CA2078201C - Soft tip angioplasty balloon catheter - Google Patents

Soft tip angioplasty balloon catheter Download PDF

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Publication number
CA2078201C
CA2078201C CA002078201A CA2078201A CA2078201C CA 2078201 C CA2078201 C CA 2078201C CA 002078201 A CA002078201 A CA 002078201A CA 2078201 A CA2078201 A CA 2078201A CA 2078201 C CA2078201 C CA 2078201C
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CA
Canada
Prior art keywords
tip
catheter
balloon
distal end
soft
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 - Lifetime
Application number
CA002078201A
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French (fr)
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CA2078201A1 (en
Inventor
Fred T. Parker
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Cook Inc
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Cook Inc
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Filing date
Publication date
Priority claimed from US07/725,754 external-priority patent/US5221270A/en
Application filed by Cook Inc filed Critical Cook Inc
Publication of CA2078201A1 publication Critical patent/CA2078201A1/en
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Publication of CA2078201C publication Critical patent/CA2078201C/en
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Expired - Lifetime legal-status Critical Current

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Abstract

A soft tip angioplasty balloon catheter having mating internal and external tapers for banding the soft tip to the main portion of the catheter. The main portion includes a dual lumen tube and a single lumen tube extending from the distal end thereof. A circularly shaped passageway for insertion over a wire guide extends longitudinally through the entire main portion and soft tip of the catheter. A
second, crescent or quarter-moon shaped passageway extends through the dual lumen tube and communicates with the interior of an uninflated angioplasty balloon for the inflation thereof. The balloon is positioned and stored around the smaller diameter single lumen tube. The angioplasty balloon is attached about the distal end of the dual lumen tube and the proximal end of the soft tubular tip. The distal end of the balloon is positioned in an annular recess about the proximal end of the soft tip with an outside diameter that approximates the maximum outside diameter of the catheter about the main portion. Tungsten ring markets are positioned around the single lumen tube to indicate the position of the angioplasty balloon when in a coronary vessel. The distal end of the soft tip is also externally tapered to minimize trauma to a coronary vessel wall. The tubular tip comprises a material having a durometer softer than that of the main portion for further minimizing trauma to a coronary vessel wall.

Description

SOFT TIP ANGIOPLASTY BALLOON CATHETER
Technical Field This invEmtion rel.ate.7 general_Ly to angioplasty balloon catheters and, an part.:lcular, to an angioplasty balloon catheter having a soft tip.
Background. of the Invention Angioplasty balloon cath~=_ters are commonly introduced through a guiding c.:~at:.heter to a treatrren:. site in a coronary vessel. To move an angioplasty balloon catheter J.0 safely into the del:i.cat.e cororla:ey VE_:~sels, the angioplasty balloon catheter must~ have a soft distal tip. The soft distal tip minimizes true risk of causing trauma to a vessel, freeing placLue from a vessel wall, puncturing the vessel, or creating embolism in the bloodstream. In addition, a soft di=;ta.1 yip tracks. over a wire guide much easier than a catheter having ;. F ip ~,~ith tre same or higher durometer rnaicerial than that oj: the main body.
Several nonanalogo~~s catheters include distal ends with a sof ter durometer than the durorneter of the proximal or main bocly portion c:~f the c~~thet:.er. ~Jne thin-walled catheter used, for example, as an intravascular or guiding catheter or a s:r:~ath has a tabu:Lar body portion and a tip portion . 'I'he tubu_ar k.~ody portion includes a rigid inner sheat}u and a t_lexibl;= outer sheath. The
2'.i flexible outer srie,-~th ext:end~: beyond the distal end of the inner shc-ath for t_ormlng the t=ip portion. A
problem with thi:> catheter i.s that the tip portion comprises the same dura;meter materiel as the outer Parker 4 layer of the tubular body portion. As a result, the flexibility and softness of the tip portion is limited.
Another problem with this catheter is the abrupt change in durometer between the tubular body and the tip portion. As a result, the base of the tip portion is unsupported and prone to being damaged.
One angiographic catheter comprises an inner tube of polyamide externally tapered about the distal end and jacketed by a urethane material. The urethane material is internally tapered to match the externally tapered inner tube and extends beyond the distal end of the inner tube to form a flexible tip. Although well-suited as an angiographic catheter to withstand high burst pressures of injected contrast medium, the thickness of the catheter walls severely limits the use of 'this catheter as an angioplasty balloon catheter. The thick catheter walls result in a large outside diameter. The outside diameter of an angioplasty balloon catheter is preferably as small as possible for insertion through tortuous coronary vessels and delivering angioplasty treatment thereto.
One guiding catheter includes a wire--braided polytetrafluoroethylene inner tube with a polyurethane jacket epoxied thereto that abruptly terminates near the distal end of the inner tube. A metal radiopaque marker and a soft polyurethane tip are positioned around the distal end of the polytetrafluoroethylene inner tube and abut the abrupt, step-like shoulder at the distal end of the polyurethane jacket. The polyurethane tip is thermally bonded to the polyurethane jacket. A problem with this design is that the contact surface area between the abrupt, step-like shoulder of the polyurethane jacket and the proximal end of the polyurethane tip is limited, thereby significantly increasing the likelihood that the tip will be dislodged or separated from the step-like shoulder of the jacket. The metal radiopaque marker positioned between the jacket and tip further reduces the contact surface area Farker 4 therebetween and increases the likelihood of jacket and tip separation.
Summary of the Invention The foregoing problems are solved and a technical advance is achieved in an illustrative soft tip angioplasty balloon catheter having a main tubular portion and a softer material tubular tip with respective mating external and internal tapers for advantageously increasing the bonding area and minimizing the likelihood of separation therebetween. Furthermore, the tapers provide a gradual change in durometer between the soft tip and main tubular portion. By way of example, the main tubular portion of the catheter comprises a radiopaque vinyl tube. The tip of the catheter comprises a soft vinyl material having a durometer softer than the durometer of the main tubular portion for minimizing trauma to vessel walls. An angioplasty balloon is attached about the proximal end of the tubular tip and also about the main portion proximally from the tip. The uninflated balloon is positioned and stored around a reduced diameter distal portion of the main tubular portion.
The soft tubular tip has distal and proximal ends and a passageway extending longitudinally therein and communicating with the passageway of the main tubular portion for insertion of the catheter over a wire guide.
The tubular tip includes an external taper about the distal end thereof For advantageously presenting a reduced diameter, soft, blunt surface to vessel walls. The external taper of the soft tip has a maximum outside diameter approximating the outside diameter of the main tubular portion with the uninflated balloon positioned around the reduced diameter distal portion. The external tapers of the tubular tip and the main portion each extend longitudinally in a range of, for example, 3 to 5 mm. The tapers overlap in a range of, for example, 1.5 to 2.5 mm.
The distal end of the balloon is positioned in and
3 Par)cer 4 .
attached to an annular recess at the proximal end of the tubular tip. The proximal end of the balloon is attached proximally from the tip on the outer proximal surface of 'the main tubular portion. The maximum outside diameter of the tubular tip and distal end of the balloon approximate the outside diameter of the main tubular portion with the uninflated balloon positioned therearound.
The balloon further includes a mid-section stored around a reduced diameter distal portion of the main tubular portion and expandable to a fourth outside diameter for dilating a vessel during an angioplasty procedure. The balloon comprises, for example, polyethylene terephalate.
The catheter further includes a second passageway extending in the main portion and communicating with the interior of the balloon for inflating the balloon to an expanded state.
The main tubular portion advantageously includes a dual lumen proximal portion tube and a single lumen distal portion tube extending distally therefrom. The single lumen tube is smaller in diameter than the dual lumen tube, which allows for storage of the uninflated balloon therearound.
The diameter of the stored balloon is advantageously no greater than the dual lumen tube or the soft catheter tip.
The second lumen of the dual lumen tube communicates with the interior of the balloon for inflation of the balloon.
Brief Description of the Drawina FIG. 1 depicts a partially sectioned side view of an illustrative soft tip angioplasty balloon catheter of the present invention; and FIG. 2 depicts a cross-sectional view of the proximal portion tube of the catheter of FIG. 1.
Detailed Description FIG. 1 depicts a partially sectioned side view of an illustrative soft tip angioplasty balloon catheter 3.0 having
4 ~~"~8~~~.
Parker 4 main tubular portion 11 and soft 'tubular tip 12 interconnected by thermal bond 15. Distal end 19 of the main portion includes an external taper 13, and proximal end 30 of 'the soft tip includes mating internal taper 14. The mating external and internal tapers increase the contact surface area between the main portion and soft tip, thereby strengthening the thermal bond and preventing separation of the main portion and soft tip. The bonded tapers also provide a gradual change in the durometer of the catheter between the main portion and soft tip. Soft tip 12 comprises a soft vinyl material with a durometer softer than the materials of main portion 11. Main portian 11 comprises a harder durometer, vinyl radiopaque material and advances the catheter through the tortuous coronary vessels while the softer durometer tip minimizes vessel wall trauma. The soft tip also increases trackability of the catheter over a wire guide.
The catheter also includes balloon 16 (depicted in an inflated state) having a distal end 17 attached about proximal end 30 of the soft tip in annular recess 22.
Distal end 17 of the balloon is positioned in annular recess 22 and attached thereto using, for example, a medical grade adhesive 23 such as Loctite No. 454 adhesive. Proximal end 18 of the balloon is attached circumferentially around outer surface 32 of the main portion proximally from the soft tip using, again, medical grade adhesive 23. This normally presents the maximum outside diameter of the main portion with balloon 16 uninflated. The maximum outside diameter of the soft tip with distal end 17 of the balloon attached thereto approximates the maximum outside diameter of the main portion with the uninflated balloon positioned therearound. The approximate diameters provide fox ready and atraumatic insertion of the catheter through a guiding catheter and into a coronary vessel.
Main, tubular portion 11 of the catheter includes a dual lumen proximal portion tube 33 and a single lumen distal
5 Parker 4 portion tube 34. The dual lumen proximal portion tube comprises a vinyl radiopaque material haring a circularly _ shaped passageway 21 and a second, crescent or quarter-moon shaped passageway 24, as depicted in FIG 2. The vinyl radiopaque material of proximal portion tube 33 has a durometer of 97 on the Shore A scale. The single lumen distal portion tube also comprises a vinyl radiopaque material having a somewhat harder durometer than the proximal portion tube, such as 51 on the Shore D scale.
Distal end 35 of proximal portion tube 33 is counterbored and internally tapered, and the outside diameter of proximal end 36 of distal portion tube 34 is reduced and externally tapered as shown. The reduced diameter and externally tapered proximal end of the single lumen tube is inserted into the circular passageway of counterbored and internally tapered distal end 35 and heated to form thermal bond 37.
Main tubular portion 11 is approximately 130 cm in length with circularly shaped passageway 21 extending longitudinally therethrough. External taper 13 about distal end 19 extends longitudinally for a predetermined length in a range of 3 to 5 mm. Single lumen distal portion tube 34 comprises a 52 mm length of 5 French tube with an inside diameter of approximately .043'° and an outside diameter of approximately .066".
Main tubular portion 11 further includes a 100 cm length of 5.3 French dual lumen proximal portion tube 33 with circularly shaped passageway 21 and crescent shaped passageway 24 extending longitudinally therethrough between proximal end 20 and distal end 35. As previously described, circularly shaped passageway 21 extends entirely through main tubular portion 11 for insertion over a wire guide, whereas crescent shaped passageway 24 extends only through the proximal portion tube to balloon interior 25 for inflating the uninflated balloon with fluid during an angioplasty procedure. When the balloon is inflated, mid-section 26 of the balloon expands for dilating a stenosis in
6 Parker 4 4 , a coronary vessel.
Balloon 16 comprises, for example, polyethylene terephalate material and is approximately 40 mm in length with reduced diameter distal and proximal ends 17 and 18, each approximately 4 mm in length. The distal and proximal balloon ends are attached respectively to proximal end 30 of the soft tip and distal end 35 of the proximal portion tube for a length of approximately 2 mm by commercially available, medical grade adhesive 23. A vinyl dispersion coating (not shown) is placed over the proximal balloon end where it is bonded to the main portion for further affixing the balloon to the main portion and for providing a smooth outer surface at the bond. Balloon markers 27 and 28 are positioned around the main portion under the balloon near the distal and proximal balloon ends, respectively, for providing radiopaque visualization of each end of the mid-section of the balloon. The markers comprise, for example, tungsten rings.
Soft tubular 'tip 12 comprises a soft vinyl material having a durometer of approximately 60 on the Shore A scale and includes distal end 29, proximal end 30, and passageway 31 extending longitudinally therethrough. Soft tip passageway 31 communicates directly with main tubular portion passageway 21. The soft tubular tip is approximately 6 mm in length and has a minimum inner diameter of approximately .037'° and a maximum outer diameter of approximately .080". The soft tubular tip further includes external taper 38 about distal end 29 for presenting a reduced diameter, blunt, atraumatic surface to vessel walls. External taper 38 extends for a predetermined length in a range of 3 to 5 mm and overlaps external taper 13 of the main portion for a predetermined length in a range of 1.5 to 2.5 mm. Annular recess 22 positioned about proximal end 30 of the soft tubular tip extends longitudinally for approximately 2 mm for positioning and attaching distal and 17 of the balloon thereto.
7 Parker 4 Proximal end 20 of the main tubular portion is fixedly attached in a well-~;nown manner to single lumen extension tubes 39 and 40 at manifold cover 41 by thermal bonding and an application of a medical grade adhesive. Extension tube 39 comprises, for example, vinyl nonradiopaque tubing approximately 12.5 cm in length and has well-known female Luer lock connector 42, fixedly attached about the proximal end thereof using medical grade adhesive. A commercially available one-way stopcock 43 is attached to the female Luer lock connector for controlling the injection and withdrawal of fluid to the interior of the balloon. Extension tube 40 comprises, for example, vinyl nonradiopaque tubing approximately 7 cm in length and has well-known female Luer lock connector 44 fixedly attached about the proximal end thereof using a medical grade adhesive.
It is to be understood 'that the above-described soft tip angioplasty balloon catheter is merely an illustrative embodiment of the principles of this invention and that other embodiments may be devised by those skilled in the art without departing from the spirit and scope of this invention. The above-described angioplasty balloon catheter has been described for use in vessels of the vascular system and, in particular, for use :in the coronary vessels.
However, the dimensions of the above-described catheter are more particularly suited for use in the renal and peripheral vasculature. Another contemplated use of this angioplasty catheter is in the iliac and femoral vessels. Various other sizes of the above-described catheter are contemplated for use in other vessels, such as the coronary and cerebral vessels. It is contemplated that various other materials of comparable durometers may be utilized for the main portion or soft tip. In summary, the soft tip thermally bonded to the main portion by respective internal and external tapers presents a soft, atraumatic surface to delicate coronary vessels.
8

Claims (6)

Claims
1. A soft tip angioplasty balloon catheter comprising a main tubular portion with a passageway extending longitudinally therethrough, the main portion comprising a first material having a first durometer, a tubular tip comprising a second material having a second durometer softer than the first material, said tip having a distal end and a proximal end with a passageway extending therebetween and in communication with the first mentioned passageway, the main portion and the soft tip having overlapping sections which are bonded together, the soft tip having a section extending distally beyond the distal end of the said tubular portion, an inflatable balloon with the distal end of the balloon attached about or in the region of the proximal end of the soft tip, and with the proximal end of the balloon attached about the said main portion, characterized in that the main portion and the soft tip have cooperating tapered surfaces bonded together to form the said overlapping sections, in that the cooperating tapered surfaces extend beyond the distal end of the balloon, and in that the distal end of the tubular tip has an externally tapered section.
2. The catheter of claim 1, characterized in that the said externally tapered section partially overlaps the said cooperating tapered surfaces.
3. The catheter of claim 1, or 2, characterized in that an annular recess is formed at the proximal end of the soft tip for accommodating the distal end of the balloon, with or without adhesive.
4. The catheter of claim 1, 2, or 3, characterized in that the balloon comprises polyethylene terephthalate, and/or the main portion includes a vinyl radiopaque tube, and/or the tubular tip comprises soft vinyl material.
5. The catheter of claim 1, 2, 3, or 4, characterized in that the main portion is externally tapered about the distal end thereof, and in that the soft tip is internally tapered from the proximal end thereof.
6. The catheter of claim 1, 2, 3, 4, or 5, characterized in that the soft tip has a maximum. outside diameter adjacent the proximal end thereof, and in that an outer diameter of the tubular portion approximates said maximum diameter.
CA002078201A 1991-06-28 1992-09-14 Soft tip angioplasty balloon catheter Expired - Lifetime CA2078201C (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US07/725,754 US5221270A (en) 1991-06-28 1991-06-28 Soft tip guiding catheter
US725,754 1991-06-28
US76072391A 1991-09-16 1991-09-16
US760,723 1991-09-16

Publications (2)

Publication Number Publication Date
CA2078201A1 CA2078201A1 (en) 1992-12-29
CA2078201C true CA2078201C (en) 2004-01-27

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CA002078201A Expired - Lifetime CA2078201C (en) 1991-06-28 1992-09-14 Soft tip angioplasty balloon catheter

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Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6659977B2 (en) 1993-10-27 2003-12-09 Schneider (Europe) A.G. Multilayer interventional catheter
US5961765A (en) 1994-09-20 1999-10-05 Schneider (Europe) A. G. Method of making a catheter
US6165166A (en) 1997-04-25 2000-12-26 Schneider (Usa) Inc. Trilayer, extruded medical tubing and medical devices incorporating such tubing
US20020007145A1 (en) 1998-10-23 2002-01-17 Timothy Stivland Catheter having improved bonding region
US8216498B2 (en) 2008-09-10 2012-07-10 Boston Scientific Scimed, Inc. Catheter having a coextruded fluoropolymer layer

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