CA1186582A - Cardiovascular catheter and method of manufacture - Google Patents
Cardiovascular catheter and method of manufactureInfo
- Publication number
- CA1186582A CA1186582A CA000420455A CA420455A CA1186582A CA 1186582 A CA1186582 A CA 1186582A CA 000420455 A CA000420455 A CA 000420455A CA 420455 A CA420455 A CA 420455A CA 1186582 A CA1186582 A CA 1186582A
- Authority
- CA
- Canada
- Prior art keywords
- catheter
- plastic member
- ribbon
- body passage
- tubular plastic
- 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.)
- Expired
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- Media Introduction/Drainage Providing Device (AREA)
Abstract
ABSTRACT
Catheter for insertion into the cardiovascular system, and method of manufacturing the same. A helically wound filament of flexible material is imbedded in the wall of the catheter to provide a torsional rigidity which facilitates steering and turning of the catheter during emplacement. The stiffness of the catheter is controlled by varying the pitch of the helically wound filament.
Catheter for insertion into the cardiovascular system, and method of manufacturing the same. A helically wound filament of flexible material is imbedded in the wall of the catheter to provide a torsional rigidity which facilitates steering and turning of the catheter during emplacement. The stiffness of the catheter is controlled by varying the pitch of the helically wound filament.
Description
A-37711 CARDIOVASCULAR CATHETER AND METHOD OF M~NUFACTURE
This invention pertains generally to catheters for insertion into the cardiovascular system, and more particularly to a catheter which can be steered or turned as it is inserted and to a method of manufacturing the same.
Guiding catheters and other catheters (e.g. balloon catheters and angiographic catheters) which are inserted into the cardiovascular system must, at times, be turned and steered in order to achieve the desired placement. With many catheters heretofore provided, this process is difficult because the catheters tend to twist and untwist in an unpredictable manner as they are turned in an effort to steer them~
In an attempt to overcome this problem, some catheters have been provided with a wire braid (e.g. stainless steel) imbedded in the wall of the catheter. While the wire braid does provide some stiffening, and therefore better control, the wire tends to be brittle if made fine enough not to increase the thickness of the wall by an appreciable amount.
While the use of a heavier wire might overcome the problem of breakage, it would require a thicker wall and would, therefore, increase the outer diame-ter of the catheter and/or decrease the size of the central passageway or lumen.
Either of these alternatives would be contrary to the fundamental objective of providing the largest possible lumen and the smallest possib~e outer diameter so that the catheter will fit in a relatively small opening in the body. In addition, the manufacture of a catheter having a wire braid imbedded therein is relatively time consuming and expensive.
It is in genexal an ob~ect of the invention to provide a new and improved cardiovascular catheter and method of manufacturing the same.
Another object of the invention is to prov:Lde a catheter of the above character having torsional rigidity and a relatively thin wall thickness.
Another object of the invention is to provide a catheter and method of the above character in which the stiffness of the catheter can be controlled along the length of the cathe-ter.
Another object of the invention is to provide a catheter and method of the above character in which the catheter can be manufactured quickly and economically.
These and other objects are achieved in accordance with the invention by providing a catheter and a method of manufacturing the same wherein a length of flexible filament is wound in helical fashion about the lumen or passageway of the catheter.
In one embodiment, the flexible filament is wrapped about a tubular inner liner which defines the lumen, an outer jacket is formed over the filament, and the inner liner, the filament 2Q and the outer jacket are bonded together to form a unitary structure with torsional rigi~ity~ The pitch of the helically wound filament can be varied along the length of the linèr to vary the stiffness of the catheter.
Figure 1 is an elevational view, partly broken away, of one ~5 embodiment of a cardiovascular catheter incorporating the invention.
Figure ~ is an isometric view, somewhat schematic, of apparatus employed in one embodiment of a method of manufacturing the catheter of Figure 1.
As illustrated in Figure 1, the catheter (cles:igllatecl generally as 11) comprises a tubular i.nner liner 12 whi.ch defines all axially extending passageway or llmlen 13. l,iner 12 is -Fabricatecl o-f a flex;.ble, relatively slippery material such as polyte-trof]uoroe-thylerle (Teflon), with a relatively thin wall thiclcness, e.g. .0U3 inC]l.
