CA2109095A1 - Helical balloon perfusion angioplasty catheter - Google Patents
Helical balloon perfusion angioplasty catheterInfo
- Publication number
- CA2109095A1 CA2109095A1 CA002109095A CA2109095A CA2109095A1 CA 2109095 A1 CA2109095 A1 CA 2109095A1 CA 002109095 A CA002109095 A CA 002109095A CA 2109095 A CA2109095 A CA 2109095A CA 2109095 A1 CA2109095 A1 CA 2109095A1
- Authority
- CA
- Canada
- Prior art keywords
- balloon
- catheter
- balloon catheter
- shaft
- straps
- 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
- 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
- A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
-
- 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
- A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
-
- 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
- A61M25/1002—Balloon catheters characterised by balloon shape
Abstract
2109095 9218195 PCTABS00016 A perfusion balloon catheter which permits blood flow through the balloon even when the balloon is inflated. The balloon catheter comprises a thin-walled, collapsible and inflatable tube (32) that has a proximal, generally straight portion, and a distal, helically coiled portion that is generally cylindrically shaped and defines an open lumen (34) therethrough. The successive turns of the coil are secured to one another (45) to maintain the balloon's configuration when inflated. The furled balloon catheter can be inserted to the desired location and then inflated. Because the helically coiled portion defines a relatively large open lumen (34), blood flow through the balloon can continue even as the inflated balloon remains in place, facilitating extended inflation periods.
Description
WO 92/18195 PCI~/US92/03~83 , ~i~
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HELICAI. BALLOON PERF~JSION ANGIOPLASTY CATHETER
FIELD OF THE INV~TION
The invention relates to balloon catheters of the type used in balloon angioplasty and similar medical procedures.
BACKGROUND OF THE INV~TION
over the last several years great advances have been made in the feasibility and success of balloon angioplasty, both in peripheral arteries and coronary ;-arteries. Percutaneous transluminal coronary angioplasty (PTCA) has now become an established technique for treatment of atherosclerotic obstructions in coronary arteries. For many patients, this procedure eliminates the need to undergo coronary bypass surgery.
~ ecent studies have suggested that the effectiveness o balloon angioplasty (including PTCA) increases if the in1ation of the balloon can be more gradual and~if the duration of balloon inflation can be lengthened. Since conventional balloons entirely occiude the artery when inflated (including any side branches in the artery adjacent the balloon), the duration of balioon inflatio~ often is limited by patient tolerance of chest pain and hemodynamic or electrical instability, as well as eventual tissue necrosis distally of the balloon if the circulation is cut off too long.
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' WO92/181gS~ PCT/US92/03~3 - 21090~ t~
A variety of techniques have been proposed to mitigate these limitations, including various drug treatments (e.g., pretreatment with lidocaine, nitroglycerin, etc.), retroperfusion via the coronary sinus, and even the use of general anesthesia. One tehcnique that mitigates many of these limitations is the use of a perfusion balloon catheter, such as that developed by Stack (see, e.g., D. Kereiakes & R.
Stack, "Perfusion Angioplasty," Textbook of Interventional CardioloqY (E. Topol, ed., l990)). In these types of balloon catheters, the catheter shaft incudes side holes both proximally and distally of the balloon. These holes allow blood to enter the catheter lumen proximally of the balloon and then pass through the lumen into the artery distally of the balloon, thus preserving some blood flow even when the balloon is inflated. The shaft of such perfusion baIloon catheters, however, is necessarily relatively large (in order to permit a significant amount of blood flow therethrough), and the catheter consequently is less flexible, limiting its use and effectiveness. Moreover, side branches.of the artery may still be occluded by the balloon if the stenotic segment~is near or spans such a branch.
SUMMARY OF THE INVENTION
.
The invention provides a-perfusion balloon ~ cath~ér that avoids many of the drawbacks of the `~ -~`Stack-type balloon catheter~. The balloon catheter of ~ the invention comprises-a thin walled collapsable and - inf}atable tubè that has a proximal, generally ~- - straight portion, and `a distal, helically coiled portion that` is generally cylindrically shaped and defines an open lumen therethrough. Means is provided for securing the turns of the coil with respect to one another, such as ~y providing an outer or inner skin ,:~
' :
W092/18~gS-i~ PCT/US92/03 ~ .
to which the turns adhere.
In use, the furled balloon catheter i8 inserted to the desired location and then inflated. Because the helically coiled portion defines a relatively large open lumen, blood flow through the balloon can continue even as the inflated balloon remains in place. This allows an extended period of inflation without the side effects attendant with conventional balloons (such as chest pain, etc.). Moreover, the diameter of the central lumen can allow for blood flow equivalent to or greater than the Stack-type balloon, without the size and rigidity problems experienced by those balloons.
Although the turns of the coiled balloon preferably abut one another, in certain embodiments one or`more spa~es in the helical coil wall can be provided (by spacing successive`turns from one another) to facilitate blood flow through arterial side branches that otherwi~e would ~e occluded by conventional balloons (including Stack-type balloons). The helical balloon can also be easily configur~d to have a predetermined bend (or flexibility to bend) for procedures at or very near sharp arteriil bends, such as by pre-configuring the balloon with a bend or by providing spaces in the hèlical coil to give it greater flexibility at certain points. `` ` ~ -BRIEF~DESCRIPTION OF THE DRAWINGS
Figure 1 shows a helical balloon catheter of theinvention; ~ -Figure 2 shows the balloon catheter of Figure 1advanced into an artherosclerotic artery and partially inflated;
Figure 3 shows the balloon catheter of Figure 2 fully inflated with a perfusion or contrast injection :, '` .
