the guide catheter extension tube (distal
`extension) of FIG. 1.
`FIG. 3 is a transverse view in partial cross section of
`another embodiment of the guide catheter extension tube
`(distal extension) of FIG. 1, the extension tube including a
`restriction balloon, which is shown in an inflated condition.
`FIG. 4 is a sectional view as taken on line 4-4 of FIG.
`3 showing the restriction balloon in an inflated condition.
`FIG. 5 is a transverse view in partial cross section of the
`guide catheter extension tube (distal extension) of FIG. 3
`with the restriction balloon shown in a deflated condition.
`FIG. 6 is a sectional view as taken on line 6-6 of FIG.
`5 showing the restriction balloon in a deflated condition.
`FIG. 7 is a broken-away perspective view of another
`embodiment of the guide catheter system of the present
`invention with a dilatation balloon shown in an inflated
`condition.
`FIG. 8 is a broken-away perspective view of another
`embodiment of the guide catheter system of the present
`invention with a dilatation balloon shown in an inflated
`condition.
`FIG. 9 is an elevational view of an, alternate embodiment
`of a distal extension (intravascular device), similar to FIGS.
`2-6.
`FIG. 10 is a perspective view, in partial cross-sectional, of
`the distal extension of FIG. 9.
`FIG. 11 is a cross-sectional view as taken along lines
`11-11 of FIG. 9.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`45 (cid:9)
`
`55
`
`The invention is directed to the structure and use of a
`distal extension (intravascular device) for a guide catheter.
`Quite often, after a dilatation balloon catheter is inserted into
`a patient, it is necessary to withdraw the balloon catheter to
`40 substitute- an alternate sized balloon catheter. This is done
`during a catheter exchange. This invention allows relatively
`easy and accurate exchanges for "non-over-the-wire" cath-
`eters, guide wires and other coronary treatment devices and
`is disclosed in several alternative embodiments.
`The distal extension (intravascular device) for the guide
`catheter disclosed may also be used for drug delivery to a
`treatment site. The distal extension disclosed has a small
`outer diameter sized for insertion through the arterial system
`of a patient beyond a distal end of the guide catheter into a
`50 coronary artery. The distal extension is formed of a rela-
`tively flexible tube to permit the extension to track through
`the tortuous coronary arteries to a treatment site. Since the
`extension reaches a treatment site, it may be used to provide
`a conduit for applying negative pressure for aspirating
`thrombus from a diseased coronary vessel.
`Specifically, the guide catheter is inserted at the femoral
`artery and advanced through a patient's arterial system to the
`coronary ostium of the artery requiring treatment. The
`construction of the guide catheter (diameter and rigidity)
`60 does not permit the guide catheter to advance beyond the
`ostium into the artery requiring treatment. The distal exten-
`sion however is designed for insertion through coronary
`arteries requiring treatment. Thus, the distal extension may
`be advanced into and through the coronary arteries to the
`lesion or obstruction to facilitate original placement of
`angioplasty devices by serving to anchor the guide catheter
`at the coronary ostium of the vessel requiring treatment for
`
`65
`
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`

`Page 15 of 25
`
`5,527,292
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`5
`
`5
`placement of an angioplasty device or other coronary treat-
`ment device into the vessel (e.g., guide wire placement and
`angioplasty balloon catheter placement) and to provide a
`less difficult means for performing guide wire exchanges
`and "non-over-the-wire" catheter exchanges and alternately
`to provide a means for delivering drugs or providing nega-
`tive pressure to a treatment site.
`It is understood that the embodiments of the present
`invention are illustrative, and should not be construed to
`limit the scope of the invention. In a first embodiment the to
`distal extension (intravascular device) is shown in associa-
`tion with a guide catheter system 10 (FIG. 1). The guide
`catheter system 10 includes a guide catheter 12, a guide
`catheter extension 14 and a guide catheter manifold 16 (FIG.
`1). (cid:9)
`The guide catheter manifold 16 is mounted at the proxi-
`mal end of the guide catheter 12. Preferably, the guide
`catheter manifold 16 comprises a Y-shaped structure having
`a primary channel leg 17 and an extension leg 15 with a
`guide catheter port 22 on the extension leg 15. The guide
`catheter port 22 provides an inlet injection port into the
`guide catheter 12. Dye is injected into port 22, (from a fluid
`source—such as a syringe) and travels through the guide
`catheter system 10 to reach the stenosis. Alternatively, port
`22 may be used to introduce drugs (i.e., thrombolytic drugs)
`through the guide catheter 12 or to apply negative pressure
`for aspiration. A hemostasis valve (not shown) on channel
`leg 17 provides hemostatic control for the guide catheter
`system 10 of the present invention.
`The guide catheter 12 is an elongated, flexible, tubular
`member defining a first guide catheter lumen 27 there-
`through. Guide catheter 12 is preferably formed of a poly-
`urethane tube. The guide catheter 12 may be preformed in
`various shapes to facilitate its passage to the coronary
`ostium or region within the body where the stenosis is
`located.
`The guide catheter extension (distal extension) 14 com-
`prises an elongated flexible tube 32 defining a second guide
`catheter lumen 33 and a shaft 19 or a push rod. The
`elongated flexible tube 32 is preferably formed from a soft,
`flexible material such as polyolefin, polyethylene or poly-
`urethane and has a rounded distal tip 36 to facilitate insertion
`and trackability through the coronary arteries. The tube 32
`may be loaded with barium sulfate or other suitable material
`to provide radiopacity. The inner surface of the elongated
`flexible tube is coated with silicone to provide a slippery
`surface. Preferably, the elongated flexible tube 32 is formed
`of a coil spring 40 made from stainless steel or a platinum
`alloy to provide radiopacity under fluoroscopy (see FIG. 2).
`An outer coating of plastic is then added around the coil
`spring 40 using a heat shrink or some similar manufacturing
`technique to define the tube 32.
`If desired, the elongated flexible tube 32 may include one
`or more holes 42 (FIG. 2) in the sidewall thereof to facilitate
`the passage of dye from the elongated flexible tube 32 into
`the artery and to also allow blood from the artery to flow into
`and through lumen 33 and out the distal end to facilitate
`distal artery perfusion. However, holes 42 prohibit use of the
`tube 32 as a drug delivery device for transport of drugs into
`the coronary arteries to a treatment site. The length of the
`elongated flexible tube 32 is preferably approximately 6 to
`10 inches.
`The outer diameter of the elongated flexible tube 32 is
`smaller than the first guide catheter lumen 27 defined by the 65
`guide catheter 12 so that it may be slidably disposed
`therethrough and to permit insertion of the tube 32 into the
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`coronary arteries. As seen in FIG. 1, shaft 19 or push rod is
`attached to a proximal end of the elongated flexible tube 32
`and extends proximally therefrom outside the guide catheter
`12 so that it is accessible to the user. The shaft 19 allows the
`user to position the guide catheter extension 14 (distal
`extension) within the patient by either extending or retract-
`ing the length of the shaft 19 to advance the guide catheter
`extension 14 as necessary. The elongated flexible tube 32 of
`the guide catheter extension 14 is designed to extend beyond
`a distal end of the guide catheter 12 into the coronary
`arteries.
`Alternate embodiments for a guide catheter extension
`(distal extension) having an elongated flexible tube and a
`shaft attached thereto are shown in FIGS. 2-6. One embodi-
`ment is shown in FIG. 2, and the shaft 19 or push rod is
`defined by an elongated wire 34. The elongated wire 34 is of
`small diameter, preferably 0.010 to 0.016 of an inch in
`diameter. As discussed, the length of the elongated wire 34
`is designed to extend from the elongated flexible tube 32
`outside the patient so that it is accessible to the doctor or
`other user. Accessibility of the elongated wire 34 permits the
`doctor to adjust the extension length of the flexible tube 32
`relative to the guide catheter 12 to position the flexible tube
`32 in the coronary arteries.
`In the embodiment shown in FIG. 2, the elongated tube 32
`has a radially flared proximal end 38. The flared proximal
`end 38 of the elongated flexible tube 32 is configured to
`coincide with the inner diameter of the guide catheter 12 so
`that a catheter advanced, or other angioplasty device such as
`a guide wire, into and through the first guide catheter lumen
`27 is piloted into the flared tip 38 and second guide catheter
`lumen 33. The close fit of the flared proximal end 38 to the
`inner diameter of the first guide catheter lumen 27 also
`directs fluid (such as dye or drugs for treatment) injected into
`the guide catheter 12 through the second guide catheter
`lumen 33 of the guide catheter extension 32. The extension
`length of the elongated flexible tube 32 is lengthened by
`advancing the wire 34 distally into the guide catheter 12 and
`into the patient. The length of the flexible tube 32 may be
`completely extended by advancing the elongated 34 wire
`until the flared proximal end 38 of the guide catheter
`extension 14 is just proximal to a distal tip 20 of the guide
`catheter 12.
`An optional radiopaque marker 41 of a platinum alloy
`may be placed on the proximal end of the extension tube 32
`just distal to the flared proximal end 38 to give fluoroscopic
`imaging of the position of the flared proximal end 38 of the
`tube 32 relative to the distal tip 20 of the guide catheter 12.
