CA1150130A - Double lumen dilatation catheter - Google Patents
Double lumen dilatation catheterInfo
- Publication number
- CA1150130A CA1150130A CA000382533A CA382533A CA1150130A CA 1150130 A CA1150130 A CA 1150130A CA 000382533 A CA000382533 A CA 000382533A CA 382533 A CA382533 A CA 382533A CA 1150130 A CA1150130 A CA 1150130A
- Authority
- CA
- Canada
- Prior art keywords
- catheter
- fluid
- distal end
- port
- fitting
- 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
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
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
- A61B2090/3933—Liquid markers
-
- 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
- A61M2025/1065—Balloon catheters with special features or adapted for special applications having a balloon which is inversely attached to the shaft at the distal or proximal end
Abstract
IMPROVED DOUBLE LUMEN DILATATION CATHETER ABSTRACT OF THE DISCLOSURE A dilatation catheter (14, 16) is provided with a balloon element (18) which is invertable, evertable, and inflatable in its everted condition. The catheter is pro-vided with relatively moveable members akin to cylinder and piston elements including a port (40) which may be selective-ly closed off to prevent contrast injection material from being introduced into the blood vessel being treated and opened up for the introduction of contrast injection material into the blood vessel.
Description
IMPROVED DOUBLE LUMEN DILATATION CATHETER
RELATED APPLICATION
The subject catheter is an improvement upon the double lumen dilatation catheter constituting the third embodiment of the invention shown in United States Patent 4,271,839, granted June 9, 1981.
BACKGROUND OF THE INVENTION
The present invention relates to apparatus for use in dilating occluded blood vessels. The invention is parti-cularly concerned with such apparatus wherein dilatation is achieved through the means of a balloon element which is ` init.ially inverted within the distal end of a cathete.r and, in use, extruded through and expanded within the occlusion being treated. The invention is additionally concerned with ~uch apparatus having double lumen characteristics ~or the catheter to enable the taking of pressure measurements or the making of injections while the catheter remains within the . vessel being treated.
SUMMARY OF T~E INVENTION
In the improved doubl~ lumen catheter of the present invention, the invertable and evertable balloon element is : bulbous rather than annular in form and is physically attached only to the outer catheter. The inner catheter is thus made independent of the balloon element in the sense of physical attachment thereto. This means that the distal end of theinner catheter is not within the everted but non-inflated balloon element as the latter is moved for pre-inflation ~' 3~
positioning within the occlusion to be treated. Conse~uently, the diameter of the lumen of the inner catheter may be made almost as great as that of the outer catheter. This makes it feasible to efficiently employ the lumen of the inner catheter to inflate the balloon element as well as to inject radiopaque fluid into the vessel. The use of the lumen of the inner catheter for this two-fold purpose in turn enables simplifi-cation of the catheter by enabling the incorporation into it of a single syringe port for both balloon inflation and radio-paque fluid injection while enabling the elimination from thecatheter of the fluid reservoir which was employed as part of the double lumen catheter of the above-identified patent.
Other objects, features and advantages of the in-vention will be apparent from the following description taken in conjunction with the drawing forming part of this specifi-cation.
DESCRIPTION OF THE DRAWING
Fig. 1 is a view in perspective illustrating an occluded vessel in the process of being treated by the catheter of the invention.
Fign 2 is an elevational cross-sectional view illustrating the catheter with the balloon element in inflated condition.
Fig. 3 is a view similar to that of Fig. 2 but show-ing the catheter with its balloon element in deflated condi-tion and with the inner and outer catheter elements relatively positioned to enable the injection into the vessel of radio-paque material.
DESCRIPTION OF THE PREFE~RED EMBODIMENT
Fig. 1 illustrates a blood vessel 10 partially occluded by an occlusion 12. As sho~7n, the vessel is in -the for~ of an artery and the occlusion is what is commonly known as an arteriosclerotic plaque or atheroma. This is the type of adhering occlusion with which the su~ject catheter has primary application. It should be understood, however, that the invention is usable in treating other types of occluded vessels wherein dilatation is desirable. For example, the catheter of the invention may be used in treating occlusions resulting from fibromuscular dysplasia in veins.
The apparatus comprise~ a flexible but generally inelastic outer catheter 14 t a flexible but generally inelas-tic inner catheter 16, and a balloon element 18 attached to the distal end of outer catheter 14. As shown in Fig. 2, the balloon element 18 is adapted to have three positional condi-tions, that is, a normal storage condition in which it is inverted within the end of the outer cathe-ter 14, an everted but non-inflated condition to enable proper emplacement of the balloon element relative to -the occlusion, and an inflated con-dition to dilate the occlusion.
Outer catheter element 14 has its proximal end fixedly attached to sleeve 20 which is provided with lands 22 and 24. Inner catheter 16 has its proximal end fixedly attached to the distal end of a tube 26 forming part of a syringe fitting 28. The tube is provided with a distal flange 30 which is normally adapted to engage land 22 of sleeve 20 under the influence of compression spring 32 which is housed between sleeve 20 and tube 26 and between land 24 and flange 30. Lockiny means comprising pin 33 carried by sleeve 20 and bayonet slot 34 formed in the fitting 28 are provided to releasably loc~ sleeve 20 and tube 26 in the condition of Fig. 2 for normal use of the apparatus.
The distal end of inner catheter 16 is provided with a plurality of radially directed sealing ridges 36 which normally prevent the passage of pressurized fluid into the annular space 38 between catheter elements 14 and 16. The 3~
outer catheter element 14 is. ~rovided with'a fluid port 40.
The apparatus is typically used in the following manner. With locking means 33 and 34 mutually engaged and ~ith the balloon element 18 in inverted position within the end of catheter element 14~ the catheter device is introduced into the vessel 10 through an appropriate incision, not shown, and moved therealong until its leading end is disposed immediately adjacent the occlusion 12, as shown in Fig. 2.
Syringe 42 may then be attached to fitting 28 and operated 1~ to fill the interior passageways of elements 14 and 16 of the device and to evert the balloon element 18 to the dotted line position shown in Fig. 2. The subsequent addition of pres-surized fluid to the interior of the devlce with the syringe 42 causes the balloon element 18 to become~ inflated, as shown in solid outline in Fig. 2, to dilate occlusion 12.
After the occlusion has become compressed to the desi.red degree the ~alloon element 18 is deflated to the dotted line everted condition of Fig. 2 for removal of the device from the vessel or for movement of the device to anoth.er occlusion to be treated. Alternatively, the device may ~e'kept in place with the balloon e.lement in deflated condition for xadiopaque fluid injection. This is accom-plished b~ unlocking elements 33 and 34 and by backing the syringe fitting 28 away from sleeve 2Q so that the distal end of inner catheter element 16 has been moved sufficiently to uncover port 40. In this condition of the device radio-pa~ue fluid may be intxoduced through:the port into vessel 10.
After the xemoval-of th.e syringe.and the venting of the fluid from the dev.ice, the device is restored to its balloon-in~er.ted condition by moving the syringe fitting 28 a sufficient distance away from sleeve 2Q to cause cord 44, the'ends of which are fixedly attached to fitting 28 and to balloon element 18l to invert the 'balloon to the inverted dotted line condition of ~ig. 2. The syringe fitting 28 may then be re-attached to sleeve 20 by locking means 33 and 34.
3C~
The material and relative thicknesses of the balloon element 1~ are chosen so that expansion of the balloon element out of the end of the catheter takes place in anisotropic fashion, with the balloon element first everting out of the catheter in advance of substantial lateral expansion and then, after eversion, laterally expanding in response to the con-tinued application of fluid pressure intexnally of the cathe-ter. Once everted out oE the catheter, the balloon element is designed to laterally expand to an outside diameter equal to or greater than the I.D. of the non~occluded vessel being treated. Although such characteristics may be achieved through the employment of an elastomeric balloon element such as that above-described, it is anticipated that similar char-acteristics may be achieved by fabricating the balloon element of a folded generally inelastic flexible material, such as polyvinyl chloride, which is adapted to first evert to an extended conditi.on and`then unfold to a laterally expanded condition.
It .is to be pointed out that the subject catheter may be made in the form of a single lumen catheter incorporat-ing the usage of a piston which houses a syringe port for balloon inflation and reinversion.
RELATED APPLICATION
The subject catheter is an improvement upon the double lumen dilatation catheter constituting the third embodiment of the invention shown in United States Patent 4,271,839, granted June 9, 1981.
BACKGROUND OF THE INVENTION
The present invention relates to apparatus for use in dilating occluded blood vessels. The invention is parti-cularly concerned with such apparatus wherein dilatation is achieved through the means of a balloon element which is ` init.ially inverted within the distal end of a cathete.r and, in use, extruded through and expanded within the occlusion being treated. The invention is additionally concerned with ~uch apparatus having double lumen characteristics ~or the catheter to enable the taking of pressure measurements or the making of injections while the catheter remains within the . vessel being treated.