~ . wos2/l8l~ PCTrUS92/03~ ~
catheter advanced over the guide wire;
Figure 4 shows the balloon catheter of the invention in its furled configuration being advanced into an artherosclerotic artery, with a pushing catheter advanced over the guide wire;
Figure 5 shows the balloon catheter of Figure 1 in a slightly different configuration;
Figure 6 shows yet another configuration of the balloon catheter:
Figure 7 shows yet a further embodiment bf the balloon catheter;
Figure 8 shows yet a further embodiment of the balloon catheter;
Figure 9 shows yet another embodiment of the balloon catheter where the tube is folded back upon itself and wound in a double helix fashion;
Figure 10 shows yet another helical balloon catheter having three helically wound tubes;
Figure 11 shows yet another embodiment of the balloon catheter~
Figure 12 shows another embodiment having a space between successive turns of the balloon to permit circulation through a side branch artery;
Figure 13 shows another embodiment having a space between successive turns of the balloon to give the balloon~greater flexibility at a midpoint for use at a~ harp~bend in an artery;
Figure 14~shows another:embodiment having a ~ . .. , . ~ . . . ...... . .
pre-determined.curve;
Figure lS shows a tube that can be wound into the oonfiguration shown in Figure 14,-with ~igures 15A-lSC showing selective cross-sections through lines , t lSA-lSA, lSB-lSB, and lSC-lSC, respectively;
Figure 16 shows a helical balloon catheter having an outer sheath; and ,~
.~ '' WO 92/18195 ' PCI~/USg2/032&3 _ 5 210~og5 Figure 17 shows a slightly different embodiment ~ of the helical catheter used as an introducer catheter.
t BEST MODE FOR QRRYING OUT THE INV~ION
- Figure 1 depicts generally a helical balloo~
catheter of the invention. The balloon catheter of the invention preferably is comprised of a small thin walled, collapsable tube 32 wound into a helical coil to form a generally cylindrical inflatable balloon i portion that has a large open lumen 34 therethrough.
The lumen 34 therefore presents a substantially open passageway both distally and proximally, allowing blood to continue flowing through the balloon even when it is inflated.
Successive turns of the helical tube 32 abut one ' another and are held in position either by adhesive or similar means and/or the intermediate portions 45 of the longitudinal straps 94. In this particular embodiment the straps 94 are attached to a central guide wire 39 at their distal ends 44, and are also ~` attached to the guide wire 39 proximally of the heliaal portion of the balloon. The proximal portion 36 of the tube 32 itself may also be attached to the guide wire 39. so that the stresses of advancement and withdrawal of the balloon are born by the guide wire ~ 39 and the ætraps 94, not the tube 32. Such distal !j~ and proximal fixation of the straps 94 to the guide wire 39 also longitudinally secures the location of the helical balloon`with`~rèspect to the guide wire 39. An inflation device 80 is connected to the proximal portion 36 of the tube 32 for inflating and deflating the helical balloon.
Figure 2 depicts the balloon of Figure 1 in its partially inflated configuration, ha~ing been advanced into an artery 95-to a narrowed atherosclerotic portion 96 of the artery 95. In Figure 3, the balloon ,t ~ t'`' i ~ W092/18195 PCT/US92/03~
.
~'' .
HELICAI. BALLOON PERF~JSION ANGIOPLASTY CATHETER
FIELD OF THE INV~TION
The invention relates to balloon catheters of the type used in balloon angioplasty and similar medical procedures.
BACKGROUND OF THE INV~TION
over the last several years great advances have been made in the feasibility and success of balloon angioplasty, both in peripheral arteries and coronary ;-arteries. Percutaneous transluminal coronary angioplasty (PTCA) has now become an established technique for treatment of atherosclerotic obstructions in coronary arteries. For many patients, this procedure eliminates the need to undergo coronary bypass surgery.
~ ecent studies have suggested that the effectiveness o balloon angioplasty (including PTCA) increases if the in1ation of the balloon can be more gradual and~if the duration of balloon inflation can be lengthened. Since conventional balloons entirely occiude the artery when inflated (including any side branches in the artery adjacent the balloon), the duration of balioon inflatio~ often is limited by patient tolerance of chest pain and hemodynamic or electrical instability, as well as eventual tissue necrosis distally of the balloon if the circulation is cut off too long.
,~
'~
~ ::
' WO92/181gS~ PCT/US92/03~3 - 21090~ t~
A variety of techniques have been proposed to mitigate these limitations, including various drug treatments (e.g., pretreatment with lidocaine, nitroglycerin, etc.), retroperfusion via the coronary sinus, and even the use of general anesthesia. One tehcnique that mitigates many of these limitations is the use of a perfusion balloon catheter, such as that developed by Stack (see, e.g., D. Kereiakes & R.
Stack, "Perfusion Angioplasty," Textbook of Interventional CardioloqY (E. Topol, ed., l990)). In these types of balloon catheters, the catheter shaft incudes side holes both proximally and distally of the balloon. These holes allow blood to enter the catheter lumen proximally of the balloon and then pass through the lumen into the artery distally of the balloon, thus preserving some blood flow even when the balloon is inflated. The shaft of such perfusion baIloon catheters, however, is necessarily relatively large (in order to permit a significant amount of blood flow therethrough), and the catheter consequently is less flexible, limiting its use and effectiveness. Moreover, side branches.of the artery may still be occluded by the balloon if the stenotic segment~is near or spans such a branch.
