CA2219183A1 - Method and apparatus for exchanging guide catheters - Google Patents
Method and apparatus for exchanging guide catheters Download PDFInfo
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- CA2219183A1 CA2219183A1 CA 2219183 CA2219183A CA2219183A1 CA 2219183 A1 CA2219183 A1 CA 2219183A1 CA 2219183 CA2219183 CA 2219183 CA 2219183 A CA2219183 A CA 2219183A CA 2219183 A1 CA2219183 A1 CA 2219183A1
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- catheter
- guide
- guide wire
- exchange
- exchange catheter
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Abstract
A method and apparatus for replacing a first guide catheter with a second guide catheter in a catheter system useful for angioplasty and the like. The system basically comprises a guide wire insertable in a body lumen past a lesion, a guide catheter for surrounding the guide wire and a functional catheter, such as a balloon catheter around the guide wire within the guide catheter. In order to exchange guide catheters, the functional catheter is removed, an exchange catheter is inserted into the guide catheter, the first guide catheter is withdrawn and a second guide catheter is inserted. The exchange catheter then can be removed and replaced with any desired functional catheter. The exchange catheter is tubular with a longitudinal slit through the tube wall. An introducer holds the guide wire in place, spreads the exchangecatheter slit and feeds the exchange catheter over the guide wire and allows theexchange catheter to resume the tubular shape with the guide wire coaxial therein. A
preferred guide catheter includes an elongated, longitudinally slit, flexible tube, a length of beading secured to one end of the tube and a soft tip on the other end. The soft tip end may be formed into a curve for ease of positioning the catheter in a body vessel.
preferred guide catheter includes an elongated, longitudinally slit, flexible tube, a length of beading secured to one end of the tube and a soft tip on the other end. The soft tip end may be formed into a curve for ease of positioning the catheter in a body vessel.
Description
METHOD AND APPARATUS FORXCHANGING
GUIDE CA l ll~ ;KS
FIELD OF THE INVENTION
This invention relates to methods and appal~Lus for exch~nging guide catheters in percutaneous transluminal angioplasty procedures and the like while m~ g the operative position of a guide wire.
BACKGROUND OF THE INVENTION
0 Various obstructive disorders of the circulatory system such as stenotic lesions of the arteries are often treated by percutaneous tr~n~hlmin~l angioplasty procedures.
In cardiovascular procedures such as angioplasty, generally a guide catheter is inserted into the applo~iate artery and advanced transluminally to the point where the distal tip of the guide catheter is positioned near, but just short of, the obstructive lesion to be treated. A flexible guide wire is then inserted through a lumen in the guide catheter until the distal end of the guide wire extends beyond the distal tip of the guide catheter and beyond the lesion to be treated. A catheter to be used in treatment of the obstruction, such as a balloon catheter, is then inserted with a balloon catheter lumen sliding over the guide wire until the balloon lies adjacent to the lesion. The balloon is repeatedly infl~ted and deflated to dilate the lesion. Once the desired results are obtained, the balloon catheter, guide catheter and guide wire are removed.
For a variety of reasons, it may become necessary to remove a guide catheter and replace it with a second guide catheter having different characteristics. Typically, guide catheters having different flexibility and configurations may be necessary and desirable for use with dirrelent purposes. For example, where a balloon catheter is used to dilate a lesion, followed by a stent emplacement catheter for placing a stent at the dilated lesion, different characteristics sueh as different guide catheter stiffness may be optimum. Preferably, the guide wire should remain in place during catheter exchange so that the replacement guide catheter can easily be guided to the same site in the blood vessel.
, ,' P4610 In the past, guide catheters were removed and replaced by c~ lpillg an extension on the proximal guide wire end, withdrawing the guide catheter onto the extension while very carefully m~nll~lly m~i"~ g guide wire position, then threading the distal end of a second guide catheter over the proximal guide wireextension end. Typical exchange methods using a guide wire extension are detailed by Gambale et al. in U.S. Patent No. 4,922,923. Because of the great length of the extended guide wire, often over 150 cm, great care is required to perform the exchange without inadvertently pulling the guide wire end through the lesion and out of the operative position. Further, m~int~ining the long extension in a sterile o condition during this exchange is difficult. This exchange requires closely coordinated actions by several opeldlol~.
Teirstein et al. describe, in U.S. Patent No. S,234,407, a method and device forexch~nging guide catheters in which an exchange catheter is inserted over the guide wire and inside the guide catheter lumen, the guide catheter is removed, a replacement guide catheter is inserted over the exchange catheter and the exchange catheter is removed. This is a generally effective exchange technique. However, this system requires that the exchange catheter be slid onto an elongate guide wire, or guide wire extension, from the guide wire proximal end, making h~n~lling of the components difficult. Further, with the guide wire extending along the exterior surface of the exchange catheter for at least a short distance may well interfere with sliding the guide catheter being removed over the exchange catheter and sliding the replacement guide catheter over the exchange catheter during insertion, making inadvertent movement of the guide wire away from the operative position more likely.
Thus, there is a continuing need for more effective devices and methods for replacing guide catheters during procedures such as angioplasty, that will enable accurate maintenance of guide wire position during guide catheter exchange, install the exchange catheter onto the guide wire near the guide wire midpoint during insertion, remove the exchange catheter from the guide wire near the guide wire midpoint during removal and conveniently feed the exchange catheter onto and off of the guide wire.
