Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
  • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
  • A61F2/958—Inflatable balloons for placing stents or stent-grafts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2/06—Blood vessels
  • A61F2002/065—Y-shaped blood vessels
• • 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
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M2025/0034—Multi-lumen catheters with stationary elements characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• • 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
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side

Definitions

• the present invention relates to an endovascular sleeve for use in delivery of a bifurcated stent.
• the present invention relates to bifurcated stent delivery kit.
• the present invention relates to a method for delivery of a bifurcated stent.
• Stents are generally known. Indeed, the term “stent” has been used interchangeably with terms such as “intraluminal vascular graft” and “expansible prosthesis”. As used throughout this specification, the term “stent” is intended to have a broad meaning and encompasses any expandable prosthetic device for implantation in a body passageway (e.g., a lumen or artery).
• a body passageway e.g., a lumen or artery
• body passageway is intended to have a broad meaning and encompasses any duct (e.g., natural or iatrogenic) within the human body and can include a member selected from the group comprising: blood vessels, respiratory ducts, gastrointestinal ducts and the like.
• Stent development has evolved to the point where the vast majority of currently available stents rely on controlled plastic deformation of the entire structure of the stent at the target body passageway so that only sufficient force to maintain the patency of the body passageway is applied during expansion of the stent.
• a stent in association with a balloon, is delivered to the target area of the body passageway by a catheter system. Once the stent has been properly located (for example, for intravascular implantation the target area of the vessel can be filled with a contrast medium to facilitate visualization during fluoroscopy), the balloon is expanded thereby plastically deforming the entire structure of the stent so that the latter is urged in place against the body passageway.
• the amount of force applied is at least that necessary to expand the stent (i. e. , the applied the force exceeds the minimum force above which the stent material will undergo plastic deformation) while maintaining the patency of the body passageway.
• the balloon is deflated and withdrawn within the catheter, and is subsequently removed.
• the stent will remain in place and maintain the target area of the body passageway substantially free of blockage (or narrowing).
• Palmaz-Schatz stent when installed, admittedly shields side branches emanating from the target area of the body passageway effectively permanently. This can be problematic since the only way to treat blockage or other problems associated with the side branches is to perform the type of surgery which installation of the stent was intended to avoid.
• Interventional Cardiovascular Medicine Principles and
• any stent (monotubular or bifurcated) it is reasonably well accepted that the stent is mounted on a catheter which is navigated over a guidewire previously inserted through a guide catheter to the target location.
• a pair of guidewires would be used - i.e., one for each of the two passageways that branch off the primary passageway.
• the guidewires do not become entangled, either in the guide catheter or the body passageway, as this will prevent navigation of the catheter to the target location.
• the limited size of the guide catheter determines the bulkiness of the bifurcated stent delivery system. The practical result of this is that the current approach of delivering bifurcated stents is bulky, cumbersome and technically challenging. To date, the present inventors are unaware of a solution to the problems of conventional bifurcated stent delivery.
• the present invention provides an endovascular sleeve for delivering a pair of guidewires to a bifurcated body passageway, the sleeve comprising a first tubular passageway and a second tubular passageway fixed with respect to one another, the first tubular passageway comprising a first distal end and a first proximal end, the second tubular passageway comprising a second distal end and a second proximal end, the first distal end being longer than the second distal end to define a junction which abuts against a crotch in the bifurcated body passageway.
• a bifurcated stent delivery kit for delivery of a bifurcated stent to a bifurcated body passageway, the kit comprising: a catheter; a pair of guidewires; and an endovascular sleeve for delivering the guidewires to a bifurcated body passageway, the sleeve comprising a first tubular passageway and a second tubular passageway fixed with respect to one another, the first tubular passageway comprising a first distal end and a first proximal end, the second tubular passageway comprising a second distal end and a second proximal end, the first distal end being longer than the second distal end to define a junction which abuts against a crotch in the bifurcated body passageway.
• the present invention provides method for delivery of a bifurcated stent to a target bifurcated body passageway having a proximal body passageway, a first distal body passageway and a second distal body passageway using an endovascular sleeve comprising a first tubular passageway and a second tubular passageway fixed with respect to one another, the first tubular passageway comprising a first distal end and a first proximal end, the second tubular passageway comprising a second distal end and a second proximal end, the first distal end being longer than the second distal end to define a junction which abuts against a crotch in the bifurcated body passageway, the method comprising the steps of:
• the present inventors have developed an endovascular sleeve which can be utilized to navigate a pair of guidewires to a bifurcated body passageway such that, once in place, the guidewires are substantially untwisted or untangle. This greatly facilitates delivery of the bifurcated stent to the bifurcated artery.
• Figure 1 illustrates a side elevation of a first embodiment of the present endovascular sleeve
• Figure 2 illustrates a side elevation of a second embodiment of the present endovascular sleeve
• Figures 3-7 illustrate enlarged views of how the present endovascular sleeve may be used to deliver a pair of guidewires
• Figures 8-12 illustrate perspective views of how the present endovascular sleeve may be used to deliver a pair of guidewires
• Figures 13-15 illustrate enlarged view of how a bifurcated stent may be delivered once the pair of guidewires are in place; and Figure 16 illustrates an enlarged view of the implanted bifurcated stent delivered in Figures 13-15.
• Endovascular sleeve 10 comprises a first tubular passageway 20 having a first distal end 22 and first proximal end 24.
• Endovascular sleeve 10 further comprises a second tubular passageway 30 having a second distal end 32 and second proximal end 34.
• First tubular passageway 20 and second tubular passageway 30 are joined and fixed with respect to one another along a seam 40. As illustrated, first distal end 22 extends beyond second distal end 32.
• first distal end 22 extends beyond second distal end 32 by a margin of at least about 0.3 cm, more preferably by a margin in the range of from about 0.3 cm to about 3 cm, most preferably by a margin in the range of from about 0.5 cm to about 2 cm.
• first proximal end 24 is significantly offset with respect to second proximal end 34. As will be developed below, this offset renders endovascular sleeve 10 as a "over-the- wire/monorail" delivery system. As shown, each of first distal end 22 and second distal end 32 are chamfered or bevelled. With reference to Figure 2, there is shown an endovascular sleeve 100.
• Endovascular sleeve 100 comprises a first tubular passageway 120 having a first distal end 122 and first proximal end 124. Endovascular sleeve 100 further comprises a second tubular passageway 130 having a second distal end 132 and second proximal end 134. First tubular passageway 120 and second tubular passageway 130 are joined and fixed with respect to one another along a seam 140. As illustrated, first distal end 122 extends beyond second distal end 132. This offset between first distal end 122 and second distal end 132 defines a junction 145.
• first distal end 122 extends beyond second distal end 132 by a margin of at least about 0.3 cm, more preferably by a margin in the range of from about 0.3 cm to about 3 cm, most preferably by a margin in the range of from about 0.5 cm to about 2 cm.
• first proximal end 124 is substantially even with respect to second proximal end 134. This relatively even disposition of first proximal end 124 and second proximal end 134 renders endovascular sleeve 100 as a "double over-the-wire" delivery system.
• each of first distal end 122 and second distal end 132 are chamfered or bevelled.
• the material used to constructed endovascular sleeve 10 is not particularly restricted provided of course that it: (i) sufficient integrity to by navigated through tortuous body passageways, and (ii) is non-toxic to the subject in which endovascular sleeve 10 is being navigated.
• suitable materials include bioplastic polymers, a flexible metal tube and the like.
• a bifurcated body passageway 50 comprises a proximal passageway 52 and a pair of distal passageways 54,56.
• the junction of distal passageways 54,56 defines a crotch 58.
• the stenosis of bifurcated body passageway 50 is not illustrated.
• a first guidewire 60 is navigated through proximal passageway 52 and into distal passageway 54 in the direction of arrow A.
• first tubular passageway 20 is fed over guidewire 60 in the direction of arrow A and navigated until it enters distal passageway 54 and junction 40 of endovascular sleeve 10 abuts crotch 58 of bifurcated body passageway 50.
• endovascular sleeve 10 is provided with a radioopaque marker (e.g., made of gold and the like) near or at junction 40 so that the position of junction 40 relative to crotch 58 can be monitored using conventional image radiography techniques.
• a radioopaque marker e.g., made of gold and the like
• FIG. 8-12 there are illustrated perspective views of the use of endovascular sleeve 10 to deliver a pair of guidewires as described hereinabove with respect to Figures 3-7.
• endovascular sleeve 10 is introduced to a subject 70 via a suitable incision near the groin of subject 70.
• the concordance of the perspectives view illustrated in Figures 8-12 to the enlarged view illustrated in Figures 3-7 is as follows:
• Figures 9 and 10 concord with Figure 4; Figure 11 concords with Figure 5; and Figure 12 concords with Figures 6 and 7.
• endovascular sleeve 10 may be regarded as an "over- the-wire/monorail" delivery system.
• one tubular passageway (30) remains over a guidewire (62) such that the proximal end thereof (34) emanates from the subject whereas the proximal end (24) of the other tubular passageway (20) does not emanate from the subj ect.
• the section of the other tubular passageway (20) between the bifurcated body passageway (50) and incision (72) in the subj ect (70) does not completely cover the other guidewire (60).
• endovascular sleeve 100 may be regarded as a "double over-the-wire" delivery system. By this is meant that, once the sleeve is in the correct position, both tubular passage ways (120,130) remain over their respective guidewires (60,62) such that the proximal end (24) of each tubular passageway (120,130) emanates from the subject. In other words, both guidewires (60,62) are substantially completely covered by endovascular sleeve 100.
• a catheter 80 is used to deliver a bifurcated stent to bifurcated body passageway 50.
• catheter 80 comprises a balloon 82 having a pair of tubes 84,86 emanating from one end thereof.
• tubes 84,86 are of a conventional, annular design such that they can be disposed over their respective guidewires and can receive a fluid which is used to fill balloon 82 resulting in expansion thereof.
• catheter 80 is navigated over guidewires 60,62 until the bifurcated stent is in the correct position - see Figure 14.
• a pressurized fluid e.g., saline
• tubes 84,86 resulting in expansion of balloon 82 and stent 88 - see Figure 15.
• balloon 82 is deflated conventionally and withdrawn from bifurcated body passage way 50 leaving stent 88 in a deployed state - see Figure 16. While balloon 82 is shown as a pair of adjacent single balloons, those of skill in the art will appreciate that a bifurcated balloon could be used in place of a pair of single balloons.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Cardiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Life Sciences & Earth Sciences (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)
• Prostheses (AREA)

Priority Applications (7)

Applications Claiming Priority (2)

Publications (1)

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Family Applications (1)

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Cited By (7)

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Citations (13)

• 1999
  • 1999-07-29 AU AU50231/99A patent/AU762447B2/en not_active Ceased
  • 1999-07-29 NZ NZ510186A patent/NZ510186A/en not_active IP Right Cessation
  • 1999-07-29 NZ NZ52764899A patent/NZ527648A/en not_active IP Right Cessation
  • 1999-07-29 CA CA002339133A patent/CA2339133C/en not_active Expired - Fee Related
  • 1999-07-29 WO PCT/CA1999/000695 patent/WO2000007523A1/en not_active Application Discontinuation
  • 1999-07-29 CN CNB998091723A patent/CN1171565C/zh not_active Expired - Fee Related
  • 1999-07-29 JP JP2000563210A patent/JP4435981B2/ja not_active Expired - Fee Related
  • 1999-07-29 EP EP99934434A patent/EP1100410A1/en not_active Ceased

Patent Citations (18)

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