SUMMARY OF THE INVENTION
.
The invention provides a-perfusion balloon ~ cath~ér that avoids many of the drawbacks of the `~ -~`Stack-type balloon catheter~. The balloon catheter of ~ the invention comprises-a thin walled collapsable and - inf}atable tubè that has a proximal, generally ~- - straight portion, and `a distal, helically coiled portion that` is generally cylindrically shaped and defines an open lumen therethrough. Means is provided for securing the turns of the coil with respect to one another, such as ~y providing an outer or inner skin ,:~
' :
W092/18~gS-i~ PCT/US92/03 ~ .
to which the turns adhere.
In use, the furled balloon catheter i8 inserted to the desired location and then inflated. Because the helically coiled portion defines a relatively large open lumen, blood flow through the balloon can continue even as the inflated balloon remains in place. This allows an extended period of inflation without the side effects attendant with conventional balloons (such as chest pain, etc.). Moreover, the diameter of the central lumen can allow for blood flow equivalent to or greater than the Stack-type balloon, without the size and rigidity problems experienced by those balloons.
Although the turns of the coiled balloon preferably abut one another, in certain embodiments one or`more spa~es in the helical coil wall can be provided (by spacing successive`turns from one another) to facilitate blood flow through arterial side branches that otherwi~e would ~e occluded by conventional balloons (including Stack-type balloons). The helical balloon can also be easily configur~d to have a predetermined bend (or flexibility to bend) for procedures at or very near sharp arteriil bends, such as by pre-configuring the balloon with a bend or by providing spaces in the hèlical coil to give it greater flexibility at certain points. `` ` ~ -BRIEF~DESCRIPTION OF THE DRAWINGS
Figure 1 shows a helical balloon catheter of theinvention; ~ -Figure 2 shows the balloon catheter of Figure 1advanced into an artherosclerotic artery and partially inflated;
Figure 3 shows the balloon catheter of Figure 2 fully inflated with a perfusion or contrast injection :, '` .
~ . wos2/l8l~ PCTrUS92/03~ ~
catheter advanced over the guide wire;
Figure 4 shows the balloon catheter of the invention in its furled configuration being advanced into an artherosclerotic artery, with a pushing catheter advanced over the guide wire;
Figure 5 shows the balloon catheter of Figure 1 in a slightly different configuration;
Figure 6 shows yet another configuration of the balloon catheter:
Figure 7 shows yet a further embodiment bf the balloon catheter;
Figure 8 shows yet a further embodiment of the balloon catheter;
Figure 9 shows yet another embodiment of the balloon catheter where the tube is folded back upon itself and wound in a double helix fashion;
Figure 10 shows yet another helical balloon catheter having three helically wound tubes;
Figure 11 shows yet another embodiment of the balloon catheter~
Figure 12 shows another embodiment having a space between successive turns of the balloon to permit circulation through a side branch artery;
Figure 13 shows another embodiment having a space between successive turns of the balloon to give the balloon~greater flexibility at a midpoint for use at a~ harp~bend in an artery;
Figure 14~shows another:embodiment having a ~ . .. , . ~ . . . ...... . .
pre-determined.curve;
Figure lS shows a tube that can be wound into the oonfiguration shown in Figure 14,-with ~igures 15A-lSC showing selective cross-sections through lines , t lSA-lSA, lSB-lSB, and lSC-lSC, respectively;
Figure 16 shows a helical balloon catheter having an outer sheath; and ,~
.~ '' WO 92/18195 ' PCI~/USg2/032&3 _ 5 210~og5 Figure 17 shows a slightly different embodiment ~ of the helical catheter used as an introducer catheter.
t BEST MODE FOR QRRYING OUT THE INV~ION
- Figure 1 depicts generally a helical balloo~
catheter of the invention. The balloon catheter of the invention preferably is comprised of a small thin walled, collapsable tube 32 wound into a helical coil to form a generally cylindrical inflatable balloon i portion that has a large open lumen 34 therethrough.
The lumen 34 therefore presents a substantially open passageway both distally and proximally, allowing blood to continue flowing through the balloon even when it is inflated.
Successive turns of the helical tube 32 abut one ' another and are held in position either by adhesive or similar means and/or the intermediate portions 45 of the longitudinal straps 94. In this particular embodiment the straps 94 are attached to a central guide wire 39 at their distal ends 44, and are also ~` attached to the guide wire 39 proximally of the heliaal portion of the balloon. The proximal portion 36 of the tube 32 itself may also be attached to the guide wire 39. so that the stresses of advancement and withdrawal of the balloon are born by the guide wire ~ 39 and the ætraps 94, not the tube 32. Such distal !j~ and proximal fixation of the straps 94 to the guide wire 39 also longitudinally secures the location of the helical balloon`with`~rèspect to the guide wire 39. An inflation device 80 is connected to the proximal portion 36 of the tube 32 for inflating and deflating the helical balloon.
Figure 2 depicts the balloon of Figure 1 in its partially inflated configuration, ha~ing been advanced into an artery 95-to a narrowed atherosclerotic portion 96 of the artery 95. In Figure 3, the balloon ,t ~ t'`' i ~ W092/18195 PCT/US92/03~
.
2 1O9~gS - 6 -has been inflated to expand the the stenotic segment 96 of the artery 95. Because the helical configuration of the balloon catheter provides a large, open lumen 34 when inflated, blood flow through the artery 95 can continue as the angioplasty is being A, performed, and the balloon can be left inflated for ; some period of time without restricting blood flow through the artery 95.