' P4610 SU~L~ARY OF THE INVENTION
The above noted problems, and others, are overcome by the method and apparatus of this invention that use a tubular exchange catheter having an inside diameter sufficient to freely slide over a guide wire, an exterior diameter sized to s freely side within a guide catheter and a longitudinal slit through the exchange catheter sidewall for placing the exchange catheter over the guide wire.
The exchange catheter is placed around the guide wire just proximal to a bifurcate by opening the longitudinal slit with an introducer device, detailed below, and moving the slit over the guide wire until the guide wire is coaxial with the0 exchange catheter, then allowing the slit to be closed by exchange catheter elasticity.
The position of the guide~ire in the body lurnen is m~int~ined by the introducer. A bifurcate hemostasis valve is adjusted to allow free movement of the exchange catheter therethrough while minimi7ing bleeding. Insertion of the exchange catheter will be continued until the exchange catheter tip is just distal to the guide catheter tip. The guide catheter is removed by sliding it outwardly along the e~change catheter. The replacement guide catheter is then slid inwardly over the exchangecatheter and guide wire assembly. Finally, the exchange catheter is removed and separated from the guide wire, with the guide wire position in the body lumen m~in~ined by the operator's hand.
The introducer device basically comprises a generally tubular splitter mounted in a housing on a manually grippable handle, with one side of the splitter open to allow the guide wire to be moved thereinto from the side. The guide wire position is maintained by a slot or groove in the handle sized to retain the guide wire when the guide wire is pressed into the slot. The outside wall of the splitter has a diameter just smaller than the inside diameter of the exchange catheter and is spaced from the inner wall of the housing a distance sufficient to allow a longitudinally split exchange catheter to be fed over the splitter. As the exchange catheter moves over the splitter, the lon~itudinal catheter slit is forced apart and over the guide wire. As the exchange catheter is m~ved beyond the splitter, tu~e elasticity brings the slit together with the guide wi~e inside and ~xi~l with the ~ y~
catheter.
Movement of the exchange catheter contlnues untll it ls fully lnserted, after whlch the exchange of gulde catheters descrlbed above ls accompllshed. Then, the exchange catheter ls wlthdrawn by pulllng the exchange catheter off the gulde wlre. The gulde wlre ls flxed by hand at the blfurcate. The exchange catheter ls removed by spllttlng lt over the gulde-wlre. The exchange catheter sllt ls opened to permlt the gulde wlre to be separated transversely from the exchange catheter.
A preferred exchange catheter lncludes an elongated, longitudlnally sllt, flexlble tube, a length of beading secured to the proxlmal end of the tube and a soft tip on the dlstal end of the tube. Preferably the dlstal end of the tube is formed lnto a curve to ald ln placlng the exchange catheter ln a body vessel.
~RIFF D~K1~11ON OF THF DRAWING
Detalls of the lnvention, and of preferred embodlments thereof, wlll be further understood upon reference to the drawlng, whereln:
Flgure 1 ls a perspectlve vlew of an exchange catheter lntroducer constructed ln accordance wlth the lnventlon5 Flgure 2 ls a detall perspectlve vlew ta~en from Flgure 1 and showlng a splltter devlce constructed ln accordance wlth the lnventlon;
Flgure 3 ls an end elevatlon vlew of the splltter device lllustrated ln Flgure 2;
Flgure 4 ls a flow dlagram of a gulde catheter exchange method accordlng to another aspect of the lnventlon;
Flgures 5-9 are schematlc elevatlon vlews of catheters and exchange catheter lntroducer at selected polnts durlng the exchange method;
Flgure 10 ls a perspectlve, broken vlew drawn to a larger scale of an exchange catheter constructed ln accordance wlth the lnventlon;
Flgure 11 ls a sectlonal vlew taken along llnes 11-11 of Flgure 10; and Flgure 12 ls a perspective broken vlew drawn to a larger scale of an exchange catheter constructed ln accordance wlth a variant.
DBTAILFD DB~K~ ON OF l~ KK~ EMBODIM~NTS
Referrlng to Flgure 1, there ls seen an exchange catheter lntroducer 10 havlng a handle 12 conflgured for easy grlpplng by an operator ln one hand and havlng a splltter houslng 14 at the upper end.
As ls detalled below and shown ln Figure 2 and 3, the houslng 14 has an axlal openlng 16 whereln a splltter 26 ls mounted. The houslng 14 has a slde slot 18 whlch communlcates wlth the axlal openlng 16. A conventlonal gulde wlre 20, already in place in a body lumen (not shown) can be moved lnto the splltter 26 ln openlng 16 through slot 18. A
flexlble tubular exchange catheter 22 havlng a longltudlnal sllt 38 through the tube wall ls lnserted into openlng 16 and emerges surroundlng gulde wlre 20.
A slot or groove 24, as seen ln Flgure 1, ls formed in handle 12 at a locatlon whereln gulde wlre 20 can be easlly pressed into the slot 24. Slot 24 has a width correspondlng to guide wlre 20 wldth so that the gulde wlre 20 wlll be held thereln by hand. Malntalnlng the posltlon of gulde wlre 20 at a desired locatlon ln the body lumen and, ln partlcular, preventlng lnadvertent partlal wlthdrawal of the guldewlre 20 ls often of crltlcal importance. When lnsertlon of exchange catheter 22 is completed, gulde wlre 20 can be easlly moved out of slot 24.
Splitter 26 ls a generally rectangular thln sheet of metal, stiff plastlc or the llke, conflgured to have a flrst leg 28 for embeddlng ln a slot 30 ln houslng 14 as best seen ln Flgure 3. Leg 28 ls preferably adheslvely bonded ln place.
A central portlon of splitter 26 is formed lnto an approxl-mately clrcular tube 32. The tube 32 ls not entlrely closed, so that guidewlre 20 can be sllpped sideways lnto tube 32.
The splitter 26 has a second leg 34 belng conflgured to lle agalnst an upper surface 36 of slot 18, but is preferably not bonded thereto so as to malntain a deslrable "springlness" ln the entrance lnto tube 32.
Once guldewlre 20 has been sllpped lnto tube 32, exchange catheter 22 havlng a longltudlnal sllt 38 ls pushed over tube 32 of splltter 26, to expend the lnterlor of the catheter, spreadlng slit 38 so that gulde wlre 20 becomes coaxlal wlth tube 32 as the wlre and catheter pass along the splltter. As catheter 22 exlts splltter 26 and houslng 14, sllt 38 closes due to tube elastlclty, surroundlng and contalnlng gulde wlre 20.
Once the replacement of a gulde catheter ls complete, exchange catheter 22 ls removed. Exchange catheter 22 is thus slmply pulled off the guide wire 20. The longitu-dinal slit 38 allows for removal of the exchange catheter 22 by separatlng over the guidewlre 20.
The method of placlng and removlng exchange catheter 22 and replacing one guide catheter wlth another ls detalled ln the flow dlagram of Flgure 4 and the sequentlal system dlagrams provlded ln Flgures 5-9.
Inltlally, as seen ln Flgure 5, a gulde wlre 20 has been lnserted lnto the body lumen, such as an artery 44 ~ust past a leslon 46 that has narrowed artery 44. A balloon catheter 48 may have been lnserted through a gulde catheter 50 to dllate leslon 46. A decision is made to replace gulde catheter 50 wlth a second gulde catheter havlng dlfferent characteristlcs. For example, a gulde catheter havlng a dlfferent internal lumen dlameter may be needed so that a catheter bearlng a stent can be lntroduced ln place of balloon catheter 48 to place the stent at the slte of leslon 46.
As lndlcated ln step 40 of Flgure 4 and schematlcally shown ln Flgure 5, lnltlally balloon catheter 48 ls wlthdrawn through gulde catheter 50 along gulde wlre 20, which may have an extenslon 52 added thereto lf necessary to accommodate the length of balloon catheter 48.
Once balloon catheter 48 ls fully removed, as lndlcated by step 40 of Flgure 4 and lllustrated ln Figure 6, lntroducer 10 ls emplaced ad~acent to a conventional bifurcate 55 with splltter 26 around gulde wlre 20 and a longltudlnally sllt exchange catheter 22 ls moved through the lntroducer 10 to surround the gulde wlre 20, as lndlcated ln step 54 of Figure 4 and detailed above. Guide wire 20 is firmly held in place by hand in slot 24 in handle 12 of introducer 10, as seen in Flgure 1 and lndlcated in step 56 of Figure 4.
Exchange catheter 22 is fed over splitter 26 and into guide catheter 50 until the distal end of the exchange catheter 22 extends beyond the end of the guide catheter 50 but short of lesion 46 as indicated in step 58 of Figure 4 and illustrated ln Flgure 7. Introducer 10 ls removed by sliding proximal to the beading and then removed as lndlcated ln step 59 of Flgure 4 and lllustrated ln Flgure 8. Exchange catheter 22 has an inslde dlameter sufflcient to feed smoothly over gulde wlre 20 and an outslde dlameter slzed to sllde easlly lnslde each of the gulde catheter 50 belng removed and a second gulde catheter to be emplaced.
The flrst guide catheter S0 is removed and a second gulde catheter 60 ls lnserted over exchange catheter 22 as lndlcated by double ended arrow 62 ln Flgure 8 and steps 64 and 66 of Flgure 4 ln a conventlonal manner.
The exchange catheter 22 ls then removed as shown in Flgure 9 and lndlcated by step 72 of Flgure 4. Sllt 38 ls agaln spread apart as the exchange catheter 22 ls drawn out of the gulde catheter 60. The exchange catheter 22 ls pulled at a sllght upward angle to separate from the gulde wlre 20 and be fully removed whlle the guldewlre 20 ls pulled at a sllght downward angle to separate from exchange catheter 22.
Replacement of the gulde catheter 50 wlth the gulde catheter 60 is then complete.
Any functional catheter, such as another balloon 8a catheter, a stent dellvery catheter, etc. can now be lnserted lnto the gulde catheter 60 ln a conventlonal manner, as lndicated ln step 74 of Flgure 4. The exchange ls then complete and the functlonal catheter is caused to perform lts normal functlon. Where different guide catheters having dlfferent dlameters are to be used, a conventlonal sheath may be used wlth the smaller dlameter catheters.
Flgure 10 lllustrates an exchange catheter 22A
constructed in accordance with the invention. The exchange catheter 22A lncludes an elongated tube 76, typlcally havlng a diameter of about 1.73 mm wlth a 1.22 mm axlal bore therethrough and a length of about 100 cm. Dlstal tip 78, typically havlng a length of about 1.5 mm ls formed from a soft materlal, such as PELLETHANE bonded to the stlffer material, from which the main exchange catheter body is formed. A sllt 80 ls provlded along tube 76 to cooperate wlth splltter 26 as seen in Figures 1-3.
A typlcally about 200 cm length of solld beadlng 82, typlcally havlng a dlameter of about 1 mm ls bonded to the proxlmal end of tube 76. Beading 82 is typically formed from NYLON.
The proxlmal end of tube 76 lncludes a taper 84 extendlng proxlmally from the slit slde of tube 76 and the bonded end of beadlng 82 has a taper 86 to form an angled entrance to dlrect the gulde wlre 20 lnto or out of the exchange catheter 22A. Typlcally, the entrance wlll have a dlameter between the surface of taper 86 and the edge of the entrance openlng at the sllt slde of tube 76 of about .80 mm.
8b Figure 12 illustrates an exchange catheter 22B
constructed in accordance wlth a variant. The exchange catheter 22B includes a tube 76B, a dlstal soft tip 78B, a sllt 80B, a proxlmal taper 84B, and a bonded beadlng 82B wlth an end taper 86B all as descrlbed ln con~unctlon wlth Flgure 10. However, the exchange catheter 22B lncludes a dlstal curved shape 88, with a short, straight, dlstal end 90 to aid in guldlng the exchange catheter 22B lnto the desired locatlon ln the body vessel. By rotatlng exchange catheter 22B, dlstal tlp 78B can be easily guided around bends, lnto slde channels, etc. Thls overcomes one of the problems of prlor catheters, such as that descrlbed by Tlersteln ln U.S. Patent No.
5,234,407.
For best results, curved shape 88 has a radlus of about 6 to 20 mm, dlstal soft tlp 78B has a length of about 5-12 mm and the stralght dlstal sectlon 90 beyond curved shape 88 has an overall length of from about 12 to 25 mm.
Preferably, the angle between the stralght dlstal sectlon 90 and tube 76B before the curved shape 88 ls from about 60 to 90~ with 90~ generally being optimum.
Whlle certain speclflc relatlonships, materials and other parameters have been detalled ln the above descriptlon of preferred embodlments, those can be varled, where sultable, wlth simllar results. Other applicatlons, varlatlons and ramlflcatlons of the present lnventlon wlll occur to those skllled ln the art upon readlng the present dlsclosure. Those are lntended to be lncluded wlthln the scope of thls lnventlon as deflned ln the appended clalms.
GUIDE CA l ll~ ;KS
FIELD OF THE INVENTION
This invention relates to methods and appal~Lus for exch~nging guide catheters in percutaneous transluminal angioplasty procedures and the like while m~ g the operative position of a guide wire.
BACKGROUND OF THE INVENTION
0 Various obstructive disorders of the circulatory system such as stenotic lesions of the arteries are often treated by percutaneous tr~n~hlmin~l angioplasty procedures.
In cardiovascular procedures such as angioplasty, generally a guide catheter is inserted into the applo~iate artery and advanced transluminally to the point where the distal tip of the guide catheter is positioned near, but just short of, the obstructive lesion to be treated. A flexible guide wire is then inserted through a lumen in the guide catheter until the distal end of the guide wire extends beyond the distal tip of the guide catheter and beyond the lesion to be treated. A catheter to be used in treatment of the obstruction, such as a balloon catheter, is then inserted with a balloon catheter lumen sliding over the guide wire until the balloon lies adjacent to the lesion. The balloon is repeatedly infl~ted and deflated to dilate the lesion. Once the desired results are obtained, the balloon catheter, guide catheter and guide wire are removed.
For a variety of reasons, it may become necessary to remove a guide catheter and replace it with a second guide catheter having different characteristics. Typically, guide catheters having different flexibility and configurations may be necessary and desirable for use with dirrelent purposes. For example, where a balloon catheter is used to dilate a lesion, followed by a stent emplacement catheter for placing a stent at the dilated lesion, different characteristics sueh as different guide catheter stiffness may be optimum. Preferably, the guide wire should remain in place during catheter exchange so that the replacement guide catheter can easily be guided to the same site in the blood vessel.
, ,' P4610 In the past, guide catheters were removed and replaced by c~ lpillg an extension on the proximal guide wire end, withdrawing the guide catheter onto the extension while very carefully m~nll~lly m~i"~ g guide wire position, then threading the distal end of a second guide catheter over the proximal guide wireextension end. Typical exchange methods using a guide wire extension are detailed by Gambale et al. in U.S. Patent No. 4,922,923. Because of the great length of the extended guide wire, often over 150 cm, great care is required to perform the exchange without inadvertently pulling the guide wire end through the lesion and out of the operative position. Further, m~int~ining the long extension in a sterile o condition during this exchange is difficult. This exchange requires closely coordinated actions by several opeldlol~.
Teirstein et al. describe, in U.S. Patent No. S,234,407, a method and device forexch~nging guide catheters in which an exchange catheter is inserted over the guide wire and inside the guide catheter lumen, the guide catheter is removed, a replacement guide catheter is inserted over the exchange catheter and the exchange catheter is removed. This is a generally effective exchange technique. However, this system requires that the exchange catheter be slid onto an elongate guide wire, or guide wire extension, from the guide wire proximal end, making h~n~lling of the components difficult. Further, with the guide wire extending along the exterior surface of the exchange catheter for at least a short distance may well interfere with sliding the guide catheter being removed over the exchange catheter and sliding the replacement guide catheter over the exchange catheter during insertion, making inadvertent movement of the guide wire away from the operative position more likely.
Thus, there is a continuing need for more effective devices and methods for replacing guide catheters during procedures such as angioplasty, that will enable accurate maintenance of guide wire position during guide catheter exchange, install the exchange catheter onto the guide wire near the guide wire midpoint during insertion, remove the exchange catheter from the guide wire near the guide wire midpoint during removal and conveniently feed the exchange catheter onto and off of the guide wire.
' P4610 SU~L~ARY OF THE INVENTION
The above noted problems, and others, are overcome by the method and apparatus of this invention that use a tubular exchange catheter having an inside diameter sufficient to freely slide over a guide wire, an exterior diameter sized to s freely side within a guide catheter and a longitudinal slit through the exchange catheter sidewall for placing the exchange catheter over the guide wire.
The exchange catheter is placed around the guide wire just proximal to a bifurcate by opening the longitudinal slit with an introducer device, detailed below, and moving the slit over the guide wire until the guide wire is coaxial with the0 exchange catheter, then allowing the slit to be closed by exchange catheter elasticity.
The position of the guide~ire in the body lurnen is m~int~ined by the introducer. A bifurcate hemostasis valve is adjusted to allow free movement of the exchange catheter therethrough while minimi7ing bleeding. Insertion of the exchange catheter will be continued until the exchange catheter tip is just distal to the guide catheter tip. The guide catheter is removed by sliding it outwardly along the e~change catheter. The replacement guide catheter is then slid inwardly over the exchangecatheter and guide wire assembly. Finally, the exchange catheter is removed and separated from the guide wire, with the guide wire position in the body lumen m~in~ined by the operator's hand.
The introducer device basically comprises a generally tubular splitter mounted in a housing on a manually grippable handle, with one side of the splitter open to allow the guide wire to be moved thereinto from the side. The guide wire position is maintained by a slot or groove in the handle sized to retain the guide wire when the guide wire is pressed into the slot. The outside wall of the splitter has a diameter just smaller than the inside diameter of the exchange catheter and is spaced from the inner wall of the housing a distance sufficient to allow a longitudinally split exchange catheter to be fed over the splitter. As the exchange catheter moves over the splitter, the lon~itudinal catheter slit is forced apart and over the guide wire. As the exchange catheter is m~ved beyond the splitter, tu~e elasticity brings the slit together with the guide wi~e inside and ~xi~l with the ~ y~
catheter.
Movement of the exchange catheter contlnues untll it ls fully lnserted, after whlch the exchange of gulde catheters descrlbed above ls accompllshed. Then, the exchange catheter ls wlthdrawn by pulllng the exchange catheter off the gulde wlre. The gulde wlre ls flxed by hand at the blfurcate. The exchange catheter ls removed by spllttlng lt over the gulde-wlre. The exchange catheter sllt ls opened to permlt the gulde wlre to be separated transversely from the exchange catheter.
A preferred exchange catheter lncludes an elongated, longitudlnally sllt, flexlble tube, a length of beading secured to the proxlmal end of the tube and a soft tip on the dlstal end of the tube. Preferably the dlstal end of the tube is formed lnto a curve to ald ln placlng the exchange catheter ln a body vessel.
~RIFF D~K1~11ON OF THF DRAWING
Detalls of the lnvention, and of preferred embodlments thereof, wlll be further understood upon reference to the drawlng, whereln:
Flgure 1 ls a perspectlve vlew of an exchange catheter lntroducer constructed ln accordance wlth the lnventlon5 Flgure 2 ls a detall perspectlve vlew ta~en from Flgure 1 and showlng a splltter devlce constructed ln accordance wlth the lnventlon;
Flgure 3 ls an end elevatlon vlew of the splltter device lllustrated ln Flgure 2;
Flgure 4 ls a flow dlagram of a gulde catheter exchange method accordlng to another aspect of the lnventlon;
Flgures 5-9 are schematlc elevatlon vlews of catheters and exchange catheter lntroducer at selected polnts durlng the exchange method;
Flgure 10 ls a perspectlve, broken vlew drawn to a larger scale of an exchange catheter constructed ln accordance wlth the lnventlon;
Flgure 11 ls a sectlonal vlew taken along llnes 11-11 of Flgure 10; and Flgure 12 ls a perspective broken vlew drawn to a larger scale of an exchange catheter constructed ln accordance wlth a variant.
DBTAILFD DB~K~ ON OF l~ KK~ EMBODIM~NTS
Referrlng to Flgure 1, there ls seen an exchange catheter lntroducer 10 havlng a handle 12 conflgured for easy grlpplng by an operator ln one hand and havlng a splltter houslng 14 at the upper end.
As ls detalled below and shown ln Figure 2 and 3, the houslng 14 has an axlal openlng 16 whereln a splltter 26 ls mounted. The houslng 14 has a slde slot 18 whlch communlcates wlth the axlal openlng 16. A conventlonal gulde wlre 20, already in place in a body lumen (not shown) can be moved lnto the splltter 26 ln openlng 16 through slot 18. A
flexlble tubular exchange catheter 22 havlng a longltudlnal sllt 38 through the tube wall ls lnserted into openlng 16 and emerges surroundlng gulde wlre 20.
A slot or groove 24, as seen ln Flgure 1, ls formed in handle 12 at a locatlon whereln gulde wlre 20 can be easlly pressed into the slot 24. Slot 24 has a width correspondlng to guide wlre 20 wldth so that the gulde wlre 20 wlll be held thereln by hand. Malntalnlng the posltlon of gulde wlre 20 at a desired locatlon ln the body lumen and, ln partlcular, preventlng lnadvertent partlal wlthdrawal of the guldewlre 20 ls often of crltlcal importance. When lnsertlon of exchange catheter 22 is completed, gulde wlre 20 can be easlly moved out of slot 24.
Splitter 26 ls a generally rectangular thln sheet of metal, stiff plastlc or the llke, conflgured to have a flrst leg 28 for embeddlng ln a slot 30 ln houslng 14 as best seen ln Flgure 3. Leg 28 ls preferably adheslvely bonded ln place.
A central portlon of splitter 26 is formed lnto an approxl-mately clrcular tube 32. The tube 32 ls not entlrely closed, so that guidewlre 20 can be sllpped sideways lnto tube 32.
The splitter 26 has a second leg 34 belng conflgured to lle agalnst an upper surface 36 of slot 18, but is preferably not bonded thereto so as to malntain a deslrable "springlness" ln the entrance lnto tube 32.
Once guldewlre 20 has been sllpped lnto tube 32, exchange catheter 22 havlng a longltudlnal sllt 38 ls pushed over tube 32 of splltter 26, to expend the lnterlor of the catheter, spreadlng slit 38 so that gulde wlre 20 becomes coaxlal wlth tube 32 as the wlre and catheter pass along the splltter. As catheter 22 exlts splltter 26 and houslng 14, sllt 38 closes due to tube elastlclty, surroundlng and contalnlng gulde wlre 20.
Once the replacement of a gulde catheter ls complete, exchange catheter 22 ls removed. Exchange catheter 22 is thus slmply pulled off the guide wire 20. The longitu-dinal slit 38 allows for removal of the exchange catheter 22 by separatlng over the guidewlre 20.
The method of placlng and removlng exchange catheter 22 and replacing one guide catheter wlth another ls detalled ln the flow dlagram of Flgure 4 and the sequentlal system dlagrams provlded ln Flgures 5-9.
Inltlally, as seen ln Flgure 5, a gulde wlre 20 has been lnserted lnto the body lumen, such as an artery 44 ~ust past a leslon 46 that has narrowed artery 44. A balloon catheter 48 may have been lnserted through a gulde catheter 50 to dllate leslon 46. A decision is made to replace gulde catheter 50 wlth a second gulde catheter havlng dlfferent characteristlcs. For example, a gulde catheter havlng a dlfferent internal lumen dlameter may be needed so that a catheter bearlng a stent can be lntroduced ln place of balloon catheter 48 to place the stent at the slte of leslon 46.
As lndlcated ln step 40 of Flgure 4 and schematlcally shown ln Flgure 5, lnltlally balloon catheter 48 ls wlthdrawn through gulde catheter 50 along gulde wlre 20, which may have an extenslon 52 added thereto lf necessary to accommodate the length of balloon catheter 48.
Once balloon catheter 48 ls fully removed, as lndlcated by step 40 of Flgure 4 and lllustrated ln Figure 6, lntroducer 10 ls emplaced ad~acent to a conventional bifurcate 55 with splltter 26 around gulde wlre 20 and a longltudlnally sllt exchange catheter 22 ls moved through the lntroducer 10 to surround the gulde wlre 20, as lndlcated ln step 54 of Figure 4 and detailed above. Guide wire 20 is firmly held in place by hand in slot 24 in handle 12 of introducer 10, as seen in Flgure 1 and lndlcated in step 56 of Figure 4.
Exchange catheter 22 is fed over splitter 26 and into guide catheter 50 until the distal end of the exchange catheter 22 extends beyond the end of the guide catheter 50 but short of lesion 46 as indicated in step 58 of Figure 4 and illustrated ln Flgure 7. Introducer 10 ls removed by sliding proximal to the beading and then removed as lndlcated ln step 59 of Flgure 4 and lllustrated ln Flgure 8. Exchange catheter 22 has an inslde dlameter sufflcient to feed smoothly over gulde wlre 20 and an outslde dlameter slzed to sllde easlly lnslde each of the gulde catheter 50 belng removed and a second gulde catheter to be emplaced.
The flrst guide catheter S0 is removed and a second gulde catheter 60 ls lnserted over exchange catheter 22 as lndlcated by double ended arrow 62 ln Flgure 8 and steps 64 and 66 of Flgure 4 ln a conventlonal manner.
The exchange catheter 22 ls then removed as shown in Flgure 9 and lndlcated by step 72 of Flgure 4. Sllt 38 ls agaln spread apart as the exchange catheter 22 ls drawn out of the gulde catheter 60. The exchange catheter 22 ls pulled at a sllght upward angle to separate from the gulde wlre 20 and be fully removed whlle the guldewlre 20 ls pulled at a sllght downward angle to separate from exchange catheter 22.
Replacement of the gulde catheter 50 wlth the gulde catheter 60 is then complete.
Any functional catheter, such as another balloon 8a catheter, a stent dellvery catheter, etc. can now be lnserted lnto the gulde catheter 60 ln a conventlonal manner, as lndicated ln step 74 of Flgure 4. The exchange ls then complete and the functlonal catheter is caused to perform lts normal functlon. Where different guide catheters having dlfferent dlameters are to be used, a conventlonal sheath may be used wlth the smaller dlameter catheters.
Flgure 10 lllustrates an exchange catheter 22A
constructed in accordance with the invention. The exchange catheter 22A lncludes an elongated tube 76, typlcally havlng a diameter of about 1.73 mm wlth a 1.22 mm axlal bore therethrough and a length of about 100 cm. Dlstal tip 78, typically havlng a length of about 1.5 mm ls formed from a soft materlal, such as PELLETHANE bonded to the stlffer material, from which the main exchange catheter body is formed. A sllt 80 ls provlded along tube 76 to cooperate wlth splltter 26 as seen in Figures 1-3.
A typlcally about 200 cm length of solld beadlng 82, typlcally havlng a dlameter of about 1 mm ls bonded to the proxlmal end of tube 76. Beading 82 is typically formed from NYLON.
The proxlmal end of tube 76 lncludes a taper 84 extendlng proxlmally from the slit slde of tube 76 and the bonded end of beadlng 82 has a taper 86 to form an angled entrance to dlrect the gulde wlre 20 lnto or out of the exchange catheter 22A. Typlcally, the entrance wlll have a dlameter between the surface of taper 86 and the edge of the entrance openlng at the sllt slde of tube 76 of about .80 mm.
8b Figure 12 illustrates an exchange catheter 22B
constructed in accordance wlth a variant. The exchange catheter 22B includes a tube 76B, a dlstal soft tip 78B, a sllt 80B, a proxlmal taper 84B, and a bonded beadlng 82B wlth an end taper 86B all as descrlbed ln con~unctlon wlth Flgure 10. However, the exchange catheter 22B lncludes a dlstal curved shape 88, with a short, straight, dlstal end 90 to aid in guldlng the exchange catheter 22B lnto the desired locatlon ln the body vessel. By rotatlng exchange catheter 22B, dlstal tlp 78B can be easily guided around bends, lnto slde channels, etc. Thls overcomes one of the problems of prlor catheters, such as that descrlbed by Tlersteln ln U.S. Patent No.
5,234,407.
For best results, curved shape 88 has a radlus of about 6 to 20 mm, dlstal soft tlp 78B has a length of about 5-12 mm and the stralght dlstal sectlon 90 beyond curved shape 88 has an overall length of from about 12 to 25 mm.
Preferably, the angle between the stralght dlstal sectlon 90 and tube 76B before the curved shape 88 ls from about 60 to 90~ with 90~ generally being optimum.
Whlle certain speclflc relatlonships, materials and other parameters have been detalled ln the above descriptlon of preferred embodlments, those can be varled, where sultable, wlth simllar results. Other applicatlons, varlatlons and ramlflcatlons of the present lnventlon wlll occur to those skllled ln the art upon readlng the present dlsclosure. Those are lntended to be lncluded wlthln the scope of thls lnventlon as deflned ln the appended clalms.
Claims (20)
1. A method of removing a first guide catheter extending into a body lumen around a guide wire extending through and beyond ends of said first guide catheter and replacing said first guide catheter with a second guide catheter while maintaining the position of the guide wire, which comprises the steps of:
providing a flexible tubular exchange catheter having an outside diameter less than the inside diameter of each of said first and second guide catheters and an inside diameter greater than the diameter of said guide wire and further having a longitudinal slit through a wall of said exchange catheter;
opening said slit at the distal end of said exchange catheter and feeding said slit over said guide wire so that said guide wire is substantially coaxial with said exchange catheter;
inserting said exchange catheter into said first guide catheter until the distalend of said exchange catheter is at a predetermined position relative to the distal end of said first guide catheter;
removing said first guide catheter by sliding said first guide catheter along said exchange catheter;
inserting said second guide catheter by sliding said second guide catheter along said exchange catheter until the distal end of said second guide catheter is at a predetermined position relative to the distal end of said guide wire;
sliding said exchange catheter from said second guide catheter; and separating said slit and removing said exchange catheter from said guide wire.
providing a flexible tubular exchange catheter having an outside diameter less than the inside diameter of each of said first and second guide catheters and an inside diameter greater than the diameter of said guide wire and further having a longitudinal slit through a wall of said exchange catheter;
opening said slit at the distal end of said exchange catheter and feeding said slit over said guide wire so that said guide wire is substantially coaxial with said exchange catheter;
inserting said exchange catheter into said first guide catheter until the distalend of said exchange catheter is at a predetermined position relative to the distal end of said first guide catheter;
removing said first guide catheter by sliding said first guide catheter along said exchange catheter;
inserting said second guide catheter by sliding said second guide catheter along said exchange catheter until the distal end of said second guide catheter is at a predetermined position relative to the distal end of said guide wire;
sliding said exchange catheter from said second guide catheter; and separating said slit and removing said exchange catheter from said guide wire.
2. The method according to claim 1 wherein said first guide catheter extends into said body lumen through a hemostasis valve and said exchange catheter is emplaced over said guide wire adjacent to said hemostasis valve and is inserted through said hemostasis valve.
3. The method according to claim 1 wherein said guide wire is maintained in a substantially fixed position in said body lumen during insertion and removal of said exchange catheter.
4. The method according to claim 3 wherein said guide wire position is fixed by inserting said guide wire into a device slot located adjacent to a slit opening location.
5. An exchange catheter introduction apparatus which comprises:
a handle means;
a splitter mounted on said handle including a tubular means for receiving a longitudinally slit flexible tube thereover and expanding said slit; and a longitudinal opening through said tubular means for transversely receiving a guide wire therein; and means for allowing said flexible tube to return to closed tubular configuration surrounding said guide wire as said tube is moved beyond said splitter means.
a handle means;
a splitter mounted on said handle including a tubular means for receiving a longitudinally slit flexible tube thereover and expanding said slit; and a longitudinal opening through said tubular means for transversely receiving a guide wire therein; and means for allowing said flexible tube to return to closed tubular configuration surrounding said guide wire as said tube is moved beyond said splitter means.
6. The apparatus according to claim 5 wherein said tubular means has a generally cylindrical tubular wall configuration with a substantially straight axis.
7. The apparatus according to claim 5 wherein said longitudinal opening extends along said tubular wall substantially coplanar with said straight axis.
8. The apparatus according to claim 5 wherein said splitter means comprises a continuous generally rectangular strip of material configured to have a first leg, a transition to an intermediate region formed into a tube and a further transition to a second leg, said transitions forming a narrow entrance into said tube, so that said guidewire may be moved sideways through said entrance into said tubular region.
9. The apparatus according to claim 8 wherein said first leg is fixedly secured to said handle and said second leg abuts said handle.
10. The apparatus according to claim 5 further including retaining means for releasably maintaining said guide wire in a fixed position relative to said housing.
11. The apparatus according to claim 10 wherein said retaining means comprises a groove in said handle sized to releasably retain said guide wire when said guide wire is pressed thereinto.
12. An exchange catheter introduction apparatus which comprises:
a manually grippable handle;
a splitter housing mounted on said handle;
a generally cylindrical channel through said housing;
a slot in said housing communicating from the exterior of said housing and said channel along a line generally parallel to the axis of said channel splitter means mounted on said housing and having a tubular wall substantially coaxial with said channel for receiving a longitudinally slit flexible tube thereover and expanding said slit; and a longitudinal opening through said tubular wall communicating with said slot for receiving a guide wire therein;
whereby said flexible tube is expanded over said wire and returns to tubular configuration surrounding said guide wire upon passing entirely through said splitter means.
a manually grippable handle;
a splitter housing mounted on said handle;
a generally cylindrical channel through said housing;
a slot in said housing communicating from the exterior of said housing and said channel along a line generally parallel to the axis of said channel splitter means mounted on said housing and having a tubular wall substantially coaxial with said channel for receiving a longitudinally slit flexible tube thereover and expanding said slit; and a longitudinal opening through said tubular wall communicating with said slot for receiving a guide wire therein;
whereby said flexible tube is expanded over said wire and returns to tubular configuration surrounding said guide wire upon passing entirely through said splitter means.
13. The apparatus according to claim 12 wherein said splitter means comprises a continuous generally rectangular strip of material configured to have a first leg, a transition to an intermediate region formed into a tube and a further transition to a second leg, said transitions forming a narrow entrance into said tubular regions, said entrance communicating with said slot in said housing so that said guidewire may be moved sideways through said slot and said entrance into said tubular region.
14. The apparatus according to claim 13 wherein said first leg is fixedly secured to said housing at one side of said slot and said second leg abuts an opposite side of said slot.
15. The apparatus according to claim 12 further including retaining means for releasably maintaining said guide wire in a fixed position relative to said housing.
16. The apparatus according to claim 15 wherein said retaining means comprises a groove in said handle sized to releasably retain said guide wire when said guide wire is pressed thereinto.
17. An exchange catheter comprising:
an elongated flexible tube having a longitudinal slit through a wall of said tube;
a distal tip on said elongated flexible tube, said distal tip formed from a softer material than that making up said elongated flexible tube;
an elongated length of beading having a distal end secured to the proximal end of said elongated flexible tube; and said proximal end of said elongated flexible tube and said distal end of said beading configured to provide an entrance means for directing a guide wire into and out of said proximal end of said elongated flexible tube.
an elongated flexible tube having a longitudinal slit through a wall of said tube;
a distal tip on said elongated flexible tube, said distal tip formed from a softer material than that making up said elongated flexible tube;
an elongated length of beading having a distal end secured to the proximal end of said elongated flexible tube; and said proximal end of said elongated flexible tube and said distal end of said beading configured to provide an entrance means for directing a guide wire into and out of said proximal end of said elongated flexible tube.
18. The exchange catheter according to claim 17 wherein said entrance section is formed by a taper in said proximal end of said elongated flexible tube extending from said slit and a cooperating distal end taper in said beading extending toward a side of said elongated flexible tube opposite said slit.
19. The exchange catheter according to claim 17 wherein said distal end of said elongated flexible tube is formed into a curved configuration.
20. The exchange catheter according to claim 19 wherein said curve has a radius of from about 2 to 20 mm and a straight section distal to said curve has a length of from about 12 to 25 mm, said straight section lying at an angle to said elongated flexible tube before said curve of from about 60 to 90°.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US74180296A | 1996-10-31 | 1996-10-31 | |
| US08/741,802 | 1996-10-31 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2219183A1 true CA2219183A1 (en) | 1998-04-30 |
Family
ID=24982273
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2219183 Abandoned CA2219183A1 (en) | 1996-10-31 | 1997-10-24 | Method and apparatus for exchanging guide catheters |
Country Status (2)
| Country | Link |
|---|---|
| JP (1) | JPH10151204A (en) |
| CA (1) | CA2219183A1 (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19948409C1 (en) | 1999-10-07 | 2001-04-19 | Helmut Wollschlaeger | Device for handling at least one guide wire for guiding an interventional medical instrument or for handling a catheter shaft in interventional medical techniques |
| AU2003228136B2 (en) * | 2003-04-24 | 2010-03-11 | Innovation Medical Products Holding B.V. | Device for inserting a drain and handle for such a device |
| JP5389373B2 (en) * | 2008-04-23 | 2014-01-15 | オリンパスメディカルシステムズ株式会社 | Endoscope guide wire probe, guide wire probe set, and ultrasonic endoscope |
-
1997
- 1997-10-24 CA CA 2219183 patent/CA2219183A1/en not_active Abandoned
- 1997-10-28 JP JP9295676A patent/JPH10151204A/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| JPH10151204A (en) | 1998-06-09 |
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