Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/32—Surgical cutting instruments
  • A61B17/3205—Excision instruments
  • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
  • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
• • 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
  • A61M25/1027—Making of balloon catheters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M25/104—Balloon catheters used for angioplasty
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
  • A61B2017/22061—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation for spreading elements apart
• • 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
  • A61M25/1027—Making of balloon catheters
  • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
  • A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• • 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
  • A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• • 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
  • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• • 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
  • A61M25/1027—Making of balloon catheters
  • A61M25/1038—Wrapping or folding devices for use with balloon catheters

Definitions

• the present invention relates generally to balloon catheters, and more particularly, to a balloon catheter assembly for use in angioplasty procedures wherein the balloon portion of the assembly is provided with plaque-cutting edges disposed along the outer surface of the balloon.
• Coronary artery disease, or atherosclerosis results in restrictions in the flow of blood to the heart and other areas of the circulatory system. Such restrictions occur primarily as a result of the formation of obstructions, such as plaque, in one or more of the blood vessels of the patient.
• PTCA percutaneous transluminal coronary angioplasty
• balloon angioplasty Balloon angioplasty is utilized to open arteries whose lumens have been restricted due to this build-up of plaque, a condition known as stenosis.
• an incision is made in a specific area of the patient's body to gain access to an artery, such as the femoral artery.
• a balloon-tipped catheter is inserted into the artery and threaded through the artery to the site of the blockage.
• the balloon is inflated.
• the inflated balloon pushes the plaque back against the artery wall, thereby removing the restriction and restoring the pathway for blood flow through the vessel.
• the balloon may be deflated and re-inflated one or more additional times.
• a stent may be inserted at the position of the blockage to prop the artery open.
• the plaque deposit may have hardened or become calcified to such an extent that it does not easily yield to the balloon.
• balloon angioplasty must often be carried out at higher pressures to crack the calcified plaque.
• the physician must exercise a high amount of care to avoid rupturing the balloon and/or the artery at the site of the plaque deposit.
• the invention comprises a balloon catheter assembly for use in breaking down restrictions in a blood vessel.
• the assembly comprises an elongated catheter shaft having a proximal portion and a distal portion, and an inflatable balloon secured to the shaft distal portion.
• a plurality of cutters is disposed along an outer surface of the balloon. The cutters are shielded by folds of the balloon when the balloon is in an uninflated condition, and are arranged and configured to facilitate breakdown of a vascular restriction when the balloon is in an inflated condition.
• the invention comprises a method for breaking down a restriction in a blood vessel of a patient.
• a balloon catheter assembly is provided for insertion into the vessel.
• the balloon catheter assembly comprises an elongate catheter shaft and an inflatable balloon secured to a distal portion of the catheter shaft.
• the balloon has a plurality of cutters fixedly disposed in respective generally parallel longitudinal rows along an outer surface thereof. The cutters are shielded by folds of the balloon when the balloon is in an uninflated condition, and are arranged and configured to facilitate a breakdown of the restriction when the balloon is in an inflated condition.
• the distal end of the balloon catheter assembly is inserted into the vessel, and advanced in the vessel with the balloon in an uninflated condition until the uninflated balloon reaches the restriction.
• the balloon is then inflated such that the cutters penetrate the restriction.
• the balloon is then deflated.
• the balloon may be reinflated and deflated additional times if desired.
• FIG. 1 is a perspective view of a distal portion of a balloon catheter according to an embodiment of the present invention, showing the balloon in an inflated condition;
• FIG. 2 is a side view of the balloon catheter portion shown in Fig. 1 ;
• Fig. 3 is a distal end view of the catheter of Fig. 2 taken from line 3-3 of
• Fig. 4 is a side view of the balloon catheter portion of Fig. 1, showing the balloon in the uninflated condition;
• Fig. 5 is a sectional view of the catheter portion and uninflated balloon of Fig. 4, taken from line 5-5 of Fig. 4;
• Fig. 6 is a sectional view of a cutter for the balloon catheter, taken along line 6-6 of Fig. 2; and [0016] Fig. 7 is a perspective view of one form of a cutter* shown removed from the balloon.
• proximal and distal will be used to describe the opposing axial ends of the balloon catheter assembly, as well as the axial ends of various component features.
• proximal is used in its conventional sense to refer to the end of the assembly, or component thereof, that is closest to the operator during use of the assembly.
• distal is used in its conventional sense to refer to the end of the assembly, or component thereof, that is initially inserted into the patient, or that is closest to the patient.
• Fig. 1 illustrates a perspective view of the distal portion of a balloon catheter assembly 10 according to an embodiment of the present invention.
• Fig. 2 illustrates a side view of the balloon catheter assembly of Fig. 1, and Fig.
• Balloon 14 comprises a generally cylindrical outer main body 16, and includes a proximal taper 18 and a distal taper 20. Proximal taper 18 tapers to proximal balloon end portion 19, and distal taper 20 tapers to distal balloon end portion 21.
• Respective proximal and distal end portions 19, 21 are sealingly engaged with catheter shaft 12 to provide a fluidtight connection between the catheter shaft and the respective proximal and distal ends of the balloon in well- known fashion.
• Balloon may be inflated in conventional fashion, such as by passing an inflation fluid from an inflation source through a lumen in catheter shaft 12, and into the interior space of the balloon through one or more ports in the shaft.
• balloon 14 is a non-compliant balloon of the type commonly used in balloon angioplasty procedures.
• Non-compliant balloons are well-known for their ability to maintain their inflated diameter under high pressure conditions of the type that may be encountered during a balloon angioplasty procedure. Although non-compliant balloons are preferred for this reason, those skilled in the art will appreciate that compliant balloons may be acceptable in some circumstances when it is expected that less severe conditions will be encountered. Nevertheless, it is believed that the use of a non-compliant balloon is generally superior to a compliant balloon in most cases, and its use is therefore preferred.
• Angioplasty balloons are well known, and those skilled in the art can readily select an appropriate balloon for use in carrying out a particular angioplasty procedure.
• balloon 14 is provided with a plurality of cutters 30 distributed along the outer surface of the balloon.
• Cutters 30 are preferably formed from a polymer.
• cutters 30 are formed from the same base polymer that is used to form balloon 14, or from a base polymer having a similar composition as that of the base polymer. Cutters 30 should, of course, have sufficient strength and rigidity to break down vascular restrictions encountered upon the introduction of the balloon into a body vessel, as discussed hereinafter.
• Cutters 30 are arranged along the outer surface of balloon 14 in a manner that that enables the cutters to break down vascular restrictions.
• Such restrictions commonly comprise arterial plaque, although in more severe cases the restrictions may comprise hardened calcified lesions in the blood vessel.
• the cutters are arranged in the manner shown in the figures.
• each row of cutters preferably includes a plurality of individual cutters 30 arranged in a longitudinal row as shown.
• each row need not include three cutters as shown in the figures, and may include more, or fewer cutters.
• each row will include a plurality of discrete cutters as shown, rather than a single elongated cutter that spans most, if not all, of the length of balloon main body 16.
• the presence of a plurality of aligned cutters as shown and described allows the balloon to more easily bend, or flex, during insertion, or as the balloon traverses tortuous bodily passageways.
• the trackability of a balloon having the multiple cutters is enhanced, when compared to a balloon having a single elongated cutter.
• the lack of flexibility of a balloon having a single elongated cutter increases the risk of disengagement of the cutter as the balloon traverses these passageways.
• the cutters need not be aligned in parallel fashion along a row. Rather, for example, some of the cutters can be arranged as shown, and others may be aligned at any angle to them, such as perpendicular. Furthermore, the cutters need not be arranged in parallel rows as illustrated in the figures. Rather, the cutters can be arranged in any one of an infinite number of configurations along the circumference of the balloon. However, for ease of manufacturing and use, and for versatility in cutting ability, the arrangement shown in the figures is preferred.
• Cutters 30 are best shown in Figs. 6 and 7.
• Cutters 30 preferably include opposing base portions 32 and converging body portions 34. Body portions 34 converge to meet at sharp edge 35.
• the cutters may generally be formed by techniques well known in the art, such as by molding or extrusion.
• the cutters are formed such that the corners or edges 36 are curved, as best shown in Fig. 7. This configuration eliminates the presence of sharp corners or edges, thereby minimizing the possibility of inadvertently cutting the artery during insertion.
• the cutters 30 may be attached to balloon cylindrical body surface 16 by any well-known method utilized in the medical arts for joining components.
• the cutters are bonded to the outer surface of balloon 14.
• Heat bonding is a particularly preferred technique that may be used for forming a strong bond between polymeric compositions.
• Heat bonding is a well-known technique, and those skilled in the art can readily determine appropriate conditions upon which a particular bonding operation may be carried out.
• One particularly preferred heat bonding technique is laser- welding of the cutter to the outer balloon surface.
• Other techniques suitable for a particular bonding operation include, but are not limited to, adhesive bonding and/or solvent bonding. When bonding techniques such as adhesive and/or solvent bonding are carried out, those skilled in the art will appreciate that only biologically compatible materials should be used.
• the cutters may be bonded or otherwise attached to the balloon during the process of forming the balloon.
• balloon 14 can be formed with integral cutter portions 30.
• the cutters 30 and the balloon 14 are formed from the same or a similar polymer in a preferred embodiment of the invention. When the same or similar polymers are utilized for the balloon and the cutters, the bonding of such polymers will normally result in a very favorable and strong seal therebetween.
• the cutters when the cutters are formed of the same or a similar polymer as the balloon, the cutters have the ability to expand as the balloon is expanded, i.e., during inflation of the balloon.
• cutters 30 having opposing base portions 32 and converging edges 34 as shown in Figs. 6 and 7, the cutters need not necessarily have this configuration. Rather, for example, at least some of cutters need only have a single base, with one or more walls leading from the base to a cutting edge. As a still further alternative, cutters 30 need not even have a base and/or a wall, and the cutting edge can be adhered directly to the balloon surface. Nevertheless, for ease of operation, securement of bonding, enhanced trackability or bendability, etc., it is preferred to utilize the cutter configuration shown in Figs. 6 and 7.
• balloon catheter assembly 10 During use of balloon catheter assembly 10 in a balloon angioplasty procedure, the balloon 14 is initially wrapped around catheter shaft 12 in its uninflated condition, as illustrated in Figs. 4 and 5. As shown in Fig. 5, sharp edges 35 of respective cutters 30 are shielded or otherwise covered by balloon folds 17. As a result, edges 35 are not exposed to the portions of the vessel that are traversed during the introduction of assembly 10 into the vessel. In addition, this arrangement protects medical personnel by reducing the possibility of inadvertent contact with a sharp cutter edge. [0033] Those skilled in the art recognize that there are many ways in which a balloon catheter assembly may be introduced into a blood vessel, and accordingly, the inventive balloon catheter assembly 10 may be introduced in any of these well known ways.
• the assembly is introduced over a wire guide that has previously been inserted into a vessel using, e.g., the well-known Seldinger percutaneous entry technique.
• a suitable guide catheter (not shown) may be introduced over the wire guide to provide a conduit for safe passage of the balloon catheter assembly to the site requiring treatment.
• Assembly 10 may then be advanced over the wire guide and through the guide catheter until the area of a vascular restriction, such as a hardened lesion, is encountered.
• the balloon portion of the assembly exits the distal end of the guide catheter and passes into the area of the restriction.
• the catheter shaft may be provided with one or more radiopaque markers in conventional fashion. Although the markers may be spaced at any desired location along the shaft, it is preferred to position them on the portion of the shaft inside of the balloon.
• balloon 14 may be inflated by well-known means. Inflation of the balloon causes the sharp edge 35 of respective cutters 30 to engage and thereby break down the restriction.
• the balloon may be deflated and re-inflated one or more additional times if desired.
• the assembly may also be rotated prior to re- inflation such that additional segments of the restriction may be directly engaged by the cutters.
• the balloon is deflated such that it returns to the general shape illustrated in Fig. 5.
• the balloon catheter assembly may then be retracted over the wire guide, through the guide catheter, and removed from the vessel.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• Pulmonology (AREA)
• Vascular Medicine (AREA)
• Child & Adolescent Psychology (AREA)
• Biophysics (AREA)
• Surgery (AREA)
• Anesthesiology (AREA)
• Hematology (AREA)
• Molecular Biology (AREA)
• Medical Informatics (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Surgical Instruments (AREA)
• Materials For Medical Uses (AREA)

Priority Applications (6)

Applications Claiming Priority (2)

Publications (2)

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Family Applications (1)

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Cited By (4)

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• 2005
  • 2005-12-28 CA CA2585639A patent/CA2585639C/en active Active
  • 2005-12-28 WO PCT/US2005/047054 patent/WO2006073933A2/en not_active Ceased
  • 2005-12-28 DK DK05855586T patent/DK1830915T3/da active
  • 2005-12-28 US US11/319,974 patent/US7303572B2/en active Active
  • 2005-12-28 EP EP05855586A patent/EP1830915B1/en active Active
  • 2005-12-28 AT AT05855586T patent/ATE413204T1/de not_active IP Right Cessation
  • 2005-12-28 JP JP2007549547A patent/JP4940398B2/ja not_active Expired - Fee Related
  • 2005-12-28 AU AU2005323017A patent/AU2005323017B2/en active Active
  • 2005-12-28 DE DE602005010906T patent/DE602005010906D1/de active Active

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