`Additionally, a radiopaque marker 43 may be placed just
`proximal to the rounded distal tip 36 of the guide catheter
`extension tube 32 to located the distal end thereof during
`operation. Another alternative is to place a visual mark 31
`(FIG. 1) on shaft 19 outside the body that indicates a
`maximum advancement position of the extension tube 32 to
`prevent passage of the flared proximal end 38 beyond the
`distal tip 20 of the guide catheter 12.
`The use of the elongated wire 34 to adjust the extension
`length of the elongated flexible tube 32 provides several
`advantages. The rather thin dimension of the wire 34 elimi-
`nates or substantially reduces surface friction introduced by
`the longitudinal movement of an element within the guide
`catheter 12. Reduced frictional force allows greater ease in
`extending and retrieving the guide catheter extension 14.
`Also, the thin diameter of the wire 34 does not significantly
`interfere with the flow of dye or other fluid through the guide
`catheter 12.
`Alternatively, there is shown in FIGS. 3-6 another
`embodiment of a guide catheter extension 14A (distal exten-
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`sion) having an elongated flexible tube 32A connected to a
`shaft 19A or push rod. The guide catheter extension 14A is
`operable with a guide catheter 12A which has a longitudinal
`guide catheter lumen 27A. The guide catheter extension 14A
`in turn has a longitudinal guide catheter extension lumen 5
`33A therethrough, a rounded distal tip 36A and may be
`reinforced by a coil 40A. If desired, one or more holes 42A
`are provided for dye introduction and distal blood perfusion.
`Also, radiopaque markers 41A and 43A are included at the
`proximal and distal ends of the tube 32A respectively to to
`provide fluoroscopic imaging of the position of the tube 32A
`relative to the guide catheter 12A.
`The shaft 19A or push rod in this embodiment comprises
`a tubular shaft member 172 which extends proximally from
`a proximal end of the elongated flexible tube 32A outside the 15
`patient so that it is accessible to the user to continually adjust
`the extended length of the elongated flexible tube 32A
`relative to the guide catheter 12A. The tubular shaft member
`172 is preferably formed from stainless steel hypotube with
`an inside diameter of 0.010 inch and an outside diameter of 20
`0.016 inch.
`The tubular shaft member 172 has a flattened distal end
`which assumes an elongated cross-section as shown in
`FIGS. 4 and 6. The flattened distal end provides sufficient
`surface area to secure the tubular shaft member 172 to the
`proximal end of the elongated flexible tube 32A, preferably
`by an epoxy bond 176. The tubular shaft member 172
`includes a proximally placed inlet port 171 (FIG. 3) which
`is mounted to a luer fitting (not shown), a distally placed
`outlet port 174 defined by the flattened cross-section and an
`inflation lumen 178 therethrough. One or more side holes
`175 (FIGS. 4 and 6) may be included to define additional
`distal outlet ports for the tubular shaft member 172.
`An expandable restriction balloon 170 is wrapped about
`the proximal end of the elongated flexible tube 32A. The
`restriction balloon 170 extends around the proximal end of
`the elongated flexible tube 32A as well as the flattened distal
`end of the tubular shaft member 172 attached to the elon-
`gated flexible tube 32A. The restriction balloon 170 is
`bonded to the elongated flexible tube 32A and the tubular
`shaft member 172 by a proximal annular bond 182 and a
`distal annular bond 184. The restriction balloon 170 is
`preferably formed of a polyolefin. Its position about the
`flattened distal end of the tubular shaft member 172 and side
`holes 175 (if included) places the restriction balloon 170 in
`fluid communication with the inflation lumen 178 of the
`tubular shaft member 172. The inlet port 171 of the tubular
`shaft member 172 is connected to an inflation device (not
`shown) which provides inflation medium to inflate the
`restriction balloon 170 connected thereto.
`In operation, the restriction balloon 170 is inflated to press
`against an inner surface wall of the guide catheter 12A. The
`friction caused by the restriction balloon's 170 interaction
`with the inner surface wall of the guide catheter 12A serves 55
`to inhibit longitudinal movement of the elongated flexible
`tube 32A through the guide catheter lumen 27A of guide
`catheter 12A. Accordingly, when the extension length of the
`elongated flexible tube 32A is properly positioned, the
`restriction balloon 170 is inflated to prohibit the retraction or 60
`advancement of the elongated flexible tube 32A through a
`distal opening 152 of the guide catheter 12A to hold the
`elongated flexible tube 32A in position during a catheter
`exchange procedure or while the extension is in use as a drug
`delivery device (FIGS. 3 and 4).
`Alternatively, when the restriction balloon 170 is deflated
`(FIGS. 5 and 6), it no longer restricts movement of the
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`8
`elongated flex