' If desired, a catheter 41 can be advanced over s the guide wire 39 to a position just proximal of the helical portion of the balloon, as shown in Figure 3.
l This is useful, e.g., for injecting radiographic s contrast to aid in imaging or to perfuse the artery with blood or other solutions from an
' If desired, a catheter 41 can be advanced over s the guide wire 39 to a position just proximal of the helical portion of the balloon, as shown in Figure 3.
l This is useful, e.g., for injecting radiographic s contrast to aid in imaging or to perfuse the artery with blood or other solutions from an
3 extra-corporeally located device. Blood autoperfusion through the helical balloon catheter may also be enhanced by blood entering side holes in a proximal portion of the catheter 41, e.g., when the balloon catheter is inserted through the aorta to a coronary artery, the blood enters the catheter 41 side holes in the a~rta and then travels through the catheter 41 into the coronary artery and through the helical balloon. The catheter 41 may be made of a much larger diameter than the Stack-type catheters because the , balloon is not mounted on it, and in some situations :~ the diameter of the catheter ~1 may approach the ~; ~ diameter~of the inflated helioal balloon placed across the ~tenotic area, providing significant flow therethrough. When a relatively large diameter catheter 41 is used, it may also serve as a guiding catheter to facilitate balloon catheter/guide wire ~- exchanges.
Figure 4 shows that a pushing catheter 42 may - also be used to enhance the pushability of the furled helical balloon catheter by transmitting pushing force ,: .
~ W092/181~ PCT/USg2/03~3 21~909~
directly to the furled balloon portion (in addition to the pushing force exerted by the physician on the guide wire 39 itself). The pushing catheter 42 may be advanced over the guide wire 39 to a position abutting the proximal end of the furled balloon portion for assistance in pushing only when actually needed, e.g., for the final push in advancing the balloon portion across the stenotic segment of the artery. Moreover, the pushing catheter may be partially withdrawn or entirely removed once the balloon is in place 50 as not to impede blood flow through the artery.
Figure 5 shows a slightly modified embodiment of the invention-- In this embodiment the straps 94 and tube 32 are not attached to the guide wire 39 proximally of the helical portion so that a more rigid catheter 97 can be adva ~ed over the guide wire 39 beyond the helical portlon of thè balloon. This is useful, e.g., for increasing the pushability of the guide wire 39. The distal end of this catheter 97 engages the straps 94 near their distal ends 44, pu}ling the balloon along as the catheter 97 and guide wire 39 are advanced through the artery 9S. Figure 6 shows a modification of this embodiment where the guide wire 39 i~ provided with a flange 98 that is engagable by the distal tip of the catheter 97 to eliminate stress on~the straps 94 as the catheter 97 is `U8ed` to assist in the advancement of the guide wire 39~and balloon.~
Figure 7 illustrates an alternate embodiment wherein the straps 94 are attached to a catheter 99 instead of to the guide wire 39. This allows independent advancement and withdrawal of the guide wire 39, but takes up more space in the lumen 34 of the balloon. An additional catheter (not shown) may also be advanced over the catheter 99 until it pushes ~: .
.:;
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:~W092/~8195`~ PCT/US92/03~3 . . .
on the furled balloon, thus further increasing pushability of the system.
Figure 8 shows yet another embodiment wherein the distal ends 44 of the straps 94 return proximally through the central lumen of the catheter 99. In this embodiment, the catheter 99 can be advanced or retracted separately with respect to the balloon, but when the physician grasps the distal and proximal ends 44 and 46 of the straps 94 along with the catheter 99 and simultaneously advances or retracts the catheter 99, the balloon will advance/retract as well (since the intermediate portions 45 of the straps are attached to the coiled tube 32~.
Figure 9 ~hows another configuration for the helical tube 32 in which the helix is formed by a double winding of tube 32, the tube windings being connected to one another at the distal end 37 of the balloon 80 that, in effect, the balloon consists of a double helical wi~ding of a single tube folded back on it~elf. In this configuration, the inflation fluid flows.into the balloon through one of the windings proximally to distally, and then returns through the other winding dista1ly to proximally. The tube 32 may theref:ore be entirely flushed of air bubbles, etc., as~uring that no air is~entrained in the helical tube should the tube burst while.in the patient. Figure 9 hows-the.inflation/flushing device;80 injecting fluid through the tube, with the fluid exiting through the ~ .
open stop cock 38 at the opposite end of the tube 32.
Figure lO illustrates that a triple helical winding may also be utilized:.if desired to form the balloon. The three tubes 32 forming the balloon are attached to the guide wire 39 both distally and proximally of the helical portion of the balloon, their proximal portions 36 being attached to the :
:: `
WO92~181~ ~ PCT/US92/03~3 - 9 - 21 09 09 a , inflation device 80. Figure lO also shows an t alternate arrangement for the straps 94. In this embodiment, the straps 94 are merely fastened around the helical winding~, and do not return proximally.
Figure ll shows yet another configuration in which the helical windings are attached along one side ' directly to the guide wire 39, eliminating the need for straps 94 entirely. This configuration has the disadvantage that the balloon is not centered about the guide wire 39 when inflated, even though t~e need for straps is eliminated.