An elongated -Filament 16 o:F flexible material is wrapped in helical fashion about the outer wall o:F liner 12 to give torsional rigidity to the catheter. In the embodiment illustrated, the filament is wrapped in two layers 17, 18 of opposite pitch, and the filament comprises a generally flat ribbon having a thickness on the order of .001 inch. In one presently preferred embodiment, the :Filament comprises a carbon -Filament having approxilllately 1,000 :incl:ividunl stral-cls -Formed into a bunclle o-f the cles.i.recl flat shape.
ln allotller, alld presently pre:Fcrred cmbodilllent, the f.i:lalllent comprises a 380 denier Kevlar (DuPont Trademarli) :fiber. This fiber is an aromatic polyamide material which has the advantage of being rela-tively flexible and less likely to break than a more brit-tle fiber.
}lowever, it will be understood that other :flexible fibers o:F high tensile strengt}- (i.e. 250,000 lbs./in.2!, such as boron filaments, can be used. Likewise, more than two layers of -Filament can be employ-ecl, if desirecl.
The pi-tc]-l o:F the filament windings can be variecl along the length of the liner to vary the stiffness of the catheter. In the embodiment of Figure 1, or example, the pitch is greater in regions 21, 22 toward the ends of the catheter than in central regi.on 23, and this catheter is stiffer in the central region than toward the ends.
- 3a -An outer jacket 26 o:E flex:ible ma-ter:ial :is formed over the outer layer 18 of Lilament 16 iand encases the :Filament. This jacket is fabricated oE a tllermop:Lastic materi.ll such as po:Ly-etllylene whic]l can be sterilized so as not to contamillate the body into which it is inserted. In one presently preferred embod:imen-t~
the outer jacket is fabricated oE a heat shrinkable tubing which is drawn tightly about the inner liner and the windings o:E
filament.
~4--Inner liner 12, filament 16 and outer jacket 26 are bonded together by suitable means such as epoxy to form a unitary structure. The unitary nature of the structure has been found to improve the torsional rigidity of the catheter and thereby facilitate turning and steering of the catheter during emplacement in the body.
A connecter 28, illustrated as a female Luer fitting, is attached to the inlet end of the catheter, and the distal end 29 can be formed with any desired bend, as in conventional guiding catheters.
Referring now to Figure 2, a preferred method of manufacturing the catheter is illustrated. Inner liner 12 is mounted on a wire-like mandrel 31 which extends axially through the opening in the tubing which forms the liner. To facilitate later removal, a lubricant such as silicon is applied to the mandrel before it is inserted into the tubing. The tubing is then temporarily affixed to the mandrel by suitable means, and in presently preferred embodiment the liner is fabricated of a heat shrinkable tubing which is heated and shrunk about the mandrel.
Mandrel 31 is mounted between the chucks 32, 33 of a winding machine 34 and drawn taut by suitable means such as a spring 36. A drive motor 37 is connected to chuck 32 to rotate the same about its axis, and chuck 33 is provided with a bearing
This invention pertains generally to catheters for insertion into the cardiovascular system, and more particularly to a catheter which can be steered or turned as it is inserted and to a method of manufacturing the same.
Guiding catheters and other catheters (e.g. balloon catheters and angiographic catheters) which are inserted into the cardiovascular system must, at times, be turned and steered in order to achieve the desired placement. With many catheters heretofore provided, this process is difficult because the catheters tend to twist and untwist in an unpredictable manner as they are turned in an effort to steer them~
In an attempt to overcome this problem, some catheters have been provided with a wire braid (e.g. stainless steel) imbedded in the wall of the catheter. While the wire braid does provide some stiffening, and therefore better control, the wire tends to be brittle if made fine enough not to increase the thickness of the wall by an appreciable amount.
While the use of a heavier wire might overcome the problem of breakage, it would require a thicker wall and would, therefore, increase the outer diame-ter of the catheter and/or decrease the size of the central passageway or lumen.
Either of these alternatives would be contrary to the fundamental objective of providing the largest possible lumen and the smallest possib~e outer diameter so that the catheter will fit in a relatively small opening in the body. In addition, the manufacture of a catheter having a wire braid imbedded therein is relatively time consuming and expensive.
It is in genexal an ob~ect of the invention to provide a new and improved cardiovascular catheter and method of manufacturing the same.
Another object of the invention is to prov:Lde a catheter of the above character having torsional rigidity and a relatively thin wall thickness.
Another object of the invention is to provide a catheter and method of the above character in which the stiffness of the catheter can be controlled along the length of the cathe-ter.
Another object of the invention is to provide a catheter and method of the above character in which the catheter can be manufactured quickly and economically.
These and other objects are achieved in accordance with the invention by providing a catheter and a method of manufacturing the same wherein a length of flexible filament is wound in helical fashion about the lumen or passageway of the catheter.
In one embodiment, the flexible filament is wrapped about a tubular inner liner which defines the lumen, an outer jacket is formed over the filament, and the inner liner, the filament 2Q and the outer jacket are bonded together to form a unitary structure with torsional rigi~ity~ The pitch of the helically wound filament can be varied along the length of the linèr to vary the stiffness of the catheter.
Figure 1 is an elevational view, partly broken away, of one ~5 embodiment of a cardiovascular catheter incorporating the invention.
Figure ~ is an isometric view, somewhat schematic, of apparatus employed in one embodiment of a method of manufacturing the catheter of Figure 1.
As illustrated in Figure 1, the catheter (cles:igllatecl generally as 11) comprises a tubular i.nner liner 12 whi.ch defines all axially extending passageway or llmlen 13. l,iner 12 is -Fabricatecl o-f a flex;.ble, relatively slippery material such as polyte-trof]uoroe-thylerle (Teflon), with a relatively thin wall thiclcness, e.g. .0U3 inC]l.
An elongated -Filament 16 o:F flexible material is wrapped in helical fashion about the outer wall o:F liner 12 to give torsional rigidity to the catheter. In the embodiment illustrated, the filament is wrapped in two layers 17, 18 of opposite pitch, and the filament comprises a generally flat ribbon having a thickness on the order of .001 inch. In one presently preferred embodiment, the :Filament comprises a carbon -Filament having approxilllately 1,000 :incl:ividunl stral-cls -Formed into a bunclle o-f the cles.i.recl flat shape.
ln allotller, alld presently pre:Fcrred cmbodilllent, the f.i:lalllent comprises a 380 denier Kevlar (DuPont Trademarli) :fiber. This fiber is an aromatic polyamide material which has the advantage of being rela-tively flexible and less likely to break than a more brit-tle fiber.
}lowever, it will be understood that other :flexible fibers o:F high tensile strengt}- (i.e. 250,000 lbs./in.2!, such as boron filaments, can be used. Likewise, more than two layers of -Filament can be employ-ecl, if desirecl.
The pi-tc]-l o:F the filament windings can be variecl along the length of the liner to vary the stiffness of the catheter. In the embodiment of Figure 1, or example, the pitch is greater in regions 21, 22 toward the ends of the catheter than in central regi.on 23, and this catheter is stiffer in the central region than toward the ends.
- 3a -An outer jacket 26 o:E flex:ible ma-ter:ial :is formed over the outer layer 18 of Lilament 16 iand encases the :Filament. This jacket is fabricated oE a tllermop:Lastic materi.ll such as po:Ly-etllylene whic]l can be sterilized so as not to contamillate the body into which it is inserted. In one presently preferred embod:imen-t~
the outer jacket is fabricated oE a heat shrinkable tubing which is drawn tightly about the inner liner and the windings o:E
filament.
~4--Inner liner 12, filament 16 and outer jacket 26 are bonded together by suitable means such as epoxy to form a unitary structure. The unitary nature of the structure has been found to improve the torsional rigidity of the catheter and thereby facilitate turning and steering of the catheter during emplacement in the body.
A connecter 28, illustrated as a female Luer fitting, is attached to the inlet end of the catheter, and the distal end 29 can be formed with any desired bend, as in conventional guiding catheters.
Referring now to Figure 2, a preferred method of manufacturing the catheter is illustrated. Inner liner 12 is mounted on a wire-like mandrel 31 which extends axially through the opening in the tubing which forms the liner. To facilitate later removal, a lubricant such as silicon is applied to the mandrel before it is inserted into the tubing. The tubing is then temporarily affixed to the mandrel by suitable means, and in presently preferred embodiment the liner is fabricated of a heat shrinkable tubing which is heated and shrunk about the mandrel.
Mandrel 31 is mounted between the chucks 32, 33 of a winding machine 34 and drawn taut by suitable means such as a spring 36. A drive motor 37 is connected to chuck 32 to rotate the same about its axis, and chuck 33 is provided with a bearing
2~ which permits it to turn freely about its axis A spool 38 holding a filament 16 to be wrapped about liner 1~ is rotatively mounted on a carriage 39. This carriage is mounted on ways 41 for movement in the longitudinal direction between the chucks, and it is driven by a lead screw 42 and 3Q a reversible, variable speed drive motor 43.
' ?
Before the filament is wound on the liner, the surface of the liner is cleaned (e.g. by etching~, and a bonding agent such as epoxy is applied to the cleaned surface. The filament is affixed to the liner near one end thereof, and drlve motor 37 is energized to turn the mandrel about its axis and thereby wind the filament onto the liner. Drive motor 43 is also energi~ed to move carriage 39 toward the other end of the liner. ~s the carriage travels, the filament is wound onto the liner in helical fashion, with a pitch determined by the relative speeds of the two drive motors. With winding motor 37 turning at a relatively constant speed, the pitch of the winding is controlled by varying the speed of carriage motor 43.
For the catheter of Figure 1, inner liner 17 is wound as the carriage travels from one end of the liner to the other in one direction. When this layer is completed, the direction of carriage travel is reversed, and outer layer 18 is wound over the i.nner layer as the carriage returns to the start}ng position. In this embodiment, the speed of carriage motor 43 is increased for the central portions of the windings and decreased for the end portions, whereby the pitch of t~le windings is greater toward the end of the catheter.
When the winding is completed, additional bonding agent is applied to the filament, and outer jacket 26 is installed.
In one presently preferred embodiment, the outer jacket comprises a length of heat shrinkable tubing which is placed over the filament winding and the inner liner and heated to shrink about the filament and liner. Alternatively, the bonding agent can be applied to the filament before it is wrapped about the liner, in which case it is not necessary to make separate applications of the bonding agent to the liner and to the filament windings~
r- ~ ~
After the bonding agent has cured, the outer ~acket is ground to the desired outer diameter and the surface finish by a centerless grinding process. Thereafter, the mandre]
is removed from the central passageway, the catheter is cut to length, connector 28 is installed, and any desired bend can be formed in the distal end of the catheter.
Rather than using a separate inner liner, the filament can be impregnated with epoxy or another suitable material and wound directly on the winding mandrel. The outer jacket can then be formed over the filament as discussed above, following which the mandrel can be removed to form ~he central passageway or lumen.
The invention has a number of important features and advantages.
The helically wound filament and the unitary structure give the catheter a tortional rigidity which make it relatively eas~ to turn and steer the catheter as it is inserted into the body. The catheter has a relatively end wall and the stiffness of the catheter can be varied simply by varying the pitch of the helical filament windings. In addition, the catheter can be manufactured ~uickly and economically.
It is apparent from the foregoing that a new and improved catheter and method of manufacturing ~he same have been provided. While only certain presently preferred embodiments have been described in detail, as will be apparent to those familiar with the art, certain changes and modifications can be made without departing from the scope of the invention as def.ined by the followin~ claims.
' ?
Before the filament is wound on the liner, the surface of the liner is cleaned (e.g. by etching~, and a bonding agent such as epoxy is applied to the cleaned surface. The filament is affixed to the liner near one end thereof, and drlve motor 37 is energized to turn the mandrel about its axis and thereby wind the filament onto the liner. Drive motor 43 is also energi~ed to move carriage 39 toward the other end of the liner. ~s the carriage travels, the filament is wound onto the liner in helical fashion, with a pitch determined by the relative speeds of the two drive motors. With winding motor 37 turning at a relatively constant speed, the pitch of the winding is controlled by varying the speed of carriage motor 43.
For the catheter of Figure 1, inner liner 17 is wound as the carriage travels from one end of the liner to the other in one direction. When this layer is completed, the direction of carriage travel is reversed, and outer layer 18 is wound over the i.nner layer as the carriage returns to the start}ng position. In this embodiment, the speed of carriage motor 43 is increased for the central portions of the windings and decreased for the end portions, whereby the pitch of t~le windings is greater toward the end of the catheter.
When the winding is completed, additional bonding agent is applied to the filament, and outer jacket 26 is installed.
In one presently preferred embodiment, the outer jacket comprises a length of heat shrinkable tubing which is placed over the filament winding and the inner liner and heated to shrink about the filament and liner. Alternatively, the bonding agent can be applied to the filament before it is wrapped about the liner, in which case it is not necessary to make separate applications of the bonding agent to the liner and to the filament windings~
r- ~ ~
After the bonding agent has cured, the outer ~acket is ground to the desired outer diameter and the surface finish by a centerless grinding process. Thereafter, the mandre]
is removed from the central passageway, the catheter is cut to length, connector 28 is installed, and any desired bend can be formed in the distal end of the catheter.
Rather than using a separate inner liner, the filament can be impregnated with epoxy or another suitable material and wound directly on the winding mandrel. The outer jacket can then be formed over the filament as discussed above, following which the mandrel can be removed to form ~he central passageway or lumen.
The invention has a number of important features and advantages.
The helically wound filament and the unitary structure give the catheter a tortional rigidity which make it relatively eas~ to turn and steer the catheter as it is inserted into the body. The catheter has a relatively end wall and the stiffness of the catheter can be varied simply by varying the pitch of the helical filament windings. In addition, the catheter can be manufactured ~uickly and economically.
It is apparent from the foregoing that a new and improved catheter and method of manufacturing ~he same have been provided. While only certain presently preferred embodiments have been described in detail, as will be apparent to those familiar with the art, certain changes and modifications can be made without departing from the scope of the invention as def.ined by the followin~ claims.
Claims (3)
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. In a guiding catheter for insertion into a body passage of a patient, an elongate flexible tubular plastic member having a lumen extending therethrough, the member having a distal end adapted to be inserted into the body passage and a proximal end adapted to remain outside the body passage, a flat flexible ribbon wound helically in a first single layer in one direction onto the exterior of the tubular plastic member and a second single layer overlying the first layer and wound helically in an opposite direction onto the exterior of the tubular plastic member, each of the first and second layers having different pitches in different regions along the length of the tubular plastic member, means bonding the helically wound ribbon to the exterior surface of the plastic member, said first and second layers of ribbon providing torsional rigidity to the catheter facilitating steering and turning of the catheter in the body passage, and an outer flexible tube formed of a heat shrinkable material shrunk onto said elongate flexible tubular member with the ribbons bonded thereto to form a unitary assembly.
2. In a method for manufacturing a guiding catheter for insertion into a body passage of a patient, providing an elongate flexible tubular plastic member having a lumen extending therethrough, the member having a distal end adapted to be inserted into the body passage and a proximal end adapted to remain outside the body passage, providing a flat flexible ribbon, winding the flat flexible ribbon onto the outer surface of the tubular plastic member by winding the same helically in a first single layer in one direction onto the same and winding the same helically in an opposite direction in a second single layer overlying the first single layer, forming the helices of the flat flexible ribbon of different pitches in different regions along the length of the flexible tubular member, bonding the flat flexible ribbons to the flexible tubular plastic member, providing an outer tubing formed of a heat shrinkable material, mounting the tubing of heat shrinkable material.
over the tubular plastic member with the flat flexible ribbons wound thereon and applying heat to the outer tubing to cause it to shrink onto the tubular plastic member having the ribbon wrapped thereon to form the same into a unitary assembly.
over the tubular plastic member with the flat flexible ribbons wound thereon and applying heat to the outer tubing to cause it to shrink onto the tubular plastic member having the ribbon wrapped thereon to form the same into a unitary assembly.
3. A method as in Claim 2 together with the step of wrapping the ribbon about the tubular plastic member at different pitches in different regions along the length of the plastic tubular member, said flat flexible ribbons being wound so that they are tensioned so that the ribbons provide torsional rigidity to the catheter facilitating steering and turning of the catheter in the body passage.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US34358882A | 1982-01-28 | 1982-01-28 | |
| US343,588 | 1982-01-28 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1186582A true CA1186582A (en) | 1985-05-07 |
Family
ID=23346716
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000420455A Expired CA1186582A (en) | 1982-01-28 | 1983-01-28 | Cardiovascular catheter and method of manufacture |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1186582A (en) |
-
1983
- 1983-01-28 CA CA000420455A patent/CA1186582A/en not_active Expired
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