SUMMARY OF T~E INVENTION
In the improved doubl~ lumen catheter of the present invention, the invertable and evertable balloon element is : bulbous rather than annular in form and is physically attached only to the outer catheter. The inner catheter is thus made independent of the balloon element in the sense of physical attachment thereto. This means that the distal end of theinner catheter is not within the everted but non-inflated balloon element as the latter is moved for pre-inflation ~' 3~
positioning within the occlusion to be treated. Conse~uently, the diameter of the lumen of the inner catheter may be made almost as great as that of the outer catheter. This makes it feasible to efficiently employ the lumen of the inner catheter to inflate the balloon element as well as to inject radiopaque fluid into the vessel. The use of the lumen of the inner catheter for this two-fold purpose in turn enables simplifi-cation of the catheter by enabling the incorporation into it of a single syringe port for both balloon inflation and radio-paque fluid injection while enabling the elimination from thecatheter of the fluid reservoir which was employed as part of the double lumen catheter of the above-identified patent.
Other objects, features and advantages of the in-vention will be apparent from the following description taken in conjunction with the drawing forming part of this specifi-cation.
DESCRIPTION OF THE DRAWING
Fig. 1 is a view in perspective illustrating an occluded vessel in the process of being treated by the catheter of the invention.
Fign 2 is an elevational cross-sectional view illustrating the catheter with the balloon element in inflated condition.
Fig. 3 is a view similar to that of Fig. 2 but show-ing the catheter with its balloon element in deflated condi-tion and with the inner and outer catheter elements relatively positioned to enable the injection into the vessel of radio-paque material.
DESCRIPTION OF THE PREFE~RED EMBODIMENT
Fig. 1 illustrates a blood vessel 10 partially occluded by an occlusion 12. As sho~7n, the vessel is in -the for~ of an artery and the occlusion is what is commonly known as an arteriosclerotic plaque or atheroma. This is the type of adhering occlusion with which the su~ject catheter has primary application. It should be understood, however, that the invention is usable in treating other types of occluded vessels wherein dilatation is desirable. For example, the catheter of the invention may be used in treating occlusions resulting from fibromuscular dysplasia in veins.
The apparatus comprise~ a flexible but generally inelastic outer catheter 14 t a flexible but generally inelas-tic inner catheter 16, and a balloon element 18 attached to the distal end of outer catheter 14. As shown in Fig. 2, the balloon element 18 is adapted to have three positional condi-tions, that is, a normal storage condition in which it is inverted within the end of the outer cathe-ter 14, an everted but non-inflated condition to enable proper emplacement of the balloon element relative to -the occlusion, and an inflated con-dition to dilate the occlusion.
Outer catheter element 14 has its proximal end fixedly attached to sleeve 20 which is provided with lands 22 and 24. Inner catheter 16 has its proximal end fixedly attached to the distal end of a tube 26 forming part of a syringe fitting 28. The tube is provided with a distal flange 30 which is normally adapted to engage land 22 of sleeve 20 under the influence of compression spring 32 which is housed between sleeve 20 and tube 26 and between land 24 and flange 30. Lockiny means comprising pin 33 carried by sleeve 20 and bayonet slot 34 formed in the fitting 28 are provided to releasably loc~ sleeve 20 and tube 26 in the condition of Fig. 2 for normal use of the apparatus.
The distal end of inner catheter 16 is provided with a plurality of radially directed sealing ridges 36 which normally prevent the passage of pressurized fluid into the annular space 38 between catheter elements 14 and 16. The 3~
outer catheter element 14 is. ~rovided with'a fluid port 40.
The apparatus is typically used in the following manner. With locking means 33 and 34 mutually engaged and ~ith the balloon element 18 in inverted position within the end of catheter element 14~ the catheter device is introduced into the vessel 10 through an appropriate incision, not shown, and moved therealong until its leading end is disposed immediately adjacent the occlusion 12, as shown in Fig. 2.
Syringe 42 may then be attached to fitting 28 and operated 1~ to fill the interior passageways of elements 14 and 16 of the device and to evert the balloon element 18 to the dotted line position shown in Fig. 2. The subsequent addition of pres-surized fluid to the interior of the devlce with the syringe 42 causes the balloon element 18 to become~ inflated, as shown in solid outline in Fig. 2, to dilate occlusion 12.
After the occlusion has become compressed to the desi.red degree the ~alloon element 18 is deflated to the dotted line everted condition of Fig. 2 for removal of the device from the vessel or for movement of the device to anoth.er occlusion to be treated. Alternatively, the device may ~e'kept in place with the balloon e.lement in deflated condition for xadiopaque fluid injection. This is accom-plished b~ unlocking elements 33 and 34 and by backing the syringe fitting 28 away from sleeve 2Q so that the distal end of inner catheter element 16 has been moved sufficiently to uncover port 40. In this condition of the device radio-pa~ue fluid may be intxoduced through:the port into vessel 10.
After the xemoval-of th.e syringe.and the venting of the fluid from the dev.ice, the device is restored to its balloon-in~er.ted condition by moving the syringe fitting 28 a sufficient distance away from sleeve 2Q to cause cord 44, the'ends of which are fixedly attached to fitting 28 and to balloon element 18l to invert the 'balloon to the inverted dotted line condition of ~ig. 2. The syringe fitting 28 may then be re-attached to sleeve 20 by locking means 33 and 34.
3C~
The material and relative thicknesses of the balloon element 1~ are chosen so that expansion of the balloon element out of the end of the catheter takes place in anisotropic fashion, with the balloon element first everting out of the catheter in advance of substantial lateral expansion and then, after eversion, laterally expanding in response to the con-tinued application of fluid pressure intexnally of the cathe-ter. Once everted out oE the catheter, the balloon element is designed to laterally expand to an outside diameter equal to or greater than the I.D. of the non~occluded vessel being treated. Although such characteristics may be achieved through the employment of an elastomeric balloon element such as that above-described, it is anticipated that similar char-acteristics may be achieved by fabricating the balloon element of a folded generally inelastic flexible material, such as polyvinyl chloride, which is adapted to first evert to an extended conditi.on and`then unfold to a laterally expanded condition.
It .is to be pointed out that the subject catheter may be made in the form of a single lumen catheter incorporat-ing the usage of a piston which houses a syringe port for balloon inflation and reinversion.
Claims (5)
1. Apparatus for dilating a partially occluded section of a blood vessel and for introducing a radiopaque fluid into the vessel comprising an elongated flexible catheter, balloon means attached to the distal end of said catheter, a fluid port in said catheter through which radio-paque fluid may be introduced into said vessel, means defin-ing a fluid passageway within said catheter whereby fluid may be introduced into said balloon means, and slide valve means disposed in said catheter and selectively movable relative to said port whereby said port can be brought into communication with said fluid passageway and out of communication therewith.
2. Apparatus for dilating a partially occluded section of a blood vessel and for introducing a radiopaque fluid into the vessel comprising an elongated flexible cathe-ter, a fluid port in said catheter, a tubular member slidably disposed in said catheter, said member having an open distal end and having radially directed sealing means carried adjacent said distal end disposed in sealing engagement with the inner surface of said catheter, means associated with said member for introducing fluid into said catheter and into said balloon means through the open distal end of said tubu-lar member, and means for moving said tubular member within said catheter to selectively close off communication between said port and the open distal end of said tubular member and to bring said port and said open distal end into communication with each other.
3. The apparatus of Claim 2, said tubular member having an open proximal end attached to a syringe fitting, and means mounting the proximal end of said catheter on said fit-ting so as to allow limited reciprocal movement of said fit-ting and tubular member relative to said catheter.
4. The apparatus of Claim 3, said mounting means comprising inner and outer annular members, the inner member interconnecting said fitting and said tubular member, the outer member being connected to said catheter, radially projecting flanges on said annular members to maintain said annular members in connected relation while permitting limited sliding movement of one with respect to the other, spring means interengaging said flanges to yieldingly urge said fitting toward said catheter, and complemental locking means to releasably secure said fitting and catheter against move-ment relative to each other.
5. The apparatus of Claim 4, further comprising cord means interconnecting said fitting and the distal end of said balloon means, whereby the movement of said fitting away from said catheter to a first position brings said port and the open distal end of said tubular member into communication with each other without causing said cord means to retract said balloon means and whereby the further movement of said fitting away from said catheter to a second position causes said cord means to retract said balloon means to an inverted position within said catheter.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US176,009 | 1980-08-07 | ||
| US06/176,009 US4318410A (en) | 1980-08-07 | 1980-08-07 | Double lumen dilatation catheter |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1150130A true CA1150130A (en) | 1983-07-19 |
Family
ID=22642595
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000382533A Expired CA1150130A (en) | 1980-08-07 | 1981-07-24 | Double lumen dilatation catheter |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US4318410A (en) |
| EP (1) | EP0057689B1 (en) |
| JP (1) | JPS612382B2 (en) |
| CA (1) | CA1150130A (en) |
| DE (1) | DE3176419D1 (en) |
| WO (1) | WO1982000408A1 (en) |
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| TWI633900B (en) * | 2014-03-31 | 2018-09-01 | 日商東麗股份有限公司 | Ablation catheter with balloon |
| US10086213B2 (en) | 2015-04-23 | 2018-10-02 | Mark A. D'Andrea | Mobile gynecological balloon devices and methods |
| GB2548086B (en) * | 2016-03-01 | 2020-01-29 | Strait Access Tech Holdings Pty Ltd | An inflatable insertion device for percutaneous insertion |
| US11369400B2 (en) | 2019-03-20 | 2022-06-28 | Covidien Lp | Balloon dissector |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE106568C (en) * | ||||
| DE169549C (en) * | 1905-03-18 | |||
| US805851A (en) * | 1905-05-16 | 1905-11-28 | Natusius Josef Goldfarb | Medicinal injector. |
| GB380186A (en) * | 1931-07-02 | 1932-09-15 | Edmund William Hart | Improvements in pocket devices for the treatment of insect stings and the like |
| DE1117258B (en) * | 1959-10-19 | 1961-11-16 | Medizintechnik Leipzig Veb | Sample excision device |
| US3168092A (en) * | 1961-06-15 | 1965-02-02 | Silverman Daniel | Medical probing instrument having flexible, extrudable tubing adapted to be extraverted under pressure into a body cavity |
| US3435826A (en) * | 1964-05-27 | 1969-04-01 | Edwards Lab Inc | Embolectomy catheter |
| IL23743A (en) * | 1965-06-16 | 1969-05-28 | Simkin A | Extendible probes |
| US3467101A (en) * | 1965-09-30 | 1969-09-16 | Edwards Lab Inc | Balloon catheter |
| US3448739A (en) * | 1966-08-22 | 1969-06-10 | Edwards Lab Inc | Double lumen diagnostic balloon catheter |
| US3467102A (en) * | 1967-04-18 | 1969-09-16 | Edwards Lab Inc | Leader type catheter |
| US3593713A (en) * | 1968-07-12 | 1971-07-20 | Stanley A Bogoff | Catheter combination |
| US3583391A (en) * | 1968-11-21 | 1971-06-08 | American Hospital Supply Corp | Medical instrument with outrolling catheter |
| US3866599A (en) * | 1972-01-21 | 1975-02-18 | Univ Washington | Fiberoptic catheter |
| US3911927A (en) * | 1974-04-17 | 1975-10-14 | Princeton Biomedix | Eversible catheter |
| US4122591A (en) * | 1974-05-02 | 1978-10-31 | Byk Gulden Lomberg Chemische Fabrik - Gmbh | Catheter |
| US3923065A (en) * | 1974-09-09 | 1975-12-02 | Jerome Nozick | Embolectomy catheter |
| US4102342A (en) * | 1975-12-29 | 1978-07-25 | Taichiro Akiyama | Valved device |
| US4077610A (en) * | 1976-01-06 | 1978-03-07 | Senichi Masuda | Method and apparatus for passing an article through an interior of a pipe |
| FR2340078A1 (en) * | 1976-02-03 | 1977-09-02 | Testart Jacques | Surgical probe with rigid central tube - has head sliding on tubes and fixed to outer elastic sheath |
| US4085757A (en) * | 1976-04-29 | 1978-04-25 | P Pevsner | Miniature balloon catheter method and apparatus |
| US4109659A (en) * | 1976-07-19 | 1978-08-29 | Mallinckrodt, Inc. | Evagination catheters |
| CH616337A5 (en) * | 1977-10-21 | 1980-03-31 | Schneider Medintag Ag | |
| FR2450113B2 (en) * | 1978-05-10 | 1983-06-17 | Agronomique Inst Nat Rech | CERVICAL EMBRYO COLLECTING DEVICE |
-
1980
- 1980-08-07 US US06/176,009 patent/US4318410A/en not_active Expired - Lifetime
-
1981
- 1981-07-24 CA CA000382533A patent/CA1150130A/en not_active Expired
- 1981-07-27 JP JP56502713A patent/JPS612382B2/ja not_active Expired
- 1981-07-27 EP EP81902180A patent/EP0057689B1/en not_active Expired
- 1981-07-27 WO PCT/US1981/001004 patent/WO1982000408A1/en active IP Right Grant
- 1981-07-27 DE DE8181902180T patent/DE3176419D1/en not_active Expired
Also Published As
| Publication number | Publication date |
|---|---|
| EP0057689A4 (en) | 1984-09-05 |
| US4318410A (en) | 1982-03-09 |
| EP0057689A1 (en) | 1982-08-18 |
| JPS57501166A (en) | 1982-07-08 |
| WO1982000408A1 (en) | 1982-02-18 |
| JPS612382B2 (en) | 1986-01-24 |
| DE3176419D1 (en) | 1987-10-15 |
| EP0057689B1 (en) | 1987-09-09 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEX | Expiry | ||
| MKEX | Expiry |
Effective date: 20000719 |