Referring to Figure 12, if the stenotic segment ~ 96 is located such that the balloon, when inflated, i would occlude a side branch 90 of the artery g5, then ~ a modified helical balloon could be ultilized that I includes a side opening 9l, formed by spacing two ~ adjacent turns of the coiled tubè 32 slightly from one ¦ another. This allows blood to flow out of the lumen 34 into the side branch 90. If desired, radiopaque markers 85 may be placed on the guide wire 39 and/or on the straps 94 to indicate both the longitudinal location of the side opening 9l and the rotational position of the balloon 80 that the opening 9l in the balloon can bé selectively advanced/withdrawn or rotated to the most desirabl~ position.
Figure 13 il1ustrates another embodiment having ;. a simi1ar opening 9l in the helicaI balloon. This opening 9l allows the balloon to bend quite ~ dramatically for placement in a bend 89 of the artery 3 95. The relative lengths of the intermediate portions 45 of the straps 94 ean be pre-selected to permit only ~ ~ one side of the balloon to open, thus keeping 1~ successive turns of the tube opposite the opening close together, as shown in Figure 12. Again, radiopaque markers 85 may be used to assist in imaging :
~:
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,~ ~ .
~ ~WO ~/18195 PCT/US92/03~3 ~1~9095 - lO-~................ .
of the longitudinal and rotational position of the balloon.
Figures 14-15 illustrate another technique for manufacturing a balloon with a desired bend. In this embodiment, the tube 32 is manufactured with alternating larger and smaller diameters, as shown in ~igure 15. When wound about a mandrel of the proper corresponding diameter, the larger diameter portions 50 of the tube 32 allign on one side, and the smaller diameter portions 51 allign on the other side, giving the coil a natural bend when inflated.
Figure 16 illustrates one possible technique for ~ manufacturing the helical balloon. The tube 32 may be i;~ wound into a coiled tube, and then the turns may be .
secured by either an inner skin or an outer-skin 93 as shown in Figure 15. Such a skin may be formed by applying a thin layer of adhesive, by securing a thin layer of silicone, or by other conventional means.
The thin inner or outer skin 93 may be applied so thinly that it does not significantly change the shape of the undulating surface, or it may be applied somewhat thicker to smooth out the grooves between successive turns of the tube 32, thereby presenting a smooth surface which can be advantageous in certain circumstances. Other æimilar techniques may also be ~ utilized to produce the desired configuration.
¦ ~ Figure 17-illustrates an alternate application for use of the helical balloon of the invention in introducing an over-sized device (indicated sch~matically as 103), for example, through an - arthrosclerotic femoral/iliac artery. Here, the helical balloon is advanced while deflated through the femoral/iliac artery 95 to the wider aorta. When the ~; distal end of the balloon has reached the aorta, it may be inflated to present a generally smooth and i WO ~/18195~3 rcTrusg2n3~
- ll 210909~ ' somewhat straighter pathway for the introduction of devices past arthrosclerotic plaques 96. The use of the inner s~in 93 is shown in this embodiment.
While a preferred embodiment of the present invention has been described, it should be understood that various changes, adaptations and modifications may be made therein without departing from the spirit of the invention and the scope of the appended claims.
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Figure 4 shows that a pushing catheter 42 may - also be used to enhance the pushability of the furled helical balloon catheter by transmitting pushing force ,: .
~ W092/181~ PCT/USg2/03~3 21~909~
directly to the furled balloon portion (in addition to the pushing force exerted by the physician on the guide wire 39 itself). The pushing catheter 42 may be advanced over the guide wire 39 to a position abutting the proximal end of the furled balloon portion for assistance in pushing only when actually needed, e.g., for the final push in advancing the balloon portion across the stenotic segment of the artery. Moreover, the pushing catheter may be partially withdrawn or entirely removed once the balloon is in place 50 as not to impede blood flow through the artery.
Figure 5 shows a slightly modified embodiment of the invention-- In this embodiment the straps 94 and tube 32 are not attached to the guide wire 39 proximally of the helical portion so that a more rigid catheter 97 can be adva ~ed over the guide wire 39 beyond the helical portlon of thè balloon. This is useful, e.g., for increasing the pushability of the guide wire 39. The distal end of this catheter 97 engages the straps 94 near their distal ends 44, pu}ling the balloon along as the catheter 97 and guide wire 39 are advanced through the artery 9S. Figure 6 shows a modification of this embodiment where the guide wire 39 i~ provided with a flange 98 that is engagable by the distal tip of the catheter 97 to eliminate stress on~the straps 94 as the catheter 97 is `U8ed` to assist in the advancement of the guide wire 39~and balloon.~
Figure 7 illustrates an alternate embodiment wherein the straps 94 are attached to a catheter 99 instead of to the guide wire 39. This allows independent advancement and withdrawal of the guide wire 39, but takes up more space in the lumen 34 of the balloon. An additional catheter (not shown) may also be advanced over the catheter 99 until it pushes ~: .
.:;
:~
;~`
:~W092/~8195`~ PCT/US92/03~3 . . .
on the furled balloon, thus further increasing pushability of the system.
Figure 8 shows yet another embodiment wherein the distal ends 44 of the straps 94 return proximally through the central lumen of the catheter 99. In this embodiment, the catheter 99 can be advanced or retracted separately with respect to the balloon, but when the physician grasps the distal and proximal ends 44 and 46 of the straps 94 along with the catheter 99 and simultaneously advances or retracts the catheter 99, the balloon will advance/retract as well (since the intermediate portions 45 of the straps are attached to the coiled tube 32~.
Figure 9 ~hows another configuration for the helical tube 32 in which the helix is formed by a double winding of tube 32, the tube windings being connected to one another at the distal end 37 of the balloon 80 that, in effect, the balloon consists of a double helical wi~ding of a single tube folded back on it~elf. In this configuration, the inflation fluid flows.into the balloon through one of the windings proximally to distally, and then returns through the other winding dista1ly to proximally. The tube 32 may theref:ore be entirely flushed of air bubbles, etc., as~uring that no air is~entrained in the helical tube should the tube burst while.in the patient. Figure 9 hows-the.inflation/flushing device;80 injecting fluid through the tube, with the fluid exiting through the ~ .
open stop cock 38 at the opposite end of the tube 32.
Figure lO illustrates that a triple helical winding may also be utilized:.if desired to form the balloon. The three tubes 32 forming the balloon are attached to the guide wire 39 both distally and proximally of the helical portion of the balloon, their proximal portions 36 being attached to the :
:: `
WO92~181~ ~ PCT/US92/03~3 - 9 - 21 09 09 a , inflation device 80. Figure lO also shows an t alternate arrangement for the straps 94. In this embodiment, the straps 94 are merely fastened around the helical winding~, and do not return proximally.
Figure ll shows yet another configuration in which the helical windings are attached along one side ' directly to the guide wire 39, eliminating the need for straps 94 entirely. This configuration has the disadvantage that the balloon is not centered about the guide wire 39 when inflated, even though t~e need for straps is eliminated.
Referring to Figure 12, if the stenotic segment ~ 96 is located such that the balloon, when inflated, i would occlude a side branch 90 of the artery g5, then ~ a modified helical balloon could be ultilized that I includes a side opening 9l, formed by spacing two ~ adjacent turns of the coiled tubè 32 slightly from one ¦ another. This allows blood to flow out of the lumen 34 into the side branch 90. If desired, radiopaque markers 85 may be placed on the guide wire 39 and/or on the straps 94 to indicate both the longitudinal location of the side opening 9l and the rotational position of the balloon 80 that the opening 9l in the balloon can bé selectively advanced/withdrawn or rotated to the most desirabl~ position.
Figure 13 il1ustrates another embodiment having ;. a simi1ar opening 9l in the helicaI balloon. This opening 9l allows the balloon to bend quite ~ dramatically for placement in a bend 89 of the artery 3 95. The relative lengths of the intermediate portions 45 of the straps 94 ean be pre-selected to permit only ~ ~ one side of the balloon to open, thus keeping 1~ successive turns of the tube opposite the opening close together, as shown in Figure 12. Again, radiopaque markers 85 may be used to assist in imaging :
~:
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~ ~WO ~/18195 PCT/US92/03~3 ~1~9095 - lO-~................ .
of the longitudinal and rotational position of the balloon.
Figures 14-15 illustrate another technique for manufacturing a balloon with a desired bend. In this embodiment, the tube 32 is manufactured with alternating larger and smaller diameters, as shown in ~igure 15. When wound about a mandrel of the proper corresponding diameter, the larger diameter portions 50 of the tube 32 allign on one side, and the smaller diameter portions 51 allign on the other side, giving the coil a natural bend when inflated.
Figure 16 illustrates one possible technique for ~ manufacturing the helical balloon. The tube 32 may be i;~ wound into a coiled tube, and then the turns may be .
secured by either an inner skin or an outer-skin 93 as shown in Figure 15. Such a skin may be formed by applying a thin layer of adhesive, by securing a thin layer of silicone, or by other conventional means.
The thin inner or outer skin 93 may be applied so thinly that it does not significantly change the shape of the undulating surface, or it may be applied somewhat thicker to smooth out the grooves between successive turns of the tube 32, thereby presenting a smooth surface which can be advantageous in certain circumstances. Other æimilar techniques may also be ~ utilized to produce the desired configuration.
¦ ~ Figure 17-illustrates an alternate application for use of the helical balloon of the invention in introducing an over-sized device (indicated sch~matically as 103), for example, through an - arthrosclerotic femoral/iliac artery. Here, the helical balloon is advanced while deflated through the femoral/iliac artery 95 to the wider aorta. When the ~; distal end of the balloon has reached the aorta, it may be inflated to present a generally smooth and i WO ~/18195~3 rcTrusg2n3~
- ll 210909~ ' somewhat straighter pathway for the introduction of devices past arthrosclerotic plaques 96. The use of the inner s~in 93 is shown in this embodiment.
While a preferred embodiment of the present invention has been described, it should be understood that various changes, adaptations and modifications may be made therein without departing from the spirit of the invention and the scope of the appended claims.
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Claims (31)
1. A helical balloon catheter comprising an inflatable tube having a proximal, generally straight portion and a distal, helically coiled portion, the helically coiled portion being inflatable from a deflated, furled configuration having a relatively smaller inner and outer diameter to an inflated, unfurled configuration having a relatively larger inner and outer diameter and defining a generally open, central lumen, the balloon further including means for securing turns of the coiled portion with respect to one another.
2. The balloon catheter of claim 1 wherein at least some of the successive turns of the coiled portion abut one another.
3. The balloon catheter of claim 1 wherein the means for securing comprises a flexible skin attached to at least some of the turns of the coil.
4. The balloon catheter of claim 1 further including advancing means for selectively advancing and retracting the coiled portion of the balloon in a bodily passageway.
5. The balloon catheter of claim 4 wherein the advancing means comprises a generally central shaft and attachment means for attaching the coiled portion of the balloon to the shaft.
6. The balloon catheter of claim 5 wherein the shaft comprises a guide wire.
7. The balloon catheter of claim 6 wherein the shaft comprises a catheter.
8. The balloon catheter of claim 5 wherein the balloon is collapsable and capable of being furled closely about the shaft.
9. The balloon catheter of claim 5 further comprising a pushing catheter advancable over the shaft, the pushing catheter having a distal end for pushing against the balloon when it is furled about the shaft.
10. The balloon catheter of claim 5 wherein the attachment means comprises straps having distal, proximal, and intermediate portions.
11. The balloon catheter of claim 10 wherein the distal portions of the straps are attached to the shaft and the intermediate portions of the straps are attached to the coiled portion of the balloon catheter.
12. The balloon catheter of claim 10 wherein the intermediate portions of the straps are attached to the coiled portion of the balloon, and wherein the shaft comprises a catheter having a distal end and a lumen through which the distal portions of the straps may be threaded so that the catheter can be advanced with its distal end engaging the straps near their intermediate portions to advance the balloon catheter.
13. The balloon catheter of claim 10 wherein the distal portions of the straps are attached to the shaft, and the intermediate portions of the straps are attached to the coiled portion of the balloon, and further comprising a pushability catheter advancable over the shaft and having a distal end so that the pushability catheter can be advanced over the shaft with its distal end engaging the straps near their distal ends to advance the balloon catheter.
14. The balloon catheter of claim 13 further comprising a stop carried on the shaft so that the distal end of the pushability catheter engages the stop rather than the straps.
15. The balloon catheter of claim 2 wherein one of the turns of the coiled portion is spaced from a successive turn to form a gap in the coiled portion, permitting perfusion of a branch artery when the balloon is inflated.
16. The balloon catheter of claim 1 including two such inflatable tubes, their coiled portions being coiled in a double helical configuration and being in fluid communication with one another at their distal ends.
17. The balloon catheter of claim 16 wherein the proximal portion of one of the tubes is attachable to an inflation device and the proximal portion of the other tube includes a stopcock that is openable to allow purging of the tube and closable to allow the balloon to be inflated.
18. The balloon catheter of claim 1 wherein the inflatable tube includes first and second ends and is folded upon itself intermediate its ends, the coiled portion thereby comprising a double helical coil adjacent the fold.
19. The balloon catheter of claim 18 wherein the first end of the tube is attachable to an inflation device and the second end of the tube includes a stopcock that is openable to allow purging of the tube and closable to allow the balloon to be inflated.
20. The balloon catheter of claim 1 further comprising a shaft disposed within the lumen, the shaft having a surface that is attached to the turns of the coiled portion.
21. A balloon catheter comprising:
an inflatable tube having a proximal, generally straight portion and a distal, coiled, generally cylindrical portion defining an open, central lumen, at least some of the successive turns of the coiled portion abutting one another;
means for securing turns of the coiled portion with respect to one another including a flexible skin attached to at least some of the turns of the coil; and attachment means for attaching the coiled portion of the balloon to a guide wire, comprising straps having distal, proximal, and intermediate portions, the distal portions of the straps being attached to the guide wire and the intermediate portions of the straps being attached to the coiled portion.
an inflatable tube having a proximal, generally straight portion and a distal, coiled, generally cylindrical portion defining an open, central lumen, at least some of the successive turns of the coiled portion abutting one another;
means for securing turns of the coiled portion with respect to one another including a flexible skin attached to at least some of the turns of the coil; and attachment means for attaching the coiled portion of the balloon to a guide wire, comprising straps having distal, proximal, and intermediate portions, the distal portions of the straps being attached to the guide wire and the intermediate portions of the straps being attached to the coiled portion.
22. A balloon catheter comprising a distal, helically coiled, generally cylindrical inflatable sheath portion defining a proximally and distally open lumen, the helically coiled portion being inflatable from a deflated, furled configuration having a relatively smaller inner and outer diameter to an inflated, unfurled configuration having a relatively larger inner and outer diameter, the balloon catheter further including an inflation tube: extending proximally from the inflatable sheath portion, and means for advancing and retracting the inflatable sheath portion through a passageway.
23. The balloon catheter of claim 22 wherein the means for advancing and retracting the sheath comprises a shaft attached to the inflatable sheath.
24. The balloon catheter of claim 22 wherein the advancing and retracting means comprises a generally central shaft and attachment means for attaching the inflatable sheath portion of the balloon to the shaft.
25. The balloon catheter of claim 24 wherein the shaft comprises a guide wire.
26. The balloon catheter of claim 24 wherein the shaft comprises a catheter.
27. The balloon catheter of claim 22 wherein the means for advancing and retracting the sheath comprises.
a plurality of straps having proximal, intermediate, and distal portions, the intermediate portions of the straps being attached to the inflatable sheath, and the distal portions of the straps are attached to the shaft.
a plurality of straps having proximal, intermediate, and distal portions, the intermediate portions of the straps being attached to the inflatable sheath, and the distal portions of the straps are attached to the shaft.
28. The balloon catheter of claim 27 futher comprising a pushing catheter advancable over the shaft, the pushing catheter having a distal end for pushing against the balloon when it is furled about the shaft.
29. The balloon catheter of claim 27 wherein the intermediate portions of the straps are attached to the inflatable sheath portion of the balloon, and wherein the shaft comprises a catheter having a distal end and a lumen through which the distal portions of the straps may be threaded so that the catheter can be advanced with its distal end engaging the straps near their intermediate portions to advance the balloon catheter.
30. The balloon catheter of claim 22 wherein the internal diameter of the open lumen through the inflatable sheath portion is at least about one third of the outer diameter of the inflatable sheath portion.
31. The balloon catheter of claim 22 wherein the internal diameter of the open lumen through the inflatable sheath portion is at least about one half of the outer diameter of the inflatable sheath portion.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/689,361 US5181911A (en) | 1991-04-22 | 1991-04-22 | Helical balloon perfusion angioplasty catheter |
| US689,361 | 1991-04-22 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2109095A1 true CA2109095A1 (en) | 1992-10-23 |
Family
ID=24768116
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002109095A Abandoned CA2109095A1 (en) | 1991-04-22 | 1992-04-21 | Helical balloon perfusion angioplasty catheter |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US5181911A (en) |
| EP (1) | EP0581900B1 (en) |
| JP (1) | JP3442386B2 (en) |
| AT (1) | ATE162952T1 (en) |
| AU (1) | AU664707B2 (en) |
| CA (1) | CA2109095A1 (en) |
| DE (1) | DE69224379T2 (en) |
| DK (1) | DK0581900T3 (en) |
| UA (1) | UA39857C2 (en) |
| WO (1) | WO1992018195A1 (en) |
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| US11752310B2 (en) * | 2015-11-06 | 2023-09-12 | C.R. Bard, Inc. | Perfusion balloon with a selectively actuatable valve |
| US10625058B2 (en) | 2016-03-04 | 2020-04-21 | C.R. Bard, Inc. | Perfusion balloon with external valve |
| US11565090B2 (en) | 2016-03-04 | 2023-01-31 | C.R. Bard, Inc. | Perfusion balloon with internal valve |
| US10245050B2 (en) | 2016-09-30 | 2019-04-02 | Teleflex Innovations S.À.R.L. | Methods for facilitating revascularization of occlusion |
| US10918390B2 (en) * | 2018-03-30 | 2021-02-16 | DePuy Synthes Products, Inc. | Helical balloon assist device and method for using the same |
| US10786259B2 (en) | 2018-03-30 | 2020-09-29 | DePuy Synthes Products, Inc. | Split balloon assist device and method for using the same |
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|---|---|---|---|---|
| US1245325A (en) * | 1916-04-11 | 1917-11-06 | Sola B Dunn | Veterinary instrument. |
| US3438375A (en) * | 1966-03-18 | 1969-04-15 | Kendall & Co | Non-traumatic retention catheter |
| US3485237A (en) * | 1967-03-20 | 1969-12-23 | Rca Corp | Self-propelling hose |
| US4030503A (en) * | 1975-11-05 | 1977-06-21 | Clark Iii William T | Embolectomy catheter |
| US4183102A (en) * | 1977-09-08 | 1980-01-15 | Jacques Guiset | Inflatable prosthetic device for lining a body duct |
| DE3235974A1 (en) * | 1981-11-24 | 1983-06-01 | Volkmar Dipl.-Ing. Merkel (FH), 8520 Erlangen | DEVICE FOR REMOVAL OR FOR THE EXPANSION OF CONSTRAINTS IN BODY LIQUID LEADING VESSELS |
| US4515587A (en) * | 1983-02-14 | 1985-05-07 | Smec, Inc. | IAB having apparatus for assuring proper balloon inflation and deflation |
| US4706671A (en) * | 1985-05-02 | 1987-11-17 | Weinrib Harry P | Catheter with coiled tip |
| US4681564A (en) * | 1985-10-21 | 1987-07-21 | Landreneau Michael D | Catheter assembly having balloon extended flow path |
| US4762130A (en) * | 1987-01-15 | 1988-08-09 | Thomas J. Fogarty | Catheter with corkscrew-like balloon |
| US4934786A (en) * | 1989-08-07 | 1990-06-19 | Welch Allyn, Inc. | Walking borescope |
-
1991
- 1991-04-22 US US07/689,361 patent/US5181911A/en not_active Expired - Lifetime
-
1992
- 1992-04-21 WO PCT/US1992/003283 patent/WO1992018195A1/en active IP Right Grant
- 1992-04-21 DK DK92914157T patent/DK0581900T3/en active
- 1992-04-21 JP JP51176192A patent/JP3442386B2/en not_active Expired - Fee Related
- 1992-04-21 EP EP92914157A patent/EP0581900B1/en not_active Expired - Lifetime
- 1992-04-21 DE DE69224379T patent/DE69224379T2/en not_active Expired - Fee Related
- 1992-04-21 CA CA002109095A patent/CA2109095A1/en not_active Abandoned
- 1992-04-21 UA UA93004613A patent/UA39857C2/en unknown
- 1992-04-21 AT AT92914157T patent/ATE162952T1/en not_active IP Right Cessation
- 1992-04-21 AU AU21838/92A patent/AU664707B2/en not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| DE69224379T2 (en) | 1998-07-16 |
| WO1992018195A1 (en) | 1992-10-29 |
| EP0581900B1 (en) | 1998-02-04 |
| JPH06509722A (en) | 1994-11-02 |
| AU2183892A (en) | 1992-11-17 |
| ATE162952T1 (en) | 1998-02-15 |
| EP0581900A4 (en) | 1993-12-14 |
| DK0581900T3 (en) | 1998-09-23 |
| DE69224379D1 (en) | 1998-03-12 |
| JP3442386B2 (en) | 2003-09-02 |
| AU664707B2 (en) | 1995-11-30 |
| US5181911A (en) | 1993-01-26 |
| UA39857C2 (en) | 2001-07-16 |
| EP0581900A1 (en) | 1994-02-09 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |