CA2167164A1 - Improved angioplasty apparatus and process - Google Patents
Improved angioplasty apparatus and processInfo
- Publication number
- CA2167164A1 CA2167164A1 CA002167164A CA2167164A CA2167164A1 CA 2167164 A1 CA2167164 A1 CA 2167164A1 CA 002167164 A CA002167164 A CA 002167164A CA 2167164 A CA2167164 A CA 2167164A CA 2167164 A1 CA2167164 A1 CA 2167164A1
- Authority
- CA
- Canada
- Prior art keywords
- balloon
- wires
- force focusing
- stenosis
- proximal
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22001—Angioplasty, e.g. PCTA
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1084—Balloon catheters with special features or adapted for special applications having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
Abstract
Improvement in balloon angioplasty is realized by a plurality of longitudinal force focusing means (1) around the balloon (3).
Description
2 ~ 6~ 6 ~ PCT/US94/07711 IMPROVED ANGIOPLASTY APPARATUS AND PROCESS
RACKGI~OUND OF INYh l~TION
Arteriosclerosis has long been a serious cardiovascular problem, 5 involving the ~ccllm~ tion of deposits or plaque on the interior walls of blood vessels, prim~rily arteries. ~ccllm~ tinn of such plaque can result in areas of the blood vessel in which a significant portion of the flow is blocked. Such significant blockage is char~stPri7Pcl as a stPnor,i~, which causes reduced flowthrough the blood vessel.
In the past, serious stenoses could generally be alleviated only by bypassing of the blood vessel. More recently, angioplasty techniques were developed to open stenoses in arteries. In such techniques, a balloon ç~thPtPr is typically inserted in the blood vessel, and the balloon is positioned at the site of the stenosis. Upon inflation, the balloon presses radially on deposited plaque at the site and on the blood vessel wall behind the plaque. Plaque deposits are often irregular in transverse cross-section. Thick portions inl~,rel~ with the ullir~
expansion of the balloon, and are, in their composition, non-uniform. These considerations increase the possibility of damage to the artery walls. It has previously been suggested to use a guide wire outside of and parallel to a catheter balloon to produce a crack in heavily calcified plaque, giving improved results and larger openings with less pl`eS~iUIe and damage. Such techniques were previously used when normal balloon p,e~ ,u~e did not s~ti~f~rtorily dilate the vessel.
Still other techniques for improving angioplasty tre~tment include the suggestion of lon~it~ in~l cutting strips f~etel~ecl on the balloon wall.
Fxp~n~ion of the balloon forces these edges ou~w~d radially to cut into the plaque. Such cutting edges seriously reduce the flexibility of the balloon, and increase the crossing profile. These r~lu,es impose limit~tions on the ability to position the device in tortuous vessels.
Still other in,l.,we",ents in angioplasty techniques involved the balloon itself, providing balloons with improved burst pressure and strength char~qctPri~tics balanced such that a balloon, if failure occurred, would burst in the lon~ in~l or axial direction as opposed to the transverse direction, facilit~tin~
removal under such circllm~t~nr,çs.
WO 95/02364 2 1, 6~1 ~s ~ ~ PCTtUS94/07711--A con~ need exists for angioplasty d~aldlus and techniques that balance the effective opening of the stenosis, minim~l damage to the wall of the blood vessel, and ~in;~ ;on of the reformation of the stenosis after completion of the angioplasty.
SUMMARY OF INYli NTION
The present invention provides an improvement in angioplasty techniques using balloon G~th~tPr~ which improves the efficiency and safety of the procedure and, in addition, tends to inhibit restenosis or subsequent build up ofplaque.
Specifically, the instant invention provides, in an angioplasty a~p~dlus comprising a balloon catheter for applying radial pressure to an arterial stenosis, the improvement wherein the appdldllls further comprises at least 2 lon~itll-lin~l force distributing means positioned radially exterior to the balloon.
The invention further provides an improved process for balloon angioplasty in which a balloon ç~th~ter is inserted into an artery, the balloon positioned at the site of a stenosis, and the balloon Iqxp~n~le(l to increase the size of the channel through the stenosis, the improvement cornpri~ing positioning at least 2 force focusing means radially exterior to the balloon prior to infl~tin~ the balloon.
RR~FF nF~CRTPTION OF T~F nR~ N~S
Figure 1 is a lo~itu~lin~l cross sectional illustration of an app~dllls of the present invention, shown in position at a stenosis in an artery.
Figure 2 is a transverse cross sectional illustration of an d~dlus of the present invention taken at 2-2 of Figure 1.
Figure 3 is a planar illustration of a spacer that can be used in the present invention for positioning the force focusing means.
l)li TATT,Fn ll~.~CRIPTION OF T~ ~NVh NTION
The present invention can be used with a wide variety of balloon catheters that have previously been developed for use with balloon angioplasty.
Such c~thetSer~ include, for example, those described in Danforth U. S. Patent 4,881,547, Buchbinder U. S. Patent 5,114,414, and Sahota U. S. Patent ~wo 95/02364 2 ~ ~ ~ 1; 6 4 PCT/US94/07711 5,143,093, each of which is hereby incorporated by reference. A wide variety of m~teri~le can be used for the balloons within such c~theter devices. One particularly advantageous m~teri~l is that described in Levy, U. S. Patent number Re. 33,561, also hereby incol~,oldled by reference.
S In accordance with the present invention, at least t~,vo longitu~lin~l force focusing means are positioned radially exterior to and co~ lly with the balloon c~tht-ter. The force focusing means focuses the radial ~le;,~ule of the balloon and, at the same time, distributes the force lon~ lin~lly. The force focusing means can be in the form of wires, and can be prepared from any subst~nti~lly non-toxic or medically non-reactive m~teri~le, generally the same metal and metal alloys used in the construction of angioplasty guide wires. In general, stainless steel and other ferrous alloys are particularly s~tief~ct~ry, and are accordingly preferred.
If the force focusing means are in the form of a wire, a subst~nti~lly round cross-sectional configuration is generally used. The ~ meterof the wires can vary el-bst~nti~lly, depending on the particular blood vessel in wllich the stenosis is found and the size of the rem~inin~ lumen within the blood vessel. However, for round wires, a ~ meter of about 0.25 - 0.50 mm is generally used. To f~cilit~tç insertion and positioning, the ends of the wires can be tapered.
In accordance with the present invention, at least two longitll~lin~l force focusing means are used. Typically, these will be uniformly spaced circumferentially around the balloon. However, in an ~ltern~tive embodiment of the invention, particularly if an asymmetric stenosis is being treated, a greater number of the force focuing means can be positioned ~rlj~cent to the thickest part of the stenosis. In ~ent r~l, little ~d~litiQn~l benefit is ~tt~inç(l with more than 4 force focusing means.
The force focusing means can be placed in position by separate insertion, as previously done for guide wires with balloon angioplasty techniques.
Guide wire e~eh~nge c~thetere can also be used to position the elements of the present a~paldlus. The force focusing means can also be simlllt~n~ously insertedthrough the blood vessel lumen. This can be done by embedding the distal ends of the force focusing means in a thimble. The thimble can be used in conjunctionwith collv~lllional catheter guidewires running through the center of the thimble.
WO 95/02364 ;~ PCT/US94/07711 In the ~lt~rn~tive~ the force focusing means can be inserted after insertion of the balloon itself.
The invention can be more fully understood by leÇ_~cnce to the drawings, in which Figure 1 is a lonpi~ in~l cross-sectional illllqtr~tion of an5 a~dLus of the present invention wherein longitu.lin~l force focusing means (1)are ~tt~ch~ at their distal ends, to a harness or thimble (2), having a central Lul~ 2A. The thimble can be made, for exarnple, of a soft themoplastic or el~qtoInt ric m~t~ri~l A balloon catheter (3) is positioned within the force focusing means, along a guide wire (4) running through the center of the balloon.
10 The balloon and the force focusing means are all positioned within the lurnendefined by stennqi~ (5) on the interior wall of artery (6). On inflation of the balloon, the force focusing means press into the wall of the stenosis, displacing or fr~r.tnring the plaque. Depending on the physical propcl lies of the plaque, it may be cracked, scored, or tliqpl~ecl to permit expansion of the lumen.
Figure 2 is a transverse cross-sectional illustration ofthe a~dlus of Figure 1, taken at section 2-2 of Figure 1.
The positioning of the force focusing means can be facilitated by a spacer as illllstr~tecl in Figure 3. The spacer, which can be inserted either simlllt~n~ously with or after the balloon itself, has a central a~ ule (11) for 20 positioning the balloon catheter and the guide wire, and pel;~.hF~,.l a~ Lul~s (12) for positioning the force focusing means. Thus, the central shaft of the c~theter and the guide wire are inserted into the central a~.lur~, having ret~ining tab (13) retain these components in place once inserted into the spacer. Similarly, the force focusing means are inserted through p~riph~r~l spacing ~lL~ILcs (12) so as25 to position these elements as desired around the balloon and in con~ er~tion of the configuration and positioning of the steno~i~. The positioning of the spacer is f~.ilit~te(l by a shaft or tether 14, ~tt~rhFd to the body of the spacer Positioning of the c~th~ter and the force focusing means can be done with the aid of collvellLional angiography equipment On the basis of the 30 information obtainable by such equipment, the cardiologist can select a wire pattern and positions such that the force focusing means are positioned at the point greatest lumen encro~r.hment Thus, based on the information available, the force focusing means can be spaced evenly around the lumen or adjusted in a ~wo 95,02364 2 ~ ~ 7 1 6 ~ PCTtUS94/07711 pattern such that they are concentrated on the side of the balloon in which the heaviest deposit of plaque is found.
The snrf~cee of a force focusing means should be :jub~ 11y free from sharp edges. This ~ ";~s potential damage to arterial walls and, by 5 either distributing the plaque or rlnCLII. ;.l~ the plaque by deformation"";~.;...;~e restenosis after the angioplasty.
The ideal application of the a~dLus of the present invention is dependent on individual vessel and stenosis char~cterietics. Depending on vesselsize and stenosis or lesion severity, one or more wires will be positioned across 10 the stenosis using a positioning meçh~niem The positioning of the balloon, ifdesired, can be done .eimlllt~neously with the positioning of the force focusingmeans. Once the desired initial arrangement of components is made, an initial balloon inflation will be p~lrulllled. The present invention can permit relatively low pLC;~ ;S and a relatively small number of inflations to produce significant 15 increases in luminal cross section area. Depending on the response to the initial arrangement of the a~udLu~ colll~onents, further inflations with a larger balloon may be desirable, or a change in the nurnber or positioning of the force distributing means, or all of the above. The present invention causes plaque deformation to occur l,lcferelllially in lon~itl~-lin~l lines, co~ lly with the vessel 20 lumen, and allows the resilient portions of the artery to stretch after the plaque we~kP.ning has been created with the force distributing means.
While the advantages of the present invention are not fully ntler.etood, it is believed that the longi~ in~l force focusing means, by sirnultaneously focusing the radial force of the balloon and distributing it in a 25 longitudinal direction, permit fracture or redistribution of the stenosis with minim~l damage to the artery wall. With a stenosis or ~ccllmlll~ted plaque that does not fracture during tre~tment the lc ngit~flin~l distribution of the balloon force can limit the restenosis process, in that any restenosis oCcllrring after the angioplasty may be concentr~te~l in the groves formed by the longitl~.lin~l force 30 focusing means during inflation of the balloon. The instant invention thus provides a means for limiting the damage caused by balloon inflation to the eh~nnele of the artery coaxial to the artery lumen, and coneentr~tes restenosis to smaller se~mente of the arterial wall.
WO 95/02364 ~ t ~ ~ ~ 6 4 PCT/US94/07711 The present invention is further illustrated by the following specific example.
FX~.~PT F t S After selecting a cO~ ~ y artery stenosis ~pr~liate for balloon dilatation, an angioplasty guide ç~th~ter is selected and used to intllb~te the proximal vessel. The stçnosi~ is crossed with a 0.014 inch High Torque Floppy (ACS) guide wire of coated st~inless steel. Three force focusing means in the form of 0.014 inch Standard guide wires (USCI) are delivered across the stenosis10 over the previously placed 0.014 inch High Torque Floppy guide wire. A
standard angioplasty balloon is advanced to the lesion over the initially placedguide wire. A balloon size is selected to be 0.5 to 0.75 mm less than the pLe~ulll~liv~ normal vessel diameter at the stenosis site. After balloon positioning, a series of inflations is performed with plC;7~ S kept in the range of 15 two to six ~tmosph~res. When post inflation angiography suggests suitable lumen caliber has been achieved, the focusing wires are withdrawn and another angiographic vi~ li7~tion of the stenotic area is made with the original guide wire still in place. If results are acceptable, this wire is then removed. Otherwise dirr~lc;llL balloon size and/or inflation ~LI~te~,y is used depending on the vascular 20 anatomy present.
Over a six month period, the restenosis is observed to be lower than typical for conventional balloon angioplasty trç~tment without the longit l-lin~l wires.
RACKGI~OUND OF INYh l~TION
Arteriosclerosis has long been a serious cardiovascular problem, 5 involving the ~ccllm~ tion of deposits or plaque on the interior walls of blood vessels, prim~rily arteries. ~ccllm~ tinn of such plaque can result in areas of the blood vessel in which a significant portion of the flow is blocked. Such significant blockage is char~stPri7Pcl as a stPnor,i~, which causes reduced flowthrough the blood vessel.
In the past, serious stenoses could generally be alleviated only by bypassing of the blood vessel. More recently, angioplasty techniques were developed to open stenoses in arteries. In such techniques, a balloon ç~thPtPr is typically inserted in the blood vessel, and the balloon is positioned at the site of the stenosis. Upon inflation, the balloon presses radially on deposited plaque at the site and on the blood vessel wall behind the plaque. Plaque deposits are often irregular in transverse cross-section. Thick portions inl~,rel~ with the ullir~
expansion of the balloon, and are, in their composition, non-uniform. These considerations increase the possibility of damage to the artery walls. It has previously been suggested to use a guide wire outside of and parallel to a catheter balloon to produce a crack in heavily calcified plaque, giving improved results and larger openings with less pl`eS~iUIe and damage. Such techniques were previously used when normal balloon p,e~ ,u~e did not s~ti~f~rtorily dilate the vessel.
Still other techniques for improving angioplasty tre~tment include the suggestion of lon~it~ in~l cutting strips f~etel~ecl on the balloon wall.
Fxp~n~ion of the balloon forces these edges ou~w~d radially to cut into the plaque. Such cutting edges seriously reduce the flexibility of the balloon, and increase the crossing profile. These r~lu,es impose limit~tions on the ability to position the device in tortuous vessels.
Still other in,l.,we",ents in angioplasty techniques involved the balloon itself, providing balloons with improved burst pressure and strength char~qctPri~tics balanced such that a balloon, if failure occurred, would burst in the lon~ in~l or axial direction as opposed to the transverse direction, facilit~tin~
removal under such circllm~t~nr,çs.
WO 95/02364 2 1, 6~1 ~s ~ ~ PCTtUS94/07711--A con~ need exists for angioplasty d~aldlus and techniques that balance the effective opening of the stenosis, minim~l damage to the wall of the blood vessel, and ~in;~ ;on of the reformation of the stenosis after completion of the angioplasty.
SUMMARY OF INYli NTION
The present invention provides an improvement in angioplasty techniques using balloon G~th~tPr~ which improves the efficiency and safety of the procedure and, in addition, tends to inhibit restenosis or subsequent build up ofplaque.
Specifically, the instant invention provides, in an angioplasty a~p~dlus comprising a balloon catheter for applying radial pressure to an arterial stenosis, the improvement wherein the appdldllls further comprises at least 2 lon~itll-lin~l force distributing means positioned radially exterior to the balloon.
The invention further provides an improved process for balloon angioplasty in which a balloon ç~th~ter is inserted into an artery, the balloon positioned at the site of a stenosis, and the balloon Iqxp~n~le(l to increase the size of the channel through the stenosis, the improvement cornpri~ing positioning at least 2 force focusing means radially exterior to the balloon prior to infl~tin~ the balloon.
RR~FF nF~CRTPTION OF T~F nR~ N~S
Figure 1 is a lo~itu~lin~l cross sectional illustration of an app~dllls of the present invention, shown in position at a stenosis in an artery.
Figure 2 is a transverse cross sectional illustration of an d~dlus of the present invention taken at 2-2 of Figure 1.
Figure 3 is a planar illustration of a spacer that can be used in the present invention for positioning the force focusing means.
l)li TATT,Fn ll~.~CRIPTION OF T~ ~NVh NTION
The present invention can be used with a wide variety of balloon catheters that have previously been developed for use with balloon angioplasty.
Such c~thetSer~ include, for example, those described in Danforth U. S. Patent 4,881,547, Buchbinder U. S. Patent 5,114,414, and Sahota U. S. Patent ~wo 95/02364 2 ~ ~ ~ 1; 6 4 PCT/US94/07711 5,143,093, each of which is hereby incorporated by reference. A wide variety of m~teri~le can be used for the balloons within such c~theter devices. One particularly advantageous m~teri~l is that described in Levy, U. S. Patent number Re. 33,561, also hereby incol~,oldled by reference.
S In accordance with the present invention, at least t~,vo longitu~lin~l force focusing means are positioned radially exterior to and co~ lly with the balloon c~tht-ter. The force focusing means focuses the radial ~le;,~ule of the balloon and, at the same time, distributes the force lon~ lin~lly. The force focusing means can be in the form of wires, and can be prepared from any subst~nti~lly non-toxic or medically non-reactive m~teri~le, generally the same metal and metal alloys used in the construction of angioplasty guide wires. In general, stainless steel and other ferrous alloys are particularly s~tief~ct~ry, and are accordingly preferred.
If the force focusing means are in the form of a wire, a subst~nti~lly round cross-sectional configuration is generally used. The ~ meterof the wires can vary el-bst~nti~lly, depending on the particular blood vessel in wllich the stenosis is found and the size of the rem~inin~ lumen within the blood vessel. However, for round wires, a ~ meter of about 0.25 - 0.50 mm is generally used. To f~cilit~tç insertion and positioning, the ends of the wires can be tapered.
In accordance with the present invention, at least two longitll~lin~l force focusing means are used. Typically, these will be uniformly spaced circumferentially around the balloon. However, in an ~ltern~tive embodiment of the invention, particularly if an asymmetric stenosis is being treated, a greater number of the force focuing means can be positioned ~rlj~cent to the thickest part of the stenosis. In ~ent r~l, little ~d~litiQn~l benefit is ~tt~inç(l with more than 4 force focusing means.
The force focusing means can be placed in position by separate insertion, as previously done for guide wires with balloon angioplasty techniques.
Guide wire e~eh~nge c~thetere can also be used to position the elements of the present a~paldlus. The force focusing means can also be simlllt~n~ously insertedthrough the blood vessel lumen. This can be done by embedding the distal ends of the force focusing means in a thimble. The thimble can be used in conjunctionwith collv~lllional catheter guidewires running through the center of the thimble.
WO 95/02364 ;~ PCT/US94/07711 In the ~lt~rn~tive~ the force focusing means can be inserted after insertion of the balloon itself.
The invention can be more fully understood by leÇ_~cnce to the drawings, in which Figure 1 is a lonpi~ in~l cross-sectional illllqtr~tion of an5 a~dLus of the present invention wherein longitu.lin~l force focusing means (1)are ~tt~ch~ at their distal ends, to a harness or thimble (2), having a central Lul~ 2A. The thimble can be made, for exarnple, of a soft themoplastic or el~qtoInt ric m~t~ri~l A balloon catheter (3) is positioned within the force focusing means, along a guide wire (4) running through the center of the balloon.
10 The balloon and the force focusing means are all positioned within the lurnendefined by stennqi~ (5) on the interior wall of artery (6). On inflation of the balloon, the force focusing means press into the wall of the stenosis, displacing or fr~r.tnring the plaque. Depending on the physical propcl lies of the plaque, it may be cracked, scored, or tliqpl~ecl to permit expansion of the lumen.
Figure 2 is a transverse cross-sectional illustration ofthe a~dlus of Figure 1, taken at section 2-2 of Figure 1.
The positioning of the force focusing means can be facilitated by a spacer as illllstr~tecl in Figure 3. The spacer, which can be inserted either simlllt~n~ously with or after the balloon itself, has a central a~ ule (11) for 20 positioning the balloon catheter and the guide wire, and pel;~.hF~,.l a~ Lul~s (12) for positioning the force focusing means. Thus, the central shaft of the c~theter and the guide wire are inserted into the central a~.lur~, having ret~ining tab (13) retain these components in place once inserted into the spacer. Similarly, the force focusing means are inserted through p~riph~r~l spacing ~lL~ILcs (12) so as25 to position these elements as desired around the balloon and in con~ er~tion of the configuration and positioning of the steno~i~. The positioning of the spacer is f~.ilit~te(l by a shaft or tether 14, ~tt~rhFd to the body of the spacer Positioning of the c~th~ter and the force focusing means can be done with the aid of collvellLional angiography equipment On the basis of the 30 information obtainable by such equipment, the cardiologist can select a wire pattern and positions such that the force focusing means are positioned at the point greatest lumen encro~r.hment Thus, based on the information available, the force focusing means can be spaced evenly around the lumen or adjusted in a ~wo 95,02364 2 ~ ~ 7 1 6 ~ PCTtUS94/07711 pattern such that they are concentrated on the side of the balloon in which the heaviest deposit of plaque is found.
The snrf~cee of a force focusing means should be :jub~ 11y free from sharp edges. This ~ ";~s potential damage to arterial walls and, by 5 either distributing the plaque or rlnCLII. ;.l~ the plaque by deformation"";~.;...;~e restenosis after the angioplasty.
The ideal application of the a~dLus of the present invention is dependent on individual vessel and stenosis char~cterietics. Depending on vesselsize and stenosis or lesion severity, one or more wires will be positioned across 10 the stenosis using a positioning meçh~niem The positioning of the balloon, ifdesired, can be done .eimlllt~neously with the positioning of the force focusingmeans. Once the desired initial arrangement of components is made, an initial balloon inflation will be p~lrulllled. The present invention can permit relatively low pLC;~ ;S and a relatively small number of inflations to produce significant 15 increases in luminal cross section area. Depending on the response to the initial arrangement of the a~udLu~ colll~onents, further inflations with a larger balloon may be desirable, or a change in the nurnber or positioning of the force distributing means, or all of the above. The present invention causes plaque deformation to occur l,lcferelllially in lon~itl~-lin~l lines, co~ lly with the vessel 20 lumen, and allows the resilient portions of the artery to stretch after the plaque we~kP.ning has been created with the force distributing means.
While the advantages of the present invention are not fully ntler.etood, it is believed that the longi~ in~l force focusing means, by sirnultaneously focusing the radial force of the balloon and distributing it in a 25 longitudinal direction, permit fracture or redistribution of the stenosis with minim~l damage to the artery wall. With a stenosis or ~ccllmlll~ted plaque that does not fracture during tre~tment the lc ngit~flin~l distribution of the balloon force can limit the restenosis process, in that any restenosis oCcllrring after the angioplasty may be concentr~te~l in the groves formed by the longitl~.lin~l force 30 focusing means during inflation of the balloon. The instant invention thus provides a means for limiting the damage caused by balloon inflation to the eh~nnele of the artery coaxial to the artery lumen, and coneentr~tes restenosis to smaller se~mente of the arterial wall.
WO 95/02364 ~ t ~ ~ ~ 6 4 PCT/US94/07711 The present invention is further illustrated by the following specific example.
FX~.~PT F t S After selecting a cO~ ~ y artery stenosis ~pr~liate for balloon dilatation, an angioplasty guide ç~th~ter is selected and used to intllb~te the proximal vessel. The stçnosi~ is crossed with a 0.014 inch High Torque Floppy (ACS) guide wire of coated st~inless steel. Three force focusing means in the form of 0.014 inch Standard guide wires (USCI) are delivered across the stenosis10 over the previously placed 0.014 inch High Torque Floppy guide wire. A
standard angioplasty balloon is advanced to the lesion over the initially placedguide wire. A balloon size is selected to be 0.5 to 0.75 mm less than the pLe~ulll~liv~ normal vessel diameter at the stenosis site. After balloon positioning, a series of inflations is performed with plC;7~ S kept in the range of 15 two to six ~tmosph~res. When post inflation angiography suggests suitable lumen caliber has been achieved, the focusing wires are withdrawn and another angiographic vi~ li7~tion of the stenotic area is made with the original guide wire still in place. If results are acceptable, this wire is then removed. Otherwise dirr~lc;llL balloon size and/or inflation ~LI~te~,y is used depending on the vascular 20 anatomy present.
Over a six month period, the restenosis is observed to be lower than typical for conventional balloon angioplasty trç~tment without the longit l-lin~l wires.
Claims (9)
1. In an angioplasty apparatus comprising a balloon catheter for applying radial pressure to a vascular stenosis, and extending at least from a point of insertion to the stenosis, the improvement wherein the apparatus further comprises at least two longitudinal force focusing wires having a substantially circular cross section, each wire having a proximal and a distal end, the proximal end of each wire extending proximal to the balloon catheter and the wires positioned radially exterior to the balloon.
2. An apparatus of Claim 1 wherein the distal ends of the force focusing wires are joined to a harness.
3. An apparatus of Claim 1 comprising from two to four longitudinal force focusing wires.
4. An apparatus of Claim 3 comprising three force focusing means wires.
5. An apparatus of Claim 2 wherein the diameter of the wires is about from 0.25 to 0.50 mm.
6. An apparatus of Claim 1 wherein the force focusing wires are equally spaced around the circumference of the balloon.
7. An apparatus of Claim 1 wherein the force focusing wires are asymmetrically spaced around the circumference of the balloon.
8. In an angioplasty apparatus comprising a balloon catheter for applying radial pressure to a vascular stenosis, and extending at least from a point of insertion to the stenosis, the improvement wherein the apparatus further comprises at least two longitudinal force focusing wires having a substantially circular cross section, each wire having a proximal and a distal end, the proximal end of each wire extending proximal to the balloon catheter and the wires positioned radially exterior to the balloon and further comprising a substantially circular spacer having a central aperture adapted to receive a balloon catheter shaft and an angioplasty guide wire and circumferential apparatus adapted to receive the longitudinal force focusing wires.
9. In a process for balloon angioplasty in which a balloon catheter is inserted into an artery, the balloon positioned at the site of a stenosis, and the balloon expanded to increase the size of the channel through the stenosis, the improvement comprising positioning, radially exterior to the balloon prior to inflating the balloon, at least two longitudinal force focusing wires having a substantially circular cross-section, each wire having a proximal and a distal end, the proximal end of each wire extending proximal to the balloon catheter.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/089,187 | 1993-07-12 | ||
| US08/089,187 US5411478A (en) | 1993-07-12 | 1993-07-12 | Angioplasty apparatus and process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2167164A1 true CA2167164A1 (en) | 1995-01-26 |
Family
ID=22216204
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002167164A Abandoned CA2167164A1 (en) | 1993-07-12 | 1994-07-11 | Improved angioplasty apparatus and process |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US5411478A (en) |
| JP (1) | JPH10503939A (en) |
| CA (1) | CA2167164A1 (en) |
| WO (1) | WO1995002364A1 (en) |
Families Citing this family (46)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US5665103A (en) * | 1996-03-07 | 1997-09-09 | Scimed Life Systems, Inc. | Stent locating device |
| US6007517A (en) * | 1996-08-19 | 1999-12-28 | Anderson; R. David | Rapid exchange/perfusion angioplasty catheter |
| US6309339B1 (en) * | 1997-03-28 | 2001-10-30 | Endosonics Corporation | Intravascular radiation delivery device |
| US6572630B1 (en) * | 2000-01-31 | 2003-06-03 | Rex Medical, L.P | Atherectomy device |
| US7632288B2 (en) | 2003-05-12 | 2009-12-15 | Boston Scientific Scimed, Inc. | Cutting balloon catheter with improved pushability |
| US7758604B2 (en) * | 2003-05-29 | 2010-07-20 | Boston Scientific Scimed, Inc. | Cutting balloon catheter with improved balloon configuration |
| US7754047B2 (en) | 2004-04-08 | 2010-07-13 | Boston Scientific Scimed, Inc. | Cutting balloon catheter and method for blade mounting |
| US7566319B2 (en) | 2004-04-21 | 2009-07-28 | Boston Scientific Scimed, Inc. | Traction balloon |
| US9125667B2 (en) * | 2004-09-10 | 2015-09-08 | Vessix Vascular, Inc. | System for inducing desirable temperature effects on body tissue |
| US7291158B2 (en) * | 2004-11-12 | 2007-11-06 | Boston Scientific Scimed, Inc. | Cutting balloon catheter having a segmented blade |
| US8038691B2 (en) | 2004-11-12 | 2011-10-18 | Boston Scientific Scimed, Inc. | Cutting balloon catheter having flexible atherotomes |
| AU2005323017B2 (en) * | 2004-12-30 | 2010-12-02 | Cook Medical Technologies Llc | Catheter assembly with plaque cutting balloon |
| US20060178685A1 (en) * | 2004-12-30 | 2006-08-10 | Cook Incorporated | Balloon expandable plaque cutting device |
| WO2006074256A1 (en) * | 2005-01-05 | 2006-07-13 | Cook Incorporated | Angioplasty cutting device and apparatus for treating a stenotic lesion in a body vessel |
| US20060184191A1 (en) | 2005-02-11 | 2006-08-17 | Boston Scientific Scimed, Inc. | Cutting balloon catheter having increased flexibility regions |
| US7708753B2 (en) | 2005-09-27 | 2010-05-04 | Cook Incorporated | Balloon catheter with extendable dilation wire |
| US8123770B2 (en) * | 2005-11-01 | 2012-02-28 | Cook Medical Technologies Llc | Angioplasty cutting device and method for treating a stenotic lesion in a body vessel |
| US20080228139A1 (en) * | 2007-02-06 | 2008-09-18 | Cook Incorporated | Angioplasty Balloon With Concealed Wires |
| US8323307B2 (en) * | 2007-02-13 | 2012-12-04 | Cook Medical Technologies Llc | Balloon catheter with dilating elements |
| US20080300610A1 (en) | 2007-05-31 | 2008-12-04 | Cook Incorporated | Device for treating hardened lesions and method of use thereof |
| US20090171284A1 (en) * | 2007-12-27 | 2009-07-02 | Cook Incorporated | Dilation system |
| US20090171283A1 (en) * | 2007-12-27 | 2009-07-02 | Cook Incorporated | Method of bonding a dilation element to a surface of an angioplasty balloon |
| EP2636422B1 (en) | 2008-03-13 | 2018-10-31 | Cook Medical Technologies LLC | Cutting balloon with connector and dilation element |
| US9480826B2 (en) | 2008-03-21 | 2016-11-01 | Cagent Vascular, Llc | Intravascular device |
| WO2009117158A2 (en) * | 2008-03-21 | 2009-09-24 | Innovasc Llc | Device and method for opening blood vessels by pre-angioplasty serration and dilatation of aetherosclerotic plaque |
| US11229777B2 (en) | 2008-03-21 | 2022-01-25 | Cagent Vascular, Inc. | System and method for plaque serration |
| US20100010521A1 (en) * | 2008-07-10 | 2010-01-14 | Cook Incorporated | Cutting balloon with movable member |
| US9539081B2 (en) | 2009-12-02 | 2017-01-10 | Surefire Medical, Inc. | Method of operating a microvalve protection device |
| US8348987B2 (en) * | 2009-12-22 | 2013-01-08 | Cook Medical Technologies Llc | Balloon with scoring member |
| US8585959B2 (en) | 2010-09-30 | 2013-11-19 | Cook Medical Technologies Llc | Balloon with integrally retained dilation element |
| US9808276B2 (en) * | 2013-04-25 | 2017-11-07 | Invatec S.P.A. | Angioplasty balloon having selectively deployable cutting or scoring element and related methods |
| US10286190B2 (en) | 2013-12-11 | 2019-05-14 | Cook Medical Technologies Llc | Balloon catheter with dynamic vessel engaging member |
| EP2898920B1 (en) | 2014-01-24 | 2018-06-06 | Cook Medical Technologies LLC | Articulating balloon catheter |
| US9968740B2 (en) | 2014-03-25 | 2018-05-15 | Surefire Medical, Inc. | Closed tip dynamic microvalve protection device |
| WO2015187872A1 (en) | 2014-06-04 | 2015-12-10 | Cagent Vascular, Llc | Cage for medical balloon |
| US10471238B2 (en) | 2014-11-03 | 2019-11-12 | Cagent Vascular, Llc | Serration balloon |
| US20160287839A1 (en) | 2015-03-31 | 2016-10-06 | Surefire Medical, Inc. | Apparatus and Method for Infusing an Immunotherapy Agent to a Solid Tumor for Treatment |
| CN113907834A (en) | 2015-09-17 | 2022-01-11 | 开金血管公司 | Wedge-shaped cutter of medical air bag |
| US10780250B1 (en) | 2016-09-19 | 2020-09-22 | Surefire Medical, Inc. | System and method for selective pressure-controlled therapeutic delivery |
| US11400263B1 (en) | 2016-09-19 | 2022-08-02 | Trisalus Life Sciences, Inc. | System and method for selective pressure-controlled therapeutic delivery |
| US10905863B2 (en) | 2016-11-16 | 2021-02-02 | Cagent Vascular, Llc | Systems and methods of depositing drug into tissue through serrations |
| US10588636B2 (en) | 2017-03-20 | 2020-03-17 | Surefire Medical, Inc. | Dynamic reconfigurable microvalve protection device |
| CN112739406A (en) | 2018-07-25 | 2021-04-30 | 开金血管有限公司 | Medical balloon catheter with enhanced pushability |
| US11850398B2 (en) | 2018-08-01 | 2023-12-26 | Trisalus Life Sciences, Inc. | Systems and methods for pressure-facilitated therapeutic agent delivery |
| US11338117B2 (en) | 2018-10-08 | 2022-05-24 | Trisalus Life Sciences, Inc. | Implantable dual pathway therapeutic agent delivery port |
| US11911581B1 (en) | 2022-11-04 | 2024-02-27 | Controlled Delivery Systems, Inc. | Catheters and related methods for the aspiration controlled delivery of closure agents |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4484579A (en) * | 1982-07-19 | 1984-11-27 | University Of Pittsburgh | Commissurotomy catheter apparatus and method |
| USRE33561E (en) * | 1983-07-05 | 1991-03-26 | E. I. Du Pont De Nemours And Company | Balloon and manufacture thereof |
| US4793348A (en) * | 1986-11-15 | 1988-12-27 | Palmaz Julio C | Balloon expandable vena cava filter to prevent migration of lower extremity venous clots into the pulmonary circulation |
| US4893623A (en) * | 1986-12-09 | 1990-01-16 | Advanced Surgical Intervention, Inc. | Method and apparatus for treating hypertrophy of the prostate gland |
| US4921484A (en) * | 1988-07-25 | 1990-05-01 | Cordis Corporation | Mesh balloon catheter device |
| CA2026604A1 (en) * | 1989-10-02 | 1991-04-03 | Rodney G. Wolff | Articulated stent |
| US5221261A (en) * | 1990-04-12 | 1993-06-22 | Schneider (Usa) Inc. | Radially expandable fixation member |
| US5196024A (en) * | 1990-07-03 | 1993-03-23 | Cedars-Sinai Medical Center | Balloon catheter with cutting edge |
| US5143093A (en) * | 1990-10-05 | 1992-09-01 | Harvinder Sahota | Methods of angioplasty treatment of stenotic regions |
| US5269802A (en) * | 1991-09-10 | 1993-12-14 | Garber Bruce B | Prostatic stent |
-
1993
- 1993-07-12 US US08/089,187 patent/US5411478A/en not_active Expired - Fee Related
-
1994
- 1994-07-11 WO PCT/US1994/007711 patent/WO1995002364A1/en active Application Filing
- 1994-07-11 JP JP7504636A patent/JPH10503939A/en active Pending
- 1994-07-11 CA CA002167164A patent/CA2167164A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| JPH10503939A (en) | 1998-04-14 |
| WO1995002364A1 (en) | 1995-01-26 |
| US5411478A (en) | 1995-05-02 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |