WO2003018099A1 - Segmented balloon catheter blade - Google Patents
Segmented balloon catheter blade Download PDFInfo
- Publication number
- WO2003018099A1 WO2003018099A1 PCT/US2002/010732 US0210732W WO03018099A1 WO 2003018099 A1 WO2003018099 A1 WO 2003018099A1 US 0210732 W US0210732 W US 0210732W WO 03018099 A1 WO03018099 A1 WO 03018099A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- blade
- balloon
- stenosis
- base member
- recited
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus 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 the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus 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
- 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
Definitions
- the present invention relates generally to medical devices. More particularly, the present invention pertains to invasive surgical devices which are useful for the incision and dilation of a stenosis in the vasculature of a patient. The present invention is particularly, though not exclusively, useful for incising a stenosis with a balloon catheter blade to facilitate subsequent dilation of the stenosis.
- the blockage of human arteries can lead to a variety of serious medical complications. This is so because arterial blockages reduce blood flow through the affected artery and may result in damage to the tissue that is relying on the blood supply. For example, if the blockage is in an artery which supplies blood to the heart itself, a heart attack may result.
- Such arterial blockages which are also called stenoses, are typically caused by the build-up of atherosclerotic plaque on the inside wall of an artery.
- several such stenoses may occur contiguously within a single artery. This can result in a partial, or even complete, blockage of the artery.
- a method and procedures have been developed to treat stenoses.
- One such method is an angioplasty procedure which uses an inflatable balloon to dilate the blocked artery.
- a typical inflatable angioplasty device for example, is disclosed in U.S. Patent No. 4,896,669 which issued to Bhate et al. for an invention entitled "DILATION CATHETER". The Bhate et al.
- angioplasty device includes an inflatable angioplasty balloon which is insertable into a peripheral artery of a patient for positioning across a stenosis. Once positioned, the angioplasty balloon is then inflated to flatten the stenosis against the inside wall of the artery thereby improving the blood flow through the artery.
- Angioplasty balloons have enjoyed widespread acceptance in the treatment of stenoses. Recent studies, however, have indicated that the efficacy of the dilation of a stenosis is enhanced by first, or simultaneously, incising the material that is creating the stenosis.
- the atherotomes Upon inflation of the Barath balloon, the atherotomes induce a series of longitudinal cuts into the surface of the stenotic material as the balloon expands to dilate the stenosis. As a result of such cuts, the stenosis is more easily flattened, and the likelihood of damaging the artery during dilation is reduced. Generally, however, the surface of a stenosis is bumpy and undulating, and contains numerous peaks and valleys. As such, incision of a stenosis with one long, continuous blade that is mounted on the surface of an angioplasty balloon can be uneven.
- a device for incising a stenosis in the vasculature of a patient includes a plurality of blade segments that are mounted and aligned on a base member.
- the base member is mounted on the external surface of an inflatable angioplasty balloon. Accordingly, when the balloon is inserted into the vasculature of a patient, positioned across a stenosis and subsequently inflated, the blade segments form an effective cutting edge that effectively conforms to the surface of the stenosis. Due to this ability of the cutting edge to conform with the peaks and valleys of the stenosis, the stenosis can be incised to a substantially uniform depth.
- each individual blade segment is generally elongated and defines a blade axis in the direction of its elongation.
- each blade segment is mounted on the base member and oriented with its blade axis either substantially parallel or substantially colinear with the blade axis of at least one other blade segment.
- the distal portion of each blade segment is juxtaposed and preferably in contact with the proximal portion of the next closest blade segment (except for the blade segment at the extreme distal end of the pattern). As such, each blade segment is off-set from the next closest blade segment in the axial direction.
- the base member is made of a resilient material, such as a thin strip of polyurethane material, which allows the base member to deform along with the surface of the angioplasty balloon during an inflation or deflation of the balloon.
- One side of the base member is preferably bonded to the external surface of the angioplasty balloon.
- an elongated angioplasty balloon defining a balloon axis in the direction of elongation, is generally used.
- the base member is also elongated and is mounted on the external surface of the balloon with the direction of base member elongation parallel to the balloon axis.
- each blade segment is mounted on the base member with each blade axis substantially parallel to the direction of base member elongation. Furthermore, each blade segment is formed with a taper section that creates a sharpened edge. Preferably, each blade segment is oriented on the base member with the sharpened edge of each blade segment lying substantially along a single continuous cutting line.
- a catheter having an angioplasty balloon, base member and blade segments is inserted into the vasculature of a patient.
- the catheter is then advanced within the vasculature until the angioplasty balloon is positioned across a stenosis requiring treatment.
- a guidewire can be used to establish a mechanical pathway to assist the catheter to the treatment site.
- the balloon is slowly inflated causing the external surface of the balloon, the base member and the blade segments to move outwardly together in a radial direction from the balloon axis until the blade segments contact the surface of the stenosis.
- each blade segment Upon contact with the surface of the stenosis, the sharpened edge of each blade segment cuts into the stenosis, creating an incision. Inflation of the balloon is then continued until the blade segments are effectively embedded into the stenosis. Eventually, the external surface of the balloon and the resilient base member contact and conform with the surface of the stenosis. Because the blades are segmented and positioned on the base member to allow relative movement between blade segments, the blade segments do not prevent the balloon and base member from conforming to the surface of the stenosis. Additionally, the relative movement between the blade segments allows the blade segments to form an effective cutting edge that conforms to the surface of the stenosis resulting in a nearly continuous incision of substantially uniform depth along the surface peaks and valleys of the stenosis.
- the angioplasty balloon can be further inflated to dilate the stenosis, if desired. In any case, the angioplasty balloon is subsequently deflated to withdraw the blade segments from the stenosis. Once deflated, the balloon and blade segments can be repositioned for treatment of another stenosis or removed from the patient.
- Fig. 1 is a perspective view of a patient with a device in accordance with the present invention positioned in an artery to allow for the incision of a stenosis;
- Fig. 2 is an enlarged perspective view of a balloon catheter having segmented blades in accordance with the present invention (balloon shown in inflated configuration);
- Fig. 3 is an enlarged elevation view of a blade unit having three segmented blades mounted on a base member (dotted lines are provided to show portions of the two outer blades that are behind the center blade for clarity);
- Fig. 4 is an enlarged plan view of a blade unit having three segmented blades mounted on a base member;
- Fig. 5 is a sectional view of the blade unit as seen along line 5-5 in Fig. 4;
- Fig. 6 is a sectional view of the blade unit as seen along line 6-6 in Fig. 4; and Fig. 7 is a cross-sectional view of a balloon catheter having segmented blades positioned across a stenosis in the vessel of a patient and inflated to embed the blades into the stenosis.
- a device 10 for incising and dilating a stenosis is shown positioned for operation inside a patient 12.
- the device 10 includes an angioplasty balloon 14 that is elongated and defines a balloon axis 16.
- lumen 18 is provided to allow the balloon 14 to be tracked along a guidewire 20 (shown in Fig. 1) and to allow for inflation/deflation of the balloon 14.
- one or more blade units such as blade unit 22 and blade unit 24 are mounted on the external surface of the angioplasty balloon 14.
- the blade unit 22 includes a base member 26 and a plurality of blade segments 28a, 28b and 28c. Although only three blade segments 28a, 28b, 28c are shown, it is to be appreciated that a blade unit 22 can contain any number of blade segments 28a, 28b, 28c for the present invention.
- each blade segment 28a, 28b, 28c is made of a hard, biocompatible material such as stainless steel. As shown, each blade segment 28a, 28b, 28c is generally elongated and defines a blade axis 30 in the direction of elongation.
- each blade segment 28a, 28b, 28c is mounted on the base member 26 and oriented with its blade axis 30a, 30b, 30c either substantially parallel or substantially colinear with the blade axis 30a, 30b, 30c of at least one other blade segment 28a, 28b, 28c.
- Attachment of the blade segments 28a, 28b, 28c to the base member 26 can be accomplished using any method known in the pertinent art such as bonding pre-formed blade segments 28a, 28b, 28c to the base member 26 with an adhesive.
- the blade segments 28a, 28b, 28c are arranged on the base member 26 in a pattern to allow each blade segment 28a, 28b, 28c to move independently of the other blade segments 28a, 28b, 28c. Specifically, as shown and identifying a distal direction to the right and a proximal direction to the left in Fig. 4, the distal portion 32 of blade segment 28a is juxtaposed with the proximal portion 34 of blade segment 28b. Similarly, the distal portion 36 of blade segment 28b is juxtaposed with the proximal portion 38 of blade segment 28c.
- every other blade segment 28a, 28b, 28c along the pattern are aligned parallel to a common axis, such as axis 40.
- blade segment 28b is off-set from blade segment 28a and blade segment 28c in the direction of axis 40.
- the size and shape of each blade segment 28a, 28b, 28c, the amount of the off-set, and the extent of the portions that are juxtaposed can be varied depending on the particular application.
- blade segment 28a is formed with a tapered section 39 that creates a sharpened edge 41 of the blade segment 28a.
- the tapered section 39a, 39b, 39c of each respective blade segment 28a, 28b and 28c preferably inclines toward a cutting line 43.
- the sharpened edge 41a, 41b, 41c of each blade segment 28a, 28b, 28c preferably lies substantially along the cutting line 43.
- the base member 26 is made of a resilient material, such as a thin strip of polyurethane material, allowing the base member 26 to deform along with the angioplasty balloon 14 during inflation, deflation and contact with the stenosis.
- one side of the base member 26 is preferably bonded to the external surface of the angioplasty balloon 14.
- the base member 26 is preferably elongated and is mounted on the external surface of the balloon 14 with the direction of elongation of the base member 26 parallel to the balloon axis 16. Accordingly, the blade segments 28a, 28b, 28c are aligned substantially parallel to the balloon axis 16.
- a catheter 42 having a device 10 that includes an angioplasty balloon 14, base member 26 and blade segments 28a, 28b, 28c is first inserted into a vessel 44 of a patient 12.
- the catheter 42 is advanced in the vessel 44 until the angioplasty balloon 14 is positioned across the stenosis 46.
- a guidewire 48 can be used to establish a mechanical pathway to assist the catheter 42 to the treatment site.
- the balloon 14 is slowly inflated causing the external surface of the balloon 14, the base member 26 and the blade segments 28a, 28b, 28c to move outwardly in a radial direction from the balloon axis 16 until the blade segments 28a, 28b, 28c contact the surface 50 of the stenosis 46.
- inflation of the balloon 14 will cause one or more of the blade segments 28a, 28b, 28c to contact the surface 50 of the stenosis 46 and cut an incision in the stenosis 46.
- Continued inflation of the balloon 14 causes one or more blade segments 28a, 28b, 28c to embed into the stenosis 46.
- the external surface of the balloon 14 and the resilient base member 26 contact and conform with the surface 50 of the stenosis 46. Because of the articulation and offset of the blade segments 28a, 28b, 28c, the blade segments 28a, 28b, 28c are able to move independently and the blade segments 28a, 28b, 28c do not prevent the balloon 14 and base member 26 from conforming to the surface 50 of the stenosis 46. Additionally, as shown, the relative movement between the blade segments 28a, 28b, 28c allows the blade segments 28a, 28b, 28c to form an effective cutting edge along the cutting line 43 (shown in Fig. 4) that conforms to the surface 50 of the stenosis 46 resulting in a nearly continuous incision of substantially uniform depth along the surface peaks and valleys of the stenosis 46.
- the angioplasty balloon 14 can be further inflated to dilate the stenosis 46, if desired. After treatment, the angioplasty balloon 14 is subsequently deflated, withdrawing the blade segments 28a, 28b, 28c from the stenosis 46. Once deflated, the balloon 14 can be re-inflated to repeat the process, if desired. After treatment of the stenosis 46, the deflated balloon 14 can be repositioned for treatment of another stenosis 46 or removed from the patient 12.
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2003522612A JP4170904B2 (en) | 2001-08-23 | 2002-04-04 | Split balloon, catheter, blade |
EP02796180A EP1427470B1 (en) | 2001-08-23 | 2002-04-04 | Segmented balloon catheter blade |
DE60216294T DE60216294T2 (en) | 2001-08-23 | 2002-04-04 | SEGMENTED BALLOON CATHETER BLADE |
CA002458366A CA2458366C (en) | 2001-08-23 | 2002-04-04 | Segmented balloon catheter blade |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/938,010 | 2001-08-23 | ||
US09/938,010 US6632231B2 (en) | 2001-08-23 | 2001-08-23 | Segmented balloon catheter blade |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2003018099A1 true WO2003018099A1 (en) | 2003-03-06 |
Family
ID=25470724
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2002/010732 WO2003018099A1 (en) | 2001-08-23 | 2002-04-04 | Segmented balloon catheter blade |
Country Status (7)
Country | Link |
---|---|
US (3) | US6632231B2 (en) |
EP (1) | EP1427470B1 (en) |
JP (1) | JP4170904B2 (en) |
AT (1) | ATE345832T1 (en) |
CA (1) | CA2458366C (en) |
DE (1) | DE60216294T2 (en) |
WO (1) | WO2003018099A1 (en) |
Cited By (1)
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JP2008526312A (en) * | 2004-12-30 | 2008-07-24 | クック インコーポレイテッド | Catheter assembly with plaque cutting balloon |
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Also Published As
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US20040098018A1 (en) | 2004-05-20 |
CA2458366C (en) | 2009-12-15 |
DE60216294T2 (en) | 2007-06-14 |
JP4170904B2 (en) | 2008-10-22 |
US6632231B2 (en) | 2003-10-14 |
US20040127920A1 (en) | 2004-07-01 |
EP1427470B1 (en) | 2006-11-22 |
EP1427470A4 (en) | 2004-11-03 |
JP2005507683A (en) | 2005-03-24 |
US20030040770A1 (en) | 2003-02-27 |
US7172609B2 (en) | 2007-02-06 |
US7011670B2 (en) | 2006-03-14 |
EP1427470A1 (en) | 2004-06-16 |
ATE345832T1 (en) | 2006-12-15 |
CA2458366A1 (en) | 2003-03-06 |
DE60216294D1 (en) | 2007-01-04 |
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