JP5824506B2 - Selective stent crimp - Google Patents

Description

(Field of Invention)
The present invention relates to medical devices, and more specifically to stent placement and branch vessel treatment. Stents are typically delivered subcutaneously to treat veins, arteries, or blood vessels to treat occlusions, stenosis, aneurysms, collapse, dissection, or weakening, affected, or abnormally dilated vessels or vessel walls An implantable scaffold deployed in other tubular body organs. The stent is radially expanded in situ, thereby expanding and / or supporting the vessel wall or body organ. Specifically, stents are very commonly implanted in the coronary arteries, heart, lungs, neurovascular, peripheral blood vessels, kidneys, gastrointestinal tract, and genital system, and include ureters, bile ducts, esophagus, tracheobronchial tree, and brain Has been successfully embedded in these body organs to strengthen.

  Stents are often used to improve the outcome of angioplasty by preventing elastic contraction and remodeling the vessel wall, and by compressing the intimal flap together in the lumen at the site of dissection, and Used to treat vessel wall dissociation caused by peripheral artery balloon angioplasty. Conventional stents are used to treat more complex vascular problems, such as lesions at or near bifurcations in the vasculature, where secondary arteries typically branch off from the large aorta, The success rate is limited.

  Conventional stent technology is relatively well developed. Conventional stent designs typically feature a straight tubular single-cell structure, configuration, or pattern that repeats through translation along the longitudinal axis. In many stent designs, repetitive structures, configurations, or patterns have struts and connecting balloon catheter portions that can block blood flow at the vessel bifurcation.

  In addition, the configuration of the struts and connecting balloon catheter portions may interfere with the use of post-operative devices for treating daughter vessels in the region of the vessel bifurcation. For example, the deployment of the first stent in the mother lumen can include dislocation, thrombus with or without displaced affected tissue (eg, platelet migration or “snow plow”), occlusion, vasospasm, intimal flap If the treatment of the mother vessel is suboptimal due to emboli, and / or other vascular diseases, the physician may be prevented from inserting the daughter stent through the daughter vessel mouth of the vessel branch. Conventional stents are designed with the conflicting considerations of covering versus access. For example, to facilitate coating, the cellular structure size of the stent may be minimized to optimally support the vessel wall, thereby avoiding or reducing tissue escape. To facilitate access, the cell size provides access to the blood vessels and daughter vessels of the daughter stent that may be implanted in the future, thereby preventing “stent detention” and the embedded material May be maximized to minimize the amount of. Conventional stent designs typically compromise one consideration with the other in an attempt to address both. The problems we observed with daughter detention, risk of platelet migration, complete occlusion, and difficulty of procedure are easier to use to treat the various vascular diseases indicated above and We continue to drive the inventor to develop new delivery systems that are safe and reliable. Conventional stents are routinely used in clinical procedures, but clinical data show that these stents cannot completely prevent in-stent restenosis (ISR) or restenosis caused by intimal hyperplasia It shows that. In-stent restenosis is the reoccurrence of arterial stenosis or occlusion in an area covered by a stent after implantation. Patients treated with coronary stents can suffer from in-stent restenosis.

  Many pharmacological attempts have been made to reduce the amount of restenosis caused by intimal hyperplasia. Many of these trials have addressed systemic delivery of drugs via oral or intravascular introduction. However, the success of the systemic approach is limited.

  Systemic delivery of drugs is essential because it is difficult to achieve constant drug delivery to the affected area, and systemically administered drugs often repeat up and down concentrations, resulting in periods of toxicity and ineffectiveness. Limited. Therefore, in order to be effective, the anti-restenosis drug should be delivered in a localized manner. One approach for local drug delivery utilizes a stent as the delivery vehicle. For example, stents seeded with transfected endothelial cells expressing bacterial β-galactosidase or human tissue-type plasminogen activator have been utilized as therapeutic protein delivery vehicles. For example, see Non-Patent Document 1. Patent Literature 1, Patent Literature 2 entitled “Intraluminal Drug Eluting Prosthesis”, Patent Literature 3 entitled “Stent With Sustained Drug Delivery” are antiplatelet agents, antiaggregation agents, antimigration agents, and other Disclosed is a stent device capable of delivering an anti-restenosis drug. Patent Literature 4, Patent Literature 5, Patent Literature 6, Patent Literature 7, Patent Literature 8, Patent Literature 9, Patent Literature 10, and Patent Literature 11 are coated with various pharmaceuticals such as rapamycin, 17β estradiol, taxol, and dexamethasone. Taught stents. This patent and all other referenced patents are hereby incorporated by reference in their entirety. Further, the definition or use of a term in a reference that is incorporated herein by reference is the definition of that term as provided herein, or the definition to which that term applies as provided herein. , And inconsistent or contrasting with definitions that the term does not apply in the references.

US Pat. No. 5,679,400 International Publication No. 91/12779 International Publication No. 90/13332 US Pat. No. 6,273,913 US Pat. No. 6,383,215 US Pat. No. 6,258,121 US Pat. No. 6,231,600 US Pat. No. 5,837,008 US Pat. No. 5,824,048 US Pat. No. 5,679,400 US Pat. No. 5,609,629

Dichek, D.D. A. et al. , “Seeding of Intravascular Stents with Genetically Engineered Endothelial Cells,” Circulation, 80: 1347-1353 (1989).

  Thus, in view of current stent technology challenges, there is a need for improved stent delivery systems, methods of use, and manufacturing methods, particularly for treating branch vessels. At least some of these objectives will be met by the present invention.

The present invention provides, for example:
(Item 1)
A method of crimping a stent on an expandable member of a delivery catheter, the method comprising:
Placing a stent having a first portion and a second portion on the expandable member, the stent including a sidewall through which a side hole extends;
Crimping the stent to the expandable member non-uniformly;
Including a method.
(Item 2)
The method of claim 1, wherein the first portion is uniformly crimped to the expandable member and the second portion is crimped non-uniformly to the expandable member.
(Item 3)
The method of item 2, wherein the first portion of the stent is crimped uniformly circumferentially and longitudinally along itself.
(Item 4)
The method of item 2, wherein the second portion of the stent is crimped non-uniformly circumferentially along itself.
(Item 5)
The method of claim 1, wherein the first portion of the stent is disposed distal to the second portion of the stent.
(Item 6)
6. The method of item 5, wherein the first portion is disposed distal to the side hole and the second portion is disposed proximal to the side hole.
(Item 7)
The method of claim 1, wherein the first portion of the stent is crimped using a constriction opening.
(Item 8)
The stent includes a side wall through which a plurality of openings penetrates;
The method of claim 1, wherein the expandable member protrudes at least partially into one or more of the openings.
(Item 9)
9. The method of item 8, further comprising partially inflating the expandable member prior to or during the crimp.
(Item 10)
10. The method of item 9, wherein the expandable member is inflated during the crimp to a pressure in the range of about 50 psi to about 100 psi.
(Item 11)
9. The method of item 8, further comprising heating at least one of the expandable member or the stent before or during the crimp.
(Item 12)
12. The method of item 11, wherein the at least one expandable member or stent is heated to a temperature in the range of about 50 degrees Celsius to about 65 degrees Celsius.
(Item 13)
Applying a vacuum pressure to the expandable member;
Checking for leaks while the vacuum pressure is applied to the expandable member;
The method according to Item 1, further comprising:
(Item 14)
Inflating the expandable member at least partially;
Checking for leakage while the expandable member is at least partially inflated;
The method according to Item 1, further comprising:
(Item 15)
Further comprising crimping the second portion of the stent such that the second portion of the stent is partially crimped to the expandable member, whereby the second portion is expandable. Item 2. The method of item 1, wherein a portion of the member remains uncrimped to the expandable member.
(Item 16)
The method of item 1, further comprising partially crimping the second portion to the expandable member, thereby allowing slidable movement of the elongate shaft underneath.
(Item 17)
The method of claim 1, wherein the first portion and the second portion are crimped while still allowing the elongate shaft to slidably pass through the side holes.
(Item 18)
16. The method of item 15, wherein the second portion of the stent is crimped using a shrink port.
(Item 19)
The second portion of the stent includes a sidewall through which a plurality of openings extend;
16. The method of item 15, wherein the expandable member projects at least partially into one or more of the openings.
(Item 20)
16. The method of item 15, further comprising heating at least one of the expandable member or the second portion of the stent prior to or during the crimping of the second portion of the stent.
(Item 21)
21. The method of item 20, wherein at least one of the expandable member or the second portion of the stent is heated to a temperature in the range of about 50 degrees Celsius to about 65 degrees Celsius.
(Item 22)
16. The method of item 15, further comprising sending an elongate shaft through the side hole under the second portion of the stent for delivery outside the first portion.
(Item 23)
Crimping the second portion of the stent,
Placing a spacer between a portion of the elongated shaft and a portion of the second portion of the stent;
Crimping a portion of the second portion of the stent to contact the spacer;
Removing the spacer, wherein the elongate shaft is slidably disposed relative to a second portion of the stent prior to deployment of the stent;
The method according to item 22, comprising:
(Item 24)
24. The method of item 23, wherein the spacer comprises a protective sheath.
(Item 25)
23. The method of item 22, further comprising partially expanding the expandable member prior to or during the crimping of the second portion of the stent.
(Item 26)
24. The method of item 22, wherein crimping the second portion of the stent comprises crimping a portion of the second portion of the stent to contact the elongate shaft.
(Item 27)
27. The method of item 26, wherein the elongate shaft is slidably disposed with respect to a second portion of the stent after deployment of the stent.
(Item 28)
The method of claim 1, wherein a portion of the second portion is crimped to a portion of the expandable member.
(Item 29)
The method of claim 1, further comprising coating the stent with a therapeutic agent.
(Item 30)
30. The method of item 29, wherein the therapeutic agent prevents restenosis.
(Item 31)
A device for treating a bifurcated body lumen, the device comprising:
A first delivery catheter includes a first elongate shaft having a proximal end and a distal end, and a first extension adjacent to the distal end of the first elongate shaft. An expandable member and a first radially expandable stent disposed on the first expandable member;
The first stent includes a sidewall through which a side hole extends,
The first stent has a folded configuration and an expanded configuration, in which the first stent is coupled with the first expandable member, wherein the first stent is in the expanded configuration. Support the vessel wall,
The device, wherein the first stent is crimped non-uniformly to the first expandable member.
(Item 32)
The first stent includes a first portion and a second portion;
32. The device of item 31, wherein the second portion of the first stent is crimped non-uniformly to the first expandable member.
(Item 33)
The device of item 32, wherein the first portion of the first stent is disposed distally than the second portion of the first stent.
(Item 34)
The first portion of the first stent includes a sidewall through which a plurality of openings extend;
The device of item 32, wherein the expandable member protrudes at least partially into one or more of the openings.
(Item 35)
An annular passage connected to the side hole is oriented along a second portion of the first stent and between the second portion of the first stent and the first expandable member. The device of item 32, wherein the device is deployed.
(Item 36)
32. The device of item 31, wherein the first stent is coated with a therapeutic agent.
(Item 37)
38. The device of item 36, wherein the therapeutic agent prevents restenosis.
(Item 38)
A second delivery catheter further includes a second elongate shaft having a proximal end and a distal end, and a second adjacent to the distal end of the second elongate shaft. An expandable member and a second radially expandable stent disposed on the second expandable member;
The second stent has a folded configuration and an expanded configuration, wherein the second stent is uniformly crimped to the second expandable member, and in the expanded configuration, the second stent The stent supports the vessel wall,
36. The device of item 35, wherein a portion of the second delivery catheter passes through the annular passage and the side hole of the first stent.
(Item 39)
40. The device of item 38, wherein the first expandable member and the second expandable member are expandable independently of each other.
(Item 40)
40. The device of item 38, wherein the second delivery catheter is slidable axially relative to the first delivery catheter when the first stent is in the collapsed configuration.
(Item 41)
40. The device of item 38, wherein the second portion of the first stent is crimped onto the second delivery catheter.
(Item 42)
42. The device of item 41, wherein the second delivery catheter is slidable axially relative to the first delivery catheter when the first stent is in the expanded configuration.
(Item 43)
40. The device of item 38, wherein the second stent is coated with a therapeutic agent.
(Item 44)
44. The device of item 43, wherein the therapeutic agent prevents restenosis.
(Item 45)
A method for treating bifurcation comprising:
Providing a first delivery catheter, the first delivery catheter comprising a first shaft, a first expandable member, and a first stent crimped on the first expandable member Having
Providing a second delivery catheter, the second delivery catheter having a second shaft having a second shaft, a second expandable member, and a side hole, the second delivery catheter comprising: The stent has a first portion that is crimped uniformly on the second expandable member and a second portion that is partially crimped on the second expandable member;
Slidably advancing the first shaft out of the side hole under the partially crimped second portion of the stent, whereby the first shaft is Sliding on the uniformly crimped first portion of the stent;
Including a method.
(Item 46)
46. The method of item 45, further comprising expanding the second expandable member, thereby deploying the second stent in a body lumen.
(Item 47)
Slidably retracting the first shaft relative to the deployed second stent, thereby deploying the first stent adjacent to the second stent. 47. The method of item 46, wherein the first expandable member is installed to do so.
(Item 48)
48. The item 47, further comprising expanding the first expandable member to deploy the first stent in a body lumen adjacent to the second stent. Method.
(Item 49)
A method for treating bifurcation comprising:
Providing a first delivery catheter, wherein the first delivery catheter is crimped uniformly on a first shaft, a first expandable member, and the first expandable member. Having a stent of
Providing a second delivery catheter, the second delivery catheter having a second shaft having a second shaft, a second expandable member, and a side hole, the second delivery catheter comprising: The stent includes a first portion and a second portion, wherein the first portion is crimped uniformly on the second expandable member, the second portion being the second expandable member. And being crimped onto the combination comprising the first shaft;
At least partially expanding the second expandable member, thereby at least partially expanding the second portion of the second stent;
At least one of slidably advancing or retracting the first shaft through the side hole under the second portion of the second stent, whereby the first stent A shaft slides over the first portion of the second stent;
Including a method.
(Item 50)
50. The method of item 49, further comprising expanding the second expandable member to deploy the second stent within a body lumen.
(Item 51)
Slidably retracting the first shaft relative to the deployed second stent, thereby deploying the first stent adjacent to the second stent. 51. A method according to item 50, wherein the first expandable member is installed to do so.
(Item 52)
52. The item 51, further comprising expanding the first expandable member to deploy the first stent in a body lumen adjacent to the second stent. Method.
The present invention relates to methods of use, methods of manufacture, and delivery systems used to deliver stents in branch vessels. Embodiments may be configured to stent a portion of the mother vessel and a portion of the daughter vessel.

  Accordingly, in a first aspect, a method for crimping a stent on an expandable member of a delivery catheter is disclosed. The method includes placing a stent having a first portion and a second portion over the expandable member and crimping the stent non-uniformly to the expandable member. The stent includes a sidewall having a side hole therethrough. In many embodiments, the first portion is crimped uniformly to the expandable member and the second portion is crimped non-uniformly to the expandable member. The first portion of the stent can be crimped uniformly circumferentially and longitudinally along it. The second portion of the stent can be crimped non-uniformly circumferentially along it. The first portion of the stent can be disposed more distally than the second portion of the stent. The first portion can be disposed distal to the side holes and the second portion can be disposed proximal to the side holes. The first portion of the stent can be crimped using a contraction port.

  In a preferred embodiment, the at least one stent has a sidewall having a side hole or opening therethrough, and a portion of the delivery catheter may pass through the side hole. However, this is not intended to be limiting and, in any of the embodiments disclosed herein, one of ordinary skill in the art may have a different exit point for the stent. Will recognize. Thus, the delivery catheter may pass through the exit point whether it is a side hole in the side wall of the stent or placed in another part of the stent.

  The method can be practiced to produce a stent that is securely crimped to an expandable member. For example, a stent can include a sidewall having a plurality of openings therethrough. The expandable member can protrude at least partially into one or more of the openings. The method can include partially inflating the expandable member prior to or during crimping. For example, the expandable member can be inflated during crimping to a pressure in the range of about 50 psi to about 100 psi. The method can include heating at least one of the expandable member or stent prior to and / or during crimping. For example, the at least one expandable member or stent can be heated to a temperature in the range of about 50 degrees Celsius to about 65 degrees Celsius.

  The method can include steps accomplished to check for leaks after crimping. For example, the method can include applying a vacuum pressure to the expandable member and checking for leaks while the vacuum pressure is applied to the expandable member. The method can include at least partially inflating the expandable member and checking for leakage while the expandable member is at least partially inflated.

  In many embodiments, the second portion of the stent is crimped to accommodate an elongate shaft beneath it. For example, the method crimps the second portion of the stent such that the second portion of the stent is partially crimped to the expandable member so that it is not crimped onto the expandable member over the portion of the expandable member. Steps may be included. The method can include partially crimping the second portion to the expandable member to allow slidable movement of the elongate shaft thereunder. The first portion and the second portion can be crimped while still allowing the elongate shaft to slidably pass through the side holes. The second portion of the stent can be crimped using a shrink port.

  The method can be practiced to produce a stent in which the second portion is partially secured to the expandable member. For example, the second portion of the stent can include a sidewall having a plurality of apertures therethrough, and the expandable member can protrude at least partially into one or more of the apertures. it can. The method can include heating at least one of the expandable member or the second portion of the stent prior to and / or during the crimping of the second portion of the stent. For example, the at least one expandable member or second portion of the stent can be heated to a temperature in the range of about 50 degrees Celsius to about 65 degrees Celsius.

  In many embodiments, the method includes sending an elongate shaft through a side hole under the second portion of the stent for delivery outside the first portion. In such embodiments, the crimping of the second portion of the stent includes placing a spacer between a portion of the elongate shaft and a portion of the second portion of the stent; Crimping a portion of the second portion of the device and removing the spacer, wherein the elongate shaft is slidably disposed relative to the second portion of the stent prior to deployment of the stent. Steps. The spacer can include a protective sheath. The method can include partially inflating the expandable member prior to and / or during crimping of the second portion of the stent. Crimping the second portion of the stent can include crimping a portion of the second portion of the stent in contact with the elongate shaft. In embodiments where a portion of the second portion of the stent is crimped in contact with the elongate shaft, the elongate shaft can be slidably disposed relative to the second portion of the stent after deployment of the stent. it can. A portion of the second portion can be crimped to a portion of the expandable member.

  The stent can be coated with a therapeutic agent. For example, the stent can be coated with a therapeutic agent that prevents restenosis.

  In another aspect, a device for treating a bifurcated body lumen is disclosed. The device is disposed on the first elongate shaft having a proximal end and a distal end, a first expandable member adjacent to the distal end of the first elongate shaft, and the first expandable member. A first delivery catheter comprising a first radially expandable stent. The first stent includes a sidewall having a side hole therethrough. The first stent has a folded configuration and an expanded configuration. In the collapsed configuration, the first stent is coupled with the first expandable member. And in the expanded configuration, the first stent supports the vessel wall. The first stent is crimped non-uniformly to the first expandable member.

  In many embodiments, the first stent includes a first portion and a second portion. The second portion of the first stent can crimp non-uniformly to the first expandable member. For example, the annular passage connected to the side hole is oriented along the second portion of the first stent and disposed between the second portion of the first stent and the first expandable member. be able to. The first portion of the first stent can be disposed more distally than the second portion of the first stent.

  The first portion of the first stent can be crimped securely to the expandable member. For example, the first portion of the first stent can include a sidewall having a plurality of openings therethrough, and the expandable member protrudes at least partially into one or more of the openings. Can do.

  The first stent can be coated with a therapeutic agent. For example, the first stent can be coated with a therapeutic agent that prevents restenosis.

  In many embodiments, the device for treating a bifurcated body lumen further includes a second delivery catheter. A second delivery catheter includes a second elongate shaft having a proximal end and a distal end, a second expandable member adjacent the distal end of the second elongate shaft, and a second expandable member. And a second radially expandable stent disposed thereon. The second stent has a folded configuration and an expanded configuration. In the collapsed configuration, the stent is uniformly crimped to the second expandable member. In the expanded configuration, the second stent supports the vessel wall. A portion of the second delivery catheter passes through the annular passage and the side hole of the first stent.

  In various ways, the first and second delivery catheters can be independent of each other. For example, the first expandable member and the second expandable member can be expandable independently of each other. The second delivery catheter can be slidable axially relative to the first delivery catheter when the first stent is in a collapsed configuration. The second delivery catheter can also be crimped onto the second delivery catheter. The second delivery catheter can then be slidable axially relative to the first delivery catheter when the first stent is in the expanded configuration.

  The second stent can be coated with a therapeutic agent. For example, the second stent can be coated with a therapeutic agent that prevents restenosis.

  In another aspect, a method for treating bifurcation is disclosed. The method includes providing a first delivery catheter having a first shaft, a first expandable member, and a first stent crimped over the first expandable member; and a second shaft Providing a second delivery catheter having a second expandable member, and a second stent having a side hole, wherein the second stent is uniformly over the second expandable member. A first portion to be crimped, and a second portion to be crimped partially over the second expandable member; and a first shaft of the first portion of the stent that is crimped uniformly. Slidably advancing the first shaft out of the side hole under the partially crimped second portion of the stent to slide up.

  In many embodiments, the method includes deploying one or more of the first and second stents. For example, the method can include expanding the second expandable member to deploy the second stent into the body lumen. The method slidably moves the first shaft relative to the deployed second stent so as to install the first expandable member and deploy the first stent adjacent to the second stent. A step of retracting can be included. The method can include expanding the first expandable member to deploy the first stent into the body lumen adjacent to the second stent.

  In another aspect, a method for treating bifurcation is disclosed. The method includes providing a first delivery catheter having a first shaft, a first expandable member, and a first stent crimped over the first expandable member; and a second shaft Providing a second delivery catheter having a second expandable member, and a second stent having a side hole, wherein the second stent is uniformly over the second expandable member. A step having a first portion to be crimped and a second portion to be partially crimped on the second expandable member, thereby at least partially expanding the second expandable member, thereby At least partially expanding the second portion of the second stent; and second of the second stent so that the first shaft slides over the first portion of the second stent. Through the side hole under the part of Te, and at least one of steps to steps or backward to advance the first shaft slidably.

  In many embodiments, the method includes deploying one or more of the first and second stents. For example, the method can include expanding the second expandable member to deploy the second stent into the body lumen. The method slidably moves the first shaft relative to the deployed second stent so as to install the first expandable member and deploy the first stent adjacent to the second stent. A step of retracting can be included. The method can include expanding the first expandable member to deploy the first stent into the body lumen adjacent to the second stent.

  These and other embodiments are described in further detail in the following description related to the accompanying drawings.

1A-1B illustrate an exemplary embodiment of a system having an over-the-wire mother catheter and a rapid exchange daughter catheter. 2A-2B illustrate an exemplary embodiment of a system having an over-the-wire daughter catheter and a rapid exchange mother catheter. 3A-3B illustrate an exemplary embodiment of a system having a rapid exchange mother catheter and a rapid exchange daughter catheter. 4A-4B illustrate an exemplary embodiment of a system having an over-the-wire mother catheter and an over-the-wire daughter catheter. 5A-5B illustrate another exemplary embodiment of a system having a capture tube, an over-the-wire mother catheter, and a rapid exchange daughter catheter. 6A-6B illustrate another exemplary embodiment of a system having a capture tube, an over-the-wire daughter catheter, and a rapid exchange mother catheter. 7A-7B illustrate another exemplary embodiment of a system having a capture tube, a rapid exchange mother catheter, and a rapid exchange daughter catheter. 8A-8B illustrate another exemplary embodiment of a system having a capture tube, an over-the-wire mother catheter, and an over-the-wire daughter catheter. 9A-9B illustrate yet another exemplary embodiment of a system having a removable capture tube, an over-the-wire mother catheter, and a rapid exchange daughter catheter. 10A-10B illustrate yet another exemplary embodiment of a system having a removable capture tube, an over-the-wire daughter catheter, and a rapid exchange mother catheter. 11A-11B illustrate yet another exemplary embodiment of a system having a removable capture tube, a rapid exchange mother catheter, and a rapid exchange daughter catheter. 12A-12B illustrate yet another exemplary embodiment of a system having a removable capture tube, an over-the-wire mother catheter, and an over-the-wire daughter catheter. 13A-13C illustrate yet another exemplary embodiment of a system having a snap fitting, an over-the-wire mother catheter, and a rapid exchange daughter catheter. 14A-14C illustrate yet another exemplary embodiment of a system having a snap fitting, an over-the-wire daughter catheter, and a rapid exchange mother catheter. FIGS. 15A-15B illustrate yet another exemplary embodiment of a system having a snap fitting, a rapid exchange mother catheter, and a rapid exchange daughter catheter. 16A-16C illustrate yet another exemplary embodiment of a system having a snap fitting, an over-the-wire mother catheter, and an over-the-wire daughter catheter. 17A-17C illustrate another exemplary embodiment of a system having a snap fitting, an over-the-wire mother catheter, and a rapid exchange daughter catheter. 18A-18C illustrate another exemplary embodiment of a system having a snap fitting, an over-the-wire daughter catheter, and a rapid exchange mother catheter. 19A-19C illustrate another exemplary embodiment of a system having a snap fitting, a rapid exchange mother catheter, and a rapid exchange daughter catheter. 20A-20C illustrate another exemplary embodiment of a system having a snap fitting, an over-the-wire mother catheter, and an over-the-wire daughter catheter. 21A-21B illustrate yet another exemplary embodiment of a system having an over-the-wire mother catheter and a rapid exchange daughter catheter. 22A-22B illustrate yet another exemplary embodiment of a system having an over-the-wire daughter catheter and a rapid exchange mother catheter. 23A-23B illustrate yet another exemplary embodiment of a system having a rapid exchange mother catheter and a rapid exchange daughter catheter. Figures 24A-24B illustrate yet another exemplary embodiment of a system having an over-the-wire mother catheter and an over-the-wire daughter catheter. Figures 25A-25B, 26A-26B, 27A-27B, 28A-28B, 29A-29B, and 30A-30B illustrate exemplary methods of treating bifurcation. Figures 25A-25B, 26A-26B, 27A-27B, 28A-28B, 29A-29B, and 30A-30B illustrate exemplary methods of treating bifurcation. Figures 25A-25B, 26A-26B, 27A-27B, 28A-28B, 29A-29B, and 30A-30B illustrate exemplary methods of treating bifurcation. Figures 25A-25B, 26A-26B, 27A-27B, 28A-28B, 29A-29B, and 30A-30B illustrate exemplary methods of treating bifurcation. Figures 25A-25B, 26A-26B, 27A-27B, 28A-28B, 29A-29B, and 30A-30B illustrate exemplary methods of treating bifurcation. Figures 25A-25B, 26A-26B, 27A-27B, 28A-28B, 29A-29B, and 30A-30B illustrate exemplary methods of treating bifurcation. FIG. 31 illustrates an exemplary embodiment of a stent. FIG. 32 illustrates an exemplary embodiment of a system having a mother catheter and a daughter catheter. FIG. 33 highlights the distal portion of the system illustrated in FIG. FIG. 34 illustrates the alignment of the stents of FIGS. 32-33. FIG. 35A illustrates an exemplary embodiment of a delivery catheter having an elongated shaft and an expandable member. FIG. 35B illustrates an exemplary embodiment of an uncrimped stent including a side wall with a side hole therethrough. FIG. 35C illustrates an elongate shaft of a delivery catheter delivered through a side hole in an uncrimped stent sidewall, according to many embodiments. FIG. 35D illustrates the combination of FIG. 35C with another delivery catheter expandable member installed in an uncrimped stent with side holes, according to many embodiments. 35E and 35F schematically illustrate cross sections AA and BB of FIG. 35D, respectively. 35E and 35F schematically illustrate cross sections AA and BB of FIG. 35D, respectively. FIGS. 35G-35J schematically illustrate a crimp of a portion of the stent of FIG. 35D disposed distal to the side hole, according to many embodiments. FIGS. 35G-35J schematically illustrate a crimp of a portion of the stent of FIG. 35D disposed distal to the side hole, according to many embodiments. FIGS. 35G-35J schematically illustrate a crimp of a portion of the stent of FIG. 35D disposed distal to the side hole, according to many embodiments. FIGS. 35G-35J schematically illustrate a crimp of a portion of the stent of FIG. 35D disposed distal to the side hole, according to many embodiments. FIGS. 35K through 35N schematically illustrate a crimp of a portion of the stent of FIG. 35D disposed proximal to a side hole, according to many embodiments. FIGS. 35K through 35N schematically illustrate a crimp of a portion of the stent of FIG. 35D disposed proximal to a side hole, according to many embodiments. FIGS. 35K through 35N schematically illustrate a crimp of a portion of the stent of FIG. 35D disposed proximal to a side hole, according to many embodiments. FIGS. 35K through 35N schematically illustrate a crimp of a portion of the stent of FIG. 35D disposed proximal to a side hole, according to many embodiments. FIG. 35O schematically illustrates a combined crimp configuration including a mother and daughter delivery catheter and stent, according to many embodiments. FIG. 35P schematically illustrates a cross-section through a mother stent crimped over a combination including a mother expandable member and a daughter delivery catheter elongate shaft, according to many embodiments. FIG. 35Q illustrates an alternative embodiment of a stent crimp. FIG. 36 illustrates a stent placed over the mother and daughter catheters. FIG. 37 illustrates a stent placed over the mother and daughter catheters and a stent placed over the daughter catheter. 38A-38M illustrate an exemplary method of treating a bifurcation. 38A-38M illustrate an exemplary method of treating a bifurcation. 38A-38M illustrate an exemplary method of treating a bifurcation. 38A-38M illustrate an exemplary method of treating a bifurcation. 38A-38M illustrate an exemplary method of treating a bifurcation. 38A-38M illustrate an exemplary method of treating a bifurcation. 38A-38M illustrate an exemplary method of treating a bifurcation. 38A-38M illustrate an exemplary method of treating a bifurcation. 38A-38M illustrate an exemplary method of treating a bifurcation. 38A-38M illustrate an exemplary method of treating a bifurcation. 38A-38M illustrate an exemplary method of treating a bifurcation. 38A-38M illustrate an exemplary method of treating a bifurcation. 38A-38M illustrate an exemplary method of treating a bifurcation. Figures 39A-39M illustrate another exemplary method of treating a bifurcation. Figures 39A-39M illustrate another exemplary method of treating a bifurcation. Figures 39A-39M illustrate another exemplary method of treating a bifurcation. Figures 39A-39M illustrate another exemplary method of treating a bifurcation. Figures 39A-39M illustrate another exemplary method of treating a bifurcation. Figures 39A-39M illustrate another exemplary method of treating a bifurcation. Figures 39A-39M illustrate another exemplary method of treating a bifurcation. Figures 39A-39M illustrate another exemplary method of treating a bifurcation. Figures 39A-39M illustrate another exemplary method of treating a bifurcation. Figures 39A-39M illustrate another exemplary method of treating a bifurcation. Figures 39A-39M illustrate another exemplary method of treating a bifurcation. Figures 39A-39M illustrate another exemplary method of treating a bifurcation. Figures 39A-39M illustrate another exemplary method of treating a bifurcation. 40A-40H illustrate various stents that may be used with the systems and methods disclosed herein to treat bifurcations. 40A-40H illustrate various stents that may be used with the systems and methods disclosed herein to treat bifurcations. 40A-40H illustrate various stents that may be used with the systems and methods disclosed herein to treat bifurcations. 40A-40H illustrate various stents that may be used with the systems and methods disclosed herein to treat bifurcations. 40A-40H illustrate various stents that may be used with the systems and methods disclosed herein to treat bifurcations. 40A-40H illustrate various stents that may be used with the systems and methods disclosed herein to treat bifurcations. 40A-40H illustrate various stents that may be used with the systems and methods disclosed herein to treat bifurcations. 40A-40H illustrate various stents that may be used with the systems and methods disclosed herein to treat bifurcations. 41A-41B illustrate an exemplary embodiment of a balloon configuration. 42A-42C illustrate the engagement of the side branch stent with the main branch stent. 43A-43B illustrate another configuration of a side branch stent that engages a main branch stent. 44-46 illustrate yet another configuration of side branch stent engagement with the main branch stent. 44-46 illustrate yet another configuration of side branch stent engagement with the main branch stent. 44-46 illustrate yet another configuration of side branch stent engagement with the main branch stent. 47A-47D illustrate the interfit of a side branch stent and a main branch stent. FIG. 48 illustrates another exemplary balloon catheter.

  The present invention relates to a delivery system for delivering a stent to a vessel branch having a main branch and a side branch, and is generally configured to at least partially cover a portion of the side branch and a portion of the main branch. However, this is not intended to be limiting and those skilled in the art will recognize that the devices and methods disclosed herein may be used to treat other areas of the body. You will recognize.

  The scientific community is slowly moving away from main branch versus side branch models and nomenclature. It is now widely accepted that the “mother” blood vessel branches into two “daughter blood vessels”, two blood vessels that are anatomically after the protuberance. A blood vessel that appears to be a continuation of the mother vessel is usually less angular. The other blood vessel is often smaller in diameter and may be commonly referred to as a side branch or daughter vessel. Thus, herein, the terms “main branch”, “stem”, or “mother vessel” may be used interchangeably. Also, herein, “side branch vessels” and “daughter vessels” vessels can also be used interchangeably. The terms “main branch stent”, “trunk stent” or “mother stent” and the term “side branch stent” are also interchangeable with “daughter stent”. If the main branch vessel branches into two equally sized branches, one of the branches may still be considered the main branch or mother vessel and the other branch may be considered the side branch or daughter vessel .

  Various catheter designs may be employed to deploy and install the mother and daughter stents. Such catheters may be used in connection with multiple guidewires that terminate in the mother and daughter vessels. These guidewires may be used to facilitate the introduction of a catheter, any angioplasty balloon, any stent, and / or to properly orient the stent or balloon within the vessel.

  In general, the methods disclosed herein utilize a catheter system comprising a catheter body having a mother vessel guidewire lumen and a daughter vessel balloon that is independently operable and coupled to the catheter body. May be. The daughter balloon catheter portion has a daughter blood vessel guidewire lumen. The catheter system further includes a mother catheter balloon, and the stent is disposed on the balloon. The daughter catheter portion extends into the proximal opening of the mother stent and exits from the mother stent through the side passage of the mother stent.

  According to one method, the mother vessel guidewire is inserted into the mother vessel until the distal end of the mother vessel guidewire crosses the daughter vessel mouth, and the daughter vessel guidewire is inserted into the daughter vessel at the distal end of the daughter vessel guidewire. It is inserted into the mother vessel until it enters the vessel. In order to prevent crossing of the guide wires, the two blood vessels are tied together through a guide wire catheter having two lumens in order to separate the guide wires and prevent them from becoming entangled.

  The wire separator is then placed over the wire so that the guide wire catheter is removed and the guide wire remains open. The catheter system is then advanced over the mother and daughter vascular guidewires, and the mother and daughter vascular catheters pass over the mother and daughter vascular guidewires. The catheter system is distal over the mother balloon catheter portion and is advanced over both wires with the daughter vessel balloon catheter portion leading to the system. As the catheter system is advanced over the wire, the daughter vessel balloon may enter the daughter vessel and be placed after or simultaneously with the placement of the mother vessel balloon. The mother balloon catheter portion of the catheter system is then advanced distally as long as it can be advanced to the extent that it is stopped by the bulge. It cannot be advanced beyond the bifurcation site because the tension of the daughter catheter to the mother stent prevents the mother catheter from moving distally. At this time, the distal portion of the mother stent is beyond the ridge in the mother vessel and cannot be advanced further. This method facilitates advancement of the catheter system relative to the bifurcation, which may be necessary for tortuous or calcified coronary arteries. Once the catheter system is in place, the daughter vessel balloon catheter portion is pulled back with respect to the mother catheter so that the proximal portion of the daughter balloon is partially within the mother stent. An alignment can be made using radiopaque markers in that the proximal markers on the two balloons are next to each other. The operator can then gradually push the catheter system distally to maximize juxtaposition to the ridge. The daughter balloon, partially under the mother stent, is then inflated to ensure proper alignment of the mother stent. The daughter balloon may have a stent on its distal portion, resulting in the simultaneous expansion of the mother stent and the proximal portion of the daughter stent. The daughter balloon is then deflated.

  The mother balloon is then inflated to deploy the mother stent. Contact of the two balloons, reinflation is performed if necessary or to transfer the plaque. The catheter system may be removed while the wire remains in place. In this embodiment, or any of the other embodiments disclosed herein, angioplasty catheters may be used to pre-dilate blood vessels and lesions prior to stent placement. In some embodiments, primary stent placement is employed where the stent is deployed without pre-expansion. The two blood vessels may be vascularized separately if pre-dilation is occasionally indicated.

  In an alternative method, the mother catheter can be placed on the daughter vessel guidewire and the daughter catheter can be placed on the mother vessel guidewire. In a daughter vessel with a high slope, for example, when the bifurcation angle is greater than about 60-70 °, the daughter stent is pulled into the mother stent along the side branch, as opposed to the previous configuration, between the catheters. Friction is lower when the operator needs to pull the daughter stent proximally along the main branch into the mother stent. As the catheter system is advanced, the daughter balloon catheter connects to the system and passes through the daughter vessel mouth while remaining in the mother vessel. As the catheter system is further advanced, the mother balloon catheter enters the daughter vessel. The catheter system can only be advanced a distance towards the bifurcation until it is stopped by the bulge. It cannot be advanced beyond the bifurcation site because the tension of the daughter catheter to the mother stent prevents the mother catheter from moving distally. At this time, the distal portion of the mother stent is beyond the daughter vessel opening and cannot be advanced further. While the mother catheter is carried in place, the daughter catheter is pulled back so that the proximal portion of the daughter balloon is partially within the mother stent. An alignment can be made using radiopaque markers in that the proximal markers on the two balloons are next to each other. The operator can then gradually push the catheter system distally to maximize juxtaposition to the ridge. When the daughter balloon is inflated, the stent on the daughter balloon (partially under the mother stent) is positioned so that the proximal portion of the daughter stent and the mother stent expands simultaneously and completely covers the mother vessel. Be aligned. 0} The daughter vessel balloon is then deflated. The mother vessel balloon is then inflated and the distal portion of the mother stent is expanded. If necessary, a contact procedure can be performed.

  If necessary, the mother blood vessel can be stented using a commercially available stent. A balloon on the wire can be used as an alternative to the daughter catheter. In an alternative embodiment, the catheter system can be deployed with a daughter balloon portion proximal to the mother balloon portion and advanced to the bifurcation on the guidewire. In the case of a mother catheter on the mother guidewire, the tension between the daughter guidewire and the mother stent on the mother catheter prevents further advancement of the mother catheter, resulting in alignment between the mother stent and the daughter vessel opening. In an alternative case of the mother catheter on the daughter guide wire, the tension between the mother guide wire and the mother stent on the mother catheter (or on the daughter guide wire) prevents further advancement of the mother catheter, so And alignment with the mother ostium occur. In both cases, the daughter stent is advanced and expanded in line with the mother stent. In a preferred embodiment, the mother catheter is an over-the-wire (OTW) design and the daughter catheter is preferably a rapid exchange (RX) design with a daughter catheter portion distal to it. The daughter balloon is placed just distal to the tip of the mother catheter, and this arrangement minimizes the overall profile of the catheter system and allows maximum tracking of the artery. The system may additionally have a stent crimped over the balloon. The daughter stent may be of any length, but in a preferred embodiment is about half the length of the daughter balloon or mother stent. The proximal end of the mother stent is only slightly crimped to allow the daughter catheter balloon portion to operate independently so that it can be pushed or pulled without removing the mother stent. Also good.

The exemplary method includes the following steps.
1. The catheter system is advanced to the branch in each vessel, the daughter balloon catheter portion, and the mother balloon catheter portion.
2. The tension between the mother stent and the daughter catheter prevents the mother catheter from being advanced. 3. The daughter balloon proximal portion is pulled back into the mother stent and aligned with the radiopaque marker.
4). The operator pushes slightly forward while holding both the mother and daughter catheters firmly.
5. When the daughter balloon is inflated and the daughter stent is expanded, about half of the distal portion of the daughter balloon expands the “half stent” and half of the proximal portion of the daughter balloon expands inside the mother vessel, Partially expand the proximal portion. Expansion of the proximal portion of the mother and daughter stents preferably occurs simultaneously.
6). Once the daughter stent is fully deployed, the mother balloon can then be fully expanded to deploy the distal portion of the mother stent.
7). Conventional contact procedures may be used to ensure complete juxtaposition. In one particular aspect, the daughter balloon catheter portion may be used without a stent. This allows perfect alignment of the mother stent around the daughter vessel opening. The daughter balloon is used for alignment, as outlined in step 3 above, to expand the proximal portion of the mother stent.

In an alternative embodiment, the mother catheter is an over-the-wire (OTW) design and the daughter catheter is a rapid exchange (RX) design with a daughter catheter portion distal to it. The system may additionally have a stent crimped over the balloon. The daughter stent is preferably smaller than the length of the mother balloon or stent, but this is not intended to be limiting and the daughter stent may be of any length. The proximal end of the mother stent is independent of the daughter catheter balloon portion so that it can be pushed or pulled without removing or affecting the mother stent without constraints and minimal friction. May be partially crimped to allow it to operate. The exemplary method includes the following steps.
1. Loop the OTW so that one operator can grasp both guidewires with one hand and then push both catheters with the other hand.
2. As disclosed in steps 2 through 3 of the above embodiment, the catheter system is advanced into the bifurcated, daughter balloon catheter portion, and mother balloon catheter portion aligned within the respective blood vessels.
3. While firmly holding both the mother and daughter catheters, push the catheter system forward until the mother balloon catheter portion is stopped at the ridge.
4). When the daughter balloon is inflated and the daughter stent is expanded, about half of the distal portion of the daughter balloon expands the “half stent” and half of the proximal portion of the daughter balloon expands inside the mother vessel, Partially expand the proximal portion.
5. Once the daughter stent is fully deployed, the mother balloon can then be fully expanded to deploy the distal portion of the mother stent.
6). Conventional contact procedures may be used to ensure complete juxtaposition.

  In one particular aspect, the daughter balloon catheter portion may be used without a stent. This allows perfect alignment of the mother stent around the daughter vessel opening. The daughter balloon is used for alignment, as outlined in step 3 above, to expand the proximal portion of the mother stent.

In an alternative embodiment, the mother catheter is an over-the-wire design and the daughter catheter is a quick-exchange design with the daughter catheter portion distal to it. The system may additionally have a stent crimped over the balloon. The daughter stent may preferably be about half the length of the mother balloon or stent, but this is not intended to be limiting and the daughter stent may be of any length . The proximal end of the mother stent is partially crimped to allow the daughter catheter balloon portion to operate independently so that it can be pushed or pulled without removing the mother stent. Also good. The exemplary method includes the following steps.
1. A daughter catheter is placed over the guide wire in the daughter vessel, and the system is slid into the guide catheter without placing a mother balloon over the guide wire. After the leading daughter catheter enters the coronary artery and immediately before the mother catheter exits the guide catheter, the mother guidewire is inserted through the mother catheter into the mother vessel and then over the two guidewires from the guide catheter Extrude the system. This method reduces wire wrapping.
2. The catheter system is advanced into the bifurcation, daughter balloon catheter portion, and mother balloon catheter portion, aligned within each vessel.
3. As disclosed in step 2 of the above embodiment, the catheter system is advanced into the bifurcated, daughter balloon catheter portion, and mother balloon catheter portion aligned within the respective blood vessels. Pull the daughter catheter back until the proximal markers on both balloons are aligned.
4). When the daughter balloon is inflated and the daughter stent is expanded, about half of the distal portion of the daughter balloon expands the “half stent” and half of the proximal portion of the daughter balloon expands inside the mother vessel, Partially expand the proximal portion.
5. Once the daughter stent is fully deployed, the mother balloon can then be fully expanded to deploy the distal portion of the mother stent.
6). Conventional contact procedures may be used to ensure complete juxtaposition. In one particular aspect, the daughter balloon catheter portion may be used without a stent. This allows perfect alignment of the mother stent around the daughter vessel opening. The daughter balloon is used for alignment, as outlined in step 3 above, to expand the proximal portion of the mother stent.

  In an alternative implementation, the mother and daughter system balloons are aligned. This embodiment can include a mother and / or daughter stent. When there is both a mother stent and a daughter stent, the daughter stent is preferably shorter than the mother stent, but may be any length, and in a preferred embodiment, the daughter stent is attached to the distal half of the daughter balloon. It is about half the length of the mother stent so that it can be placed on top. In addition, the proximal portion of the daughter catheter shaft is placed under the non-uniformly crimped mother stent. The double stent arrangement reduces the profile compared to a full length stent that covers the entire length of the daughter balloon.

  The methods described herein may alternatively include flushing the catheter and guidewire port to aid operability. The methods described herein may alternatively include two snap-on coupler steps that lock the two catheters together. In another specific aspect, each balloon catheter portion may include at least one radiopaque marker. Using such a configuration, the marker separation is such that the balloon catheter portion crosses the vessel opening and the daughter balloon catheter portion enters the daughter vessel, thus aligning the stent passage with the daughter vessel opening. It may be conveniently observed using fluoroscopy. In another particular aspect, the hybrid version is preferred because the catheter system design is considered to cover a combination of rapid exchange and over-the-wire, and is easy to distinguish while using fluoroscopy for visualization purposes.

  In another particular aspect, the proximal balloon may be specifically expandable, such that one end of the balloon may expand before the other. In another specific aspect, the proximal balloon catheter portion may receive a stent that can be crimped under various pressures to allow freedom of movement to the distal balloon catheter portion.

  In another specific aspect, the stent may be crimped over the proximal balloon catheter portion, and the stent may be designed to be deployed in various configurations to better counter the patient's anatomy.

  In another specific aspect, the distal balloon catheter portion may be delivered via a pull-away or exfoliated capture tube. All of the above embodiments preferably have a mother vessel stent having any diameter, having a diameter ranging from about 2.5 to about 5 millimeters, and preferably any diameter ranging from about 2 to about 5 millimeters. A daughter vessel stent may be utilized. The length of the stent may be any length, preferably in the range of about 4-40 millimeters. The position of the stent on the catheter need not be fixed and may be placed on either or both catheters.

(Catheter configuration)
FIG. 1A illustrates an exemplary embodiment of a catheter system 100 having a distal daughter balloon catheter portion comprising a balloon having a daughter stent crimped thereon. The daughter stent may be shorter than the mother stent, and in this embodiment, as well as any other embodiment disclosed herein, may not be centered on its corresponding balloon. Thus, in a preferred embodiment, as will be discussed in more detail below, the proximal portion of the daughter balloon remains uncovered by the stent. In certain embodiments, the daughter stent is preferably about half the length of the mother stent. The distal daughter stent is crimped under standard conditions known in the art. The proximal mother balloon catheter portion comprises a mother balloon and a mother stent. The mother stent is specifically crimped along the longitudinal direction and in the circumferential direction. In this exemplary embodiment, the distal half of the mother stent is crimped under typical conditions to ensure that the mother stent is not removed during alignment with the distal daughter balloon. In addition, despite the fact that a portion of the daughter balloon catheter portion is circumferentially enclosed, the proximal portion of the mother stent is non-standard to allow freedom of movement to the distal daughter balloon catheter portion. Crimped under relatively loose conditions. Mother-daughter catheters are slidably attached to each other through a hollow exchange port. The exchange port is implanted on the mother side over the wire catheter and has an internal diameter that is large enough to allow insertion of a rapid exchange daughter catheter and balloon. The exchange port may be of any length extending between the proximal portion of the balloon and the distal portion of the catheter connector, and in this embodiment is about 10 centimeters in length, although the preferred implementation The form varies from about 1 centimeter to about 30 centimeters, and in a more preferred embodiment is from about 5 cm to about 10 cm in length. The inlet for the daughter catheter on the exchange port is proximal and the outlet for the daughter catheter is on the distal end of the exchange port. The daughter catheter is mounted through the exchange port, and the daughter balloon preferably extends approximately 5 cm distal from the exit of the exchange port. However, it is possible to have the exchange port at any distance from the mother balloon, but preferably about 1 to about 30 centimeters proximal to the mother balloon. The daughter stent can be crimped onto the balloon after being loaded through the exchange port. The exchange port preferably fits tightly to reduce the catheter profile and preferably has low friction to allow the operator to easily slide the catheter relative to each other.

  FIG. 1B more clearly illustrates the features of the catheter system 100 of FIG. 1A. Stent delivery system 100 includes a first catheter 102 and a second catheter 130. The first catheter 102 includes an elongate shaft 104 having a radially expandable balloon 106 disposed near the distal end of the elongate shaft 104. A stent 108 having a proximal portion 122, a distal portion 114, and a side hole 120 is disposed on the balloon 106. The distal portion 114 is crimped to the balloon 106 to prevent release during delivery, while the proximal portion 122 allows the second catheter 130 to slide under the proximal portion 122 of the stent 108. The balloon 106 is partially crimped so that it can be advanced or retracted. The first catheter extends from a distal guidewire port 110 at the distal end of the elongate shaft 104 to a proximal end of the elongate shaft 104 into a Y-shaped adapter 114 having a connector 116. Is an over-the-wire (OTW) catheter. The connector 116 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 112 exits through connector 116. Also preferably, the second connector 118, which is a luer connector, provides an inflator or other device to the catheter for inflation of the balloon 106 through an inflation lumen (not shown) in the elongate shaft 104. Enables installation. The first catheter 102 also includes a hollow exchange port tube 124 connected to the elongate shaft 104. The hollow exchange port tube 124 may be coextruded with the first shaft 104 or may be coupled thereto or otherwise attached using techniques known to those skilled in the art. The hollow exchange port may alternatively be coupled with the other shaft 132. The hollow exchange port tube 124 includes a central channel 126 extending therethrough and is sized to slidably receive a portion of the second catheter 130. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 104, often near the balloon 106 and / or stent 108.

  Second catheter 130 includes an elongate shaft 132 having a radially expandable balloon 140 disposed near the distal end of elongate shaft 132. The stent 142 is placed on the balloon 140. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 142 is shorter than the working length of the balloon 140 such that the proximal portion of the balloon 140 is not constrained by the stent 142, and this unconstrained portion of the balloon 140 will be discussed below. In addition, the side hole 120 may be slidably advanced or retracted under the proximal portion 122 of the stent 108. Stent 142 is crimped to balloon 140 to prevent release during delivery. At least a portion of the balloon 140 and the stent 142 are offset distally relative to the balloon 106 and the stent 108 to minimize the device profile. In this embodiment, the distal stent 142 may be deployed in the main branch of the blood vessel and the other stent 108 may be deployed in the side branch of the blood vessel. Alternatively, the distal stent 142 may be deployed in the side branch of the blood vessel and the other stent 108 may be deployed in the main branch of the blood vessel. The second catheter 130 extends from a distal guidewire port 138 at the distal end of the elongate shaft 132 to a proximal guidewire port 136 that is closer to the distal port 138 than to the proximal end of the catheter shaft 132. A rapid exchange catheter (RX) having a wire lumen 134. Proximal guidewire port 136 is also unobstructed by hollow exchange tube 124 and is preferably more proximal. Preferably, the connector 144, which is a luer connector, is connected to the proximal end of the elongate shaft 132 so that an indeflator or other device can be used to inflate the balloon 140 with an inflation lumen (not shown) in the elongate shaft 132. ). A portion of the shaft 132 is disposed in the central channel 126 of the hollow exchange tube 124, which helps to keep the two catheter shafts 104, 132 parallel, during delivery and when the shaft 132 is relative to the shaft 104. To prevent tangling when it is slidably advanced or retracted. Also, another portion of the shaft 132 is disposed below the proximal portion 122 of the stent 108. The second catheter 130 may also be slidably advanced or retracted under the proximal portion 122 of the stent 108 such that the shaft 132 passes through the side hole 120 of the stent 108. To help mark the proximal and distal ends of the stent or balloon, and to facilitate alignment of the two catheters during stent deployment, as discussed elsewhere herein, X Radiopaque markers may be placed at various locations along the shaft 132, often near the balloon 140 and / or the stent 142.

  FIG. 2A illustrates a cross-sectional view of one embodiment of a catheter system having a daughter catheter balloon portion distal to the mother balloon portion that utilizes the same exchange port as described in FIG. 1A. The mother balloon is preferably at least about 5 cm distal from the exit of the exchange port. As disclosed above, the mother balloon may be about 1 cm to 30 cm distal from the exchange port.

  FIG. 2B more clearly illustrates the features of the catheter system 200 of FIG. 2A. Stent delivery system 200 includes a first catheter 202 and a second catheter 230. The first catheter 202 includes an elongate shaft 204 having a radially expandable balloon 206 disposed near the distal end of the elongate shaft 204 and a stent 208 disposed on the balloon 206. The stent 208 may be the same length as the working length of the balloon 208 or may be shorter. In a preferred embodiment, the stent 208 is shorter than the working length of the balloon 206 so that the proximal portion of the balloon 206 remains unconstrained by the stent 208. The proximal portion of the balloon 206 can be slidably advanced or retracted under the stent 242 through the side hole 220. Stent 208 is crimped to balloon 206 to prevent release during delivery. The first catheter extends from a distal guidewire port 210 at the distal end of the elongate shaft 204 to a proximal end of the elongate shaft 204 into a Y-shaped adapter 214 having a connector 216. Is an over-the-wire (OTW) catheter. The connector 216 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, the guidewire lumen 212 exits through the connector 216. Also preferably, the second connector 218, which is a luer connector, is an inflator or other device to the catheter for inflation of the balloon 206 through an inflation lumen (not shown) in the elongate shaft 204. Enables mounting. The first catheter 202 also includes a hollow exchange port tube 224 connected to the elongate shaft 204. The hollow exchange port tube 224 may be co-extruded with the first shaft 204 or may be coupled thereto or otherwise attached using techniques known to those skilled in the art. The hollow exchange port may alternatively be coupled with the other shaft 232. The hollow exchange port tube 224 includes a central channel 226 extending therethrough and is sized to slidably receive a portion of the second catheter 230. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 204, often near the balloon 206 and / or the stent 208.

  The second catheter 230 includes an elongate shaft 232 having a radially expandable balloon 240 disposed near the distal end of the elongate shaft 232. A stent 242 having a proximal portion 222, a distal portion 214, and a side hole 220 is disposed on the balloon 240. Since the distal portion 214 is crimped to the balloon 240 to prevent release during delivery, the proximal portion 222 is partially crimped to the balloon 240 so that the elongate shaft 204 is proximate to the stent 242. It can be slidably advanced or retracted under the position portion 222. The stent may preferably have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. At least a portion of the balloon 206 and the stent 208 are offset distally relative to the balloon 240 and the stent 242 to minimize the device profile. In this embodiment, the distal stent 208 may be deployed in the main branch of the blood vessel and the other stent 242 may be deployed in the side branch of the blood vessel. Alternatively, the distal stent 208 may be deployed in the side branch of the blood vessel and the other stent 242 may be deployed in the main branch of the blood vessel. The second catheter 230 extends from a distal guidewire port 238 at the distal end of the elongate shaft 232 to a proximal guidewire port 236 that is closer to the distal port 238 than to the proximal end of the catheter shaft 232. A rapid exchange catheter (RX) having a wire lumen 234. Proximal guidewire port 236 is also unobstructed by hollow exchange tube 224 and is preferably more proximal thereto. Preferably, the connector 244, which is a luer connector, is connected to the proximal end of the elongate shaft 232 and an indeflator or other device is connected to the inflation lumen (not shown) in the elongate shaft 232 for inflation of the balloon 240. ). A portion of the shaft 232 is disposed in the central channel 226 of the hollow exchange tube 224, which helps to keep the two catheter shafts 204, 232 parallel, during delivery and the shaft 232 relative to the shaft 204. To prevent tangling when it is slidably advanced or retracted. Also, a portion of the shaft 204 is disposed below the proximal portion 222 of the stent 242. The first catheter 202 can be slidably advanced or retracted under the proximal portion 222 of the stent 242 such that the shaft 204 passes through the side hole 220 of the stent 242. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 232, often near the balloon 240 and / or the stent 242.

  FIG. 3A illustrates a cross-sectional view of one embodiment of a catheter system 300 having a mother and daughter catheter, both having a rapid exchange design. In this particular embodiment, one of the catheters has a hollow exchange port embedded in its side and the other catheter is mounted through the exchange port. Typically, the catheter is loaded prior to crimping the stent over the balloon portion.

  FIG. 3B more clearly illustrates the features of the catheter system 300 of FIG. 3A. Stent delivery system 300 includes a first catheter 302 and a second catheter 330. The first catheter 302 includes an elongate shaft 304 having a radially expandable balloon 306 disposed near the distal end of the elongate shaft 304. A stent 308 having a proximal portion 322, a distal portion 314, and a side hole 320 is disposed over the balloon 306. Since the distal portion 314 is crimped to the balloon 306 to prevent release during delivery, the proximal portion 322 is partially crimped to the balloon 306 so that the second catheter 330 can be Can be slidably advanced or retracted under the proximal portion 322 of the. The first catheter extends from a distal guidewire port 310 at the distal end of the elongate shaft 304 to a proximal guidewire port 311 that is closer to the distal port 310 than to the proximal end of the catheter shaft 304. A rapid exchange catheter (RX) having a lumen 312. Connector 316 is coupled to the proximal end of elongate shaft 304. The connector 316 is preferably a luer connector, which allows easy connection with an indeflator or other device for inflation of the balloon 306. The first catheter 302 also includes a hollow exchange port tube 324 connected to an elongate shaft 304. The hollow exchange port tube 324 may be coextruded with the first shaft 304 or may be coupled thereto or otherwise attached using techniques known to those skilled in the art. The hollow exchange port may alternatively be coupled with the other shaft 332. The hollow exchange port tube 324 includes a central channel 326 extending therethrough and is sized to slidably receive a portion of the second catheter 330. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 304, often near the balloon 306 and / or the stent 308.

  Second catheter 330 includes an elongate shaft 332 having a radially expandable balloon 340 disposed near the distal end of elongate shaft 332. Stent 342 is placed over balloon 340. The stent may have a length that matches the working length of the balloon, or the stent may be shorter than the working length of the balloon. In a preferred embodiment, the stent 342 is shorter than the working length of the balloon 340 so that the proximal portion of the balloon 340 is not constrained by the stent 342, and this unconstrained portion of the balloon 340 will be discussed below. And can be slidably advanced or retracted under the proximal portion 322 of the stent 308 through the side hole 320. Stent 342 is crimped to balloon 340 to prevent release during delivery. At least a portion of balloon 340 and stent 342 are offset distally relative to balloon 306 and stent 308 to minimize the device profile. In this embodiment, the distal stent 342 may be deployed in the main branch of the vessel and the other stent 308 may be deployed in the side branch of the vessel. Alternatively, the distal stent 342 may be deployed in the side branch of the blood vessel and the other stent 308 may be deployed in the main branch of the blood vessel. The second catheter 330 extends from a distal guidewire port 338 at the distal end of the elongate shaft 332 to a proximal guidewire port 336 that is closer to the distal port 338 than to the proximal end of the catheter shaft 332. A rapid exchange catheter (RX) having a wire lumen 334. Proximal guidewire port 336 is also unobstructed by hollow exchange tube 324 and may be distal to it. Preferably, the connector 344, which is a luer connector, is connected to the proximal end of the elongate shaft 332 so that an indeflator or other device can be inflated in the elongate shaft 332 (not shown) for inflation of the balloon 340. ). A portion of the shaft 332 is disposed within the central channel 326 of the hollow exchange tube 324, which helps keep the two catheter shafts 304, 332 parallel, during delivery and the shaft 332 is relative to the shaft 304. To prevent tangling when it is slidably advanced or retracted. Also, another portion of shaft 332 is disposed under proximal portion 322 of stent 308. The second catheter 330 can also be slidably advanced or retracted under the proximal portion 322 of the stent 308 such that the shaft 332 passes through the side hole 320 of the stent 308. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 332, often near the balloon 340 or the stent 342.

  FIG. 4A illustrates a cross-sectional view of one embodiment of a catheter system 400 having a mother and daughter catheter both having an over-the-wire design. In this particular embodiment, one of the catheters has a hollow exchange port embedded in its side and the other catheter does not have a hollow exchange port. A catheter without an exchange port is mounted on a catheter having an exchange port. Typically, the catheter needs to be loaded before crimping the stent over the balloon portion.

  FIG. 4B more clearly illustrates the features of the catheter system 400 of FIG. 4A. Stent delivery system 400 includes a first catheter 402 and a second catheter 430. The first catheter 402 includes an elongate shaft 404 having a radially expandable balloon 406 disposed near the distal end of the elongate shaft 404. A stent 408 having a proximal portion 422, a distal portion 414, and a side hole 420 is disposed over the balloon 406. Since distal portion 414 is crimped to balloon 406 to prevent release during delivery, proximal portion 422 is partially crimped to balloon 406 so that second catheter 430 is stent 408. Can be slidably advanced or retracted under the proximal portion 422 of the. The first catheter extends from a distal guidewire port 410 at the distal end of the elongate shaft 404 to a proximal end of the elongate shaft 404 and into a Y-shaped adapter 414 having a connector 416. An over-the-wire (OTW) catheter. The connector 416 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, the guidewire lumen 412 exits through the connector 416. Also preferably, the second connector 418, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 406 through an inflation lumen (not shown) in the elongate shaft 404. Enables mounting. The first catheter 402 also includes a hollow exchange port tube 424 connected to the elongate shaft 404. The hollow exchange port tube 424 may be coextruded with the first shaft 404, or may be coupled thereto or otherwise attached using techniques known to those skilled in the art. The hollow exchange port may alternatively be coupled with the other shaft 432. The hollow exchange port tube 424 includes a central channel 426 extending therethrough and is sized to slidably receive a portion of the second catheter 430. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 404, often near the balloon 406 and / or the stent 408.

  Second catheter 430 includes an elongate shaft 432 having a radially expandable balloon 440 disposed near the distal end of elongate shaft 432. Stent 442 is placed over balloon 440. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 442 is shorter than the working length of the balloon 440 so that the proximal portion of the balloon 440 is not constrained by the stent 442, and this unconstrained portion of the balloon 440 will be discussed below. And can be slidably advanced or retracted through the side hole 420 under the proximal portion 422 of the stent 408. Stent 442 is crimped to balloon 440 to prevent release during delivery. At least a portion of the balloon 440 and the stent 442 are offset distally with respect to the balloon 406 and the stent 408 to minimize the device profile. In this embodiment, the distal stent 442 may be deployed in the main branch of the vessel and the other stent 408 may be deployed in the side branch of the vessel. Alternatively, the distal stent 442 may be deployed in the side branch of the blood vessel and the other stent 408 may be deployed in the main branch of the blood vessel. A second catheter 430 extends from a distal guidewire port 438 at the distal end of the elongate shaft 432 to a proximal end of the elongate shaft 432 and into a Y-shaped adapter 446 having a connector 448. 434, an over-the-wire (OTW) catheter. The connector 448 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 434 exits through connector 448. Also preferably, the second connector 444, which is a luer connector, provides an inflator or other device to the catheter for inflation of the balloon 440 through an inflation lumen (not shown) in the elongate shaft 432. Enables mounting. A portion of the shaft 432 is disposed in the central channel 426 of the hollow exchange tube 424, which helps to keep the two catheter shafts 404, 432 parallel, during delivery and when the shaft 432 is relative to the shaft 404. To prevent tangling when it is slidably advanced or retracted. Also, another portion of shaft 432 is disposed under proximal portion 422 of stent 408. The second catheter 430 can also be slidably advanced or retracted under the proximal portion 422 of the stent 408 such that the shaft 432 passes through the side hole 420 of the stent 408. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 432, often near the balloon 440 or the stent 442.

  Figures 5A, 6A, 7A, and 8A illustrate end-to-end capture tubes connecting catheters together. The capture tube prevents the catheter from becoming entangled. The capture tube preferably remains in place during the entire clinical procedure. In these exemplary embodiments, the capture tube is from about 10 centimeters distal to the indeflator attachment to about 10 centimeters proximal from the proximal rapid exchange port of the rapid exchange catheter. Up to a thin polymer hollow straw covering the mother and daughter catheters.

  FIG. 5A illustrates a catheter system 500 having a distal daughter catheter having a rapid exchange configuration and a proximal mother catheter having an over-the-wire configuration. FIG. 5B more clearly illustrates the features of the catheter system 500 seen in FIG. 5A. Stent delivery system 500 includes a first catheter 502 and a second catheter 530. The first catheter 502 includes an elongate shaft 504 having a radially expandable balloon 506 disposed near the distal end of the elongate shaft 504. A stent 508 having a proximal portion 522, a distal portion 514, and a side hole 520 is disposed over the balloon 506. Since distal portion 514 is crimped to balloon 506 to prevent release during delivery, proximal portion 522 is partially crimped to balloon 506 so that second catheter 530 is stent 508. Can be slidably advanced or retracted under the proximal portion 522 of the. The first catheter extends from a distal guidewire port 510 at the distal end of the elongate shaft 504 to a proximal end of the elongate shaft 504 into a Y-shaped adapter 514 having a connector 516. An over-the-wire (OTW) catheter. The connector 516 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 512 exits through connector 516. Also preferably, the second connector 518, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 506 through an inflation lumen (not shown) in the elongate shaft 504. Enables mounting. The first catheter 502 is disposed in the central channel 526 of the capture tube 524. The center channel 526 is sized to fit both shafts 504, 532 and allow their slidable movement. The shaft 504 is slidable within the central channel 526 or may be locked using a locking collar 525 such as a Tuohy-Borst compression fitting. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 504, often near the balloon 506 and / or the stent 508.

  Second catheter 530 includes an elongate shaft 532 having a radially expandable balloon 540 disposed near the distal end of elongate shaft 532. Stent 542 is placed over balloon 540. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 542 is shorter than the working length of the balloon 540 so that the proximal portion of the balloon 540 is not constrained by the stent 542, and this unconstrained portion of the balloon 540 will be discussed below. And can be slidably advanced or retracted through the side hole 520 under the proximal portion 522 of the stent 508. Stent 542 is crimped to balloon 540 to prevent release during delivery. At least a portion of balloon 540 and stent 542 are offset distally relative to balloon 506 and stent 508 to minimize the device profile. In this embodiment, the distal stent 542 may be deployed in the main branch of the vessel and the other stent 508 may be deployed in the side branch of the vessel. Alternatively, the distal stent 542 may be deployed in the side branch of the blood vessel and the other stent 508 may be deployed in the main branch of the blood vessel. The second catheter 530 extends from a distal guidewire port 538 at the distal end of the elongate shaft 532 to a proximal guidewire port 536 that is closer to the distal port 538 than the proximal end of the catheter shaft 532. A rapid exchange catheter (RX) having a wire lumen 534. The proximal guidewire port 536 is also unobstructed by the capture tube 524 and may be more distal. A connector 544, preferably a luer connector, is connected to the proximal end of the elongate shaft 532 so that an inflator or other device can be used to inflate the balloon 540 with an inflation lumen (not shown) in the elongate shaft 532. ). A portion of the shaft 532 is disposed in the central channel 526 of the capture tube 524, which helps to keep the two catheter shafts 504, 532 parallel, during delivery and the shaft 532 is in the central channel 526. To prevent tangling when it is slidably advanced. A compression fitting 525 may be used to lock the elongate shafts 504, 532 into the capture tube 524 to prevent axial movement. The compression fixture may be a Tuohy-Borst fixture. Also, another portion of the shaft 532 is disposed below the proximal portion 522 of the stent 508. The second catheter 530 can also be slidably advanced or retracted under the proximal portion 522 of the stent 508 such that the shaft 532 passes through the side hole 520 of the stent 508. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 532, often near the balloon 540 or stent 542.

  FIG. 6A illustrates a catheter system 600 having a distal daughter catheter having an over-the-wire configuration and a proximal mother catheter having a rapid exchange configuration. FIG. 6B more clearly illustrates the features of the catheter system 600 seen in FIG. 6A. Stent delivery system 600 includes a first catheter 602 and a second catheter 630. The first catheter 602 includes an elongate shaft 604 having a radially expandable balloon 606 disposed near the distal end of the elongate shaft 604 and a stent 608 disposed on the balloon 606. The stent 608 may be the same length as the working length of the balloon 608 or may be shorter. In a preferred embodiment, the stent 608 is shorter than the working length of the balloon 606 so that the proximal portion of the balloon 606 remains unconstrained by the stent 608. The proximal portion of the balloon 606 can be slidably advanced or retracted under the stent 642 via the side hole 620. Stent 608 is crimped to balloon 606 to prevent release during delivery. The first catheter extends from a distal guidewire port 610 at the distal end of the elongate shaft 604 to a proximal end of the elongate shaft 604 and into a Y-shaped adapter 614 having a connector 616. An over-the-wire (OTW) catheter. The connector 616 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, the guidewire lumen 612 exits through the connector 616. Also preferably, the second connector 618, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 606 through an inflation lumen (not shown) in the elongate shaft 604. Enables mounting. The first catheter 602 is disposed in the central channel 626 of the capture tube 624. The central channel 626 is sized to fit both shafts 604, 632 and allow their slidable movement. The shaft 604 is slidable within the central channel 626 or may be locked using a locking collar 525 such as a Tuohy-Borst compression fitting. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 604, often near the balloon 606 and / or the stent 608.

  Second catheter 630 includes an elongate shaft 632 having a radially expandable balloon 640 disposed near the distal end of elongate shaft 632. A stent 642 having a proximal portion 622, a distal portion 614, and a side hole 620 is disposed over the balloon 640. Since the distal portion 614 is crimped to the balloon 640 to prevent release during delivery, the proximal portion 622 is partially crimped to the balloon 640 so that the elongate shaft 604 is proximate to the stent 642. It can be slidably advanced or retracted under the position portion 622. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. At least a portion of the balloon 606 and the stent 608 are offset distally relative to the balloon 640 and the stent 642 to minimize the device profile. In this embodiment, the distal stent 608 may be deployed in the main branch of the vessel and the other stent 642 may be deployed in the side branch of the vessel. Alternatively, the distal stent 608 may be deployed in the side branch of the blood vessel and the other stent 642 may be deployed in the main branch of the blood vessel. The second catheter 630 extends from a distal guidewire port 638 at the distal end of the elongate shaft 632 to a proximal guidewire port 636 that is closer to the distal port 638 than the proximal end of the catheter shaft 632. A rapid exchange catheter (RX) having a wire lumen 634. Proximal guidewire port 636 is also unobstructed by capture tube 624 and may be distal to it. Preferably, a connector 644, which is a luer connector, is connected to the proximal end of the elongate shaft 632 and an inflator or other device is connected to an inflation lumen (not shown) in the elongate shaft 632 for inflation of the balloon 640. ). A portion of the shaft 632 is placed in the central channel 626 of the capture tube 624, which helps keep the two catheter shafts 604, 632 parallel, during delivery and the shaft 604 is in the central channel 626. To prevent tangling when it is slidably advanced. A compression fitting 625 may be used to lock the elongated shafts 604, 632 in the capture tube 624 to prevent axial movement. The compression fixture may be a Tuohy-Borst fixture. Also, a portion of the shaft 604 is disposed under the proximal portion 622 of the stent 642. The first catheter 602 can be slidably advanced or retracted under the proximal portion 622 of the stent 642 such that the shaft 604 passes through the side hole 620 of the stent 642. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 632, often near the balloon 640 or the stent 642.

  Since FIG. 7A shows a catheter system 700 having a double rapid exchange mother and daughter catheter, the capture tube endpoint is preferably about 10 centimeters proximal from the rapid exchange port on the distal most catheter. is there. FIG. 7B more clearly illustrates the features of the catheter system 700 seen in FIG. 7A. Stent delivery system 700 includes a first catheter 702 and a second catheter 730. The first catheter 702 includes an elongate shaft 704 having a radially expandable balloon 706 disposed near the distal end of the elongate shaft 704. A stent 708 having a proximal portion 722, a distal portion 714, and a side hole 720 is disposed over the balloon 706. Since distal portion 714 is crimped to balloon 706 to prevent release during delivery, proximal portion 722 is partially crimped to balloon 706 so that second catheter 730 is stent 708. Can be slidably advanced or retracted under the proximal portion 722 of the. The first catheter extends from a distal guidewire port 710 at the distal end of the elongate shaft 704 to a proximal guidewire port 711 closer to the distal port 710 than to the proximal end of the catheter shaft 704. A rapid exchange catheter (RX) having a lumen 712. Connector 716 is coupled to the proximal end of elongate shaft 704. The connector 716 is preferably a luer connector, which allows easy connection with an indeflator or other device for inflation of the balloon 706. The first catheter 702 is disposed in the central channel 726 of the capture tube 724. The central channel 726 is sized to fit both shafts 704, 732 and allow their slidable movement. The shaft 704 is slidable within the central channel 726 or may be locked using a locking collar 725 such as a Tuohy-Borst compression fitting. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 704, often near the balloon 706 and / or the stent 708.

  The second catheter 730 includes an elongate shaft 732 having a radially expandable balloon 740 s disposed near the distal end of the elongate shaft 732. Stent 742 is placed over balloon 740. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 742 is shorter than the working length of the balloon 740 so that the proximal portion of the balloon 740 is not constrained by the stent 742, and this unconstrained portion of the balloon 740 will be discussed below. And can be slidably advanced or retracted through the side hole 720 and under the proximal portion 722 of the stent 708. Stent 742 is crimped to balloon 740 to prevent release during delivery. At least a portion of balloon 740 and stent 742 are offset distally relative to balloon 706 and stent 708 to minimize the device profile. In this embodiment, the distal stent 742 may be deployed in the main branch of the vessel and the other stent 708 may be deployed in the side branch of the vessel. Alternatively, the distal stent 742 may be deployed in the side branch of the blood vessel and the other stent 708 may be deployed in the main branch of the blood vessel. The second catheter 730 extends from a distal guidewire port 738 at the distal end of the elongate shaft 732 to a proximal guidewire port 736 closer to the distal port 738 than to the proximal end of the catheter shaft 732. A rapid exchange catheter (RX) having a wire lumen 734. Proximal guidewire port 736 is also unobstructed by capture tube 724 and may be distal to it. Preferably, a connector 744, which is a luer connector, is connected to the proximal end of the elongate shaft 732 and an indeflator or other device is connected to the inflation lumen (not shown) in the elongate shaft 732 for inflation of the balloon 740. ). A portion of the shaft 732 is placed in the central channel 726 of the capture tube 724, which helps to keep the two catheter shafts 704, 732 parallel, during delivery and the shaft 732 is in the central channel 726. To prevent tangling when it is slidably advanced. A compression fitting 725 may be used to lock the elongate shafts 704, 732 into the capture tube 724 to prevent axial movement. The compression fixture may be a Tuohy-Borst fixture. Also, another portion of shaft 732 is disposed under proximal portion 722 of stent 708. The second catheter 730 can also be slidably advanced or retracted under the proximal portion 722 of the stent 708 such that the shaft 732 passes through the side hole 720 of the stent 708. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 732, often near the balloon 740 or the stent 742.

  FIG. 8A embodies a catheter system 800 having an over-the-wire design, so that the end of the capture tube preferably terminates approximately 30 centimeters proximal from the balloon portion of the most distal catheter. FIG. 8B more clearly illustrates the features of the catheter system 800 of FIG. 8A. Stent delivery system 800 includes a first catheter 802 and a second catheter 830. The first catheter 802 includes an elongate shaft 704 having a radially expandable balloon 806 disposed near the distal end of the elongate shaft 804. A stent 808 having a proximal portion 822, a distal portion 814, and a side hole 820 is disposed over the balloon 806. Because the distal portion 814 is crimped to the balloon 806 to prevent release during delivery, the proximal portion 822 is partially crimped to the balloon 806 so that the second catheter 830 is stent 808. Can be slidably advanced or retracted under the proximal portion 822 of the. The first catheter extends from a distal guidewire port 810 at the distal end of the elongate shaft 804 to a proximal end of the elongate shaft 804 and into a Y-shaped adapter 814 having a connector 816. An over-the-wire (OTW) catheter. The connector 816 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 812 exits through connector 816. Also preferably, the second connector 818, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 806 via an inflation lumen (not shown) in the elongate shaft 804. Enables mounting. The first catheter 802 is disposed in the central channel 826 of the capture tube 824. The center channel 826 is sized to fit both shafts 804, 832 and allow their slidable movement. The shaft 804 is slidable within the central channel 826 or may be locked using a locking collar 825 such as a Tuohy-Borst compression fitting. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 804, often near the balloon 806 and / or the stent 808.

  Second catheter 830 includes an elongate shaft 832 having a radially expandable balloon 840 disposed near the distal end of elongate shaft 832. Stent 842 is placed over balloon 840. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 842 is shorter than the working length of the balloon 840 so that the proximal portion of the balloon 840 is not constrained by the stent 842, and this unconstrained portion of the balloon 840 will be discussed below. And can be slidably advanced or retracted through the side hole 820 under the proximal portion 822 of the stent 808. Stent 842 is crimped to balloon 840 to prevent release during delivery. At least a portion of balloon 840 and stent 842 are offset distally relative to balloon 806 and stent 808 to minimize the device profile. In this embodiment, the distal stent 842 may be deployed in the main branch of the vessel and the other stent 808 may be deployed in the side branch of the vessel. Alternatively, the distal stent 842 may be deployed in the side branch of the blood vessel and the other stent 808 may be deployed in the main branch of the blood vessel. A second catheter 830 extends from a distal guidewire port 838 at the distal end of the elongate shaft 832 to a proximal end of the elongate shaft 832 into a Y-shaped adapter 846 having a connector 848. Over-the-wire (OTW) catheter with 834. The connector 848 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 834 exits through connector 848. Also preferably, the second connector 844, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 840 through an inflation lumen (not shown) in the elongate shaft 832. Enables mounting. A portion of the shaft 832 is placed in the central channel 826 of the capture tube 824, which helps to keep the two catheter shafts 804, 832 parallel, during delivery and the shaft 832 is in the central channel 826. To prevent tangling when it is slidably advanced. A compression fitting 825 may be used to lock the elongate shafts 804, 832 in the capture tube 824 to prevent axial movement. The compression fixture may be a Tuohy-Borst fixture. Also, another portion of the shaft 832 is disposed under the proximal portion 822 of the stent 808. The second catheter 830 can also be slidably advanced or retracted under the proximal portion 822 of the stent 808 such that the shaft 832 passes through the side hole 820 of the stent 808. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 832, often near the balloon 840 or the stent 842.

  9A, 10A, 11A, and 12A illustrate a removable capture tube that fits over a dual catheter as described above, but the capture tube has a polymer adduct. Once the operator places the catheter system near the bifurcation, the operator can grasp the polymer appendage and pull the catheter capture tube apart.

  FIG. 9A illustrates a catheter system 900 having a distal daughter catheter having a rapid exchange configuration and a proximal mother catheter having an over-the-wire configuration. FIG. 9B more clearly illustrates the features of the catheter system 900 seen in FIG. 9A. Stent delivery system 900 includes a first catheter 902 and a second catheter 930. The first catheter 902 includes an elongate shaft 904 having a radially expandable balloon 906 disposed near the distal end of the elongate shaft 904. A stent 908 having a proximal portion 922, a distal portion 914, and a side hole 920 is disposed over the balloon 906. Since distal portion 914 is crimped to balloon 906 to prevent release during delivery, proximal portion 922 is partially crimped to balloon 906 so that second catheter 930 is stent 908. Can be slidably advanced or retracted under the proximal portion 922 of the. The first catheter extends from a distal guidewire port 910 at the distal end of the elongate shaft 904 to a proximal end of the elongate shaft 904 into a Y-shaped adapter 914 having a connector 916. An over-the-wire (OTW) catheter. The connector 916 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, the guidewire lumen 912 exits through the connector 916. Also preferably, the second connector 918, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 906 through an inflation lumen (not shown) in the elongate shaft 904. Enables mounting. The first catheter 902 is disposed in the central channel 926 of the capture tube 924 having a perforated region 945 along its longitudinal length. The center channel 926 is sized to fit both shafts 904, 932 and allow their slidable movement. The shaft 904 is slidable in the central channel 926 or may be locked using a locking collar 925 such as a Tuohy-Borst compression fitting. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 904, often near the balloon 906 and / or the stent 908. A perforated region 945 along the capture tube 924 allows the capture tube to be easily detached from both shafts 904, 932 once the catheter is properly installed and no longer needed.

  Second catheter 930 includes an elongate shaft 932 having a radially expandable balloon 940 disposed near the distal end of elongate shaft 932. Stent 942 is placed over balloon 940. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 942 is shorter than the working length of the balloon 940 so that the proximal portion of the balloon 940 is not constrained by the stent 942, and this unconstrained portion of the balloon 940 will be discussed below. And can be slidably advanced or retracted under the proximal portion 922 of the stent 908 through the side hole 920. Stent 942 is crimped to balloon 940 to prevent release during delivery. At least a portion of the balloon 940 and the stent 942 are offset distally relative to the balloon 906 and the stent 908 to minimize the device profile. In this embodiment, the distal stent 942 may be deployed in the main branch of the vessel and the other stent 908 may be deployed in the side branch of the vessel. Alternatively, the distal stent 942 may be deployed in the side branch of the blood vessel and the other stent 908 may be deployed in the main branch of the blood vessel. The second catheter 930 extends from a distal guidewire port 938 at the distal end of the elongate shaft 932 to a proximal guidewire port 936 that is closer to the distal port 938 than the proximal end of the catheter shaft 932. A rapid exchange catheter (RX) having a wire lumen 934. The proximal guidewire port 936 is also unobstructed by the capture tube 924 and may be distal to it. A connector 944, preferably a luer connector, is connected to the proximal end of the elongate shaft 932 so that an indeflator or other device can be used to inflate the balloon 940 with an inflation lumen (not shown) in the elongate shaft 932. ). A portion of the shaft 932 is placed in the central channel 926 of the capture tube 924, which helps keep the two catheter shafts 904, 932 parallel, during delivery and the shaft 932 is in the central channel 926. To prevent tangling when it is slidably advanced. A compression fitting 925 may be used to lock the elongate shafts 904, 932 in the capture tube 924 to prevent axial movement. The compression fixture may be a Tuohy-Borst fixture. Also, another portion of shaft 932 is disposed under proximal portion 922 of stent 908. The second catheter 930 can also be slidably advanced or retracted under the proximal portion 922 of the stent 908 such that the shaft 932 passes through the side hole 920 of the stent 908. Capture tube 924 may be peeled from shaft 932 by cutting perforated region 945. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 932, often near the balloon 940 or stent 942.

  FIG. 10A illustrates a catheter system 1000 having a distal daughter catheter having an over-the-wire design and a proximal mother catheter having a rapid exchange design. FIG. 10B more clearly illustrates the features of the catheter system 1000 seen in FIG. 10A. Stent delivery system 1000 includes a first catheter 1002 and a second catheter 1030. First catheter 1002 includes an elongated shaft 1004 having a radially expandable balloon 1006 disposed near the distal end of elongated shaft 1004 and a stent 1008 disposed on balloon 1006. The stent 1008 may be the same length as the working length of the balloon 1008 or may be shorter. In a preferred embodiment, the stent 1008 is shorter than the working length of the balloon 1006 so that the proximal portion of the balloon 1006 remains unconstrained by the stent 1008. The proximal portion of the balloon 1006 can be slidably advanced or retracted under the stent 1042 via the side hole 1020. Stent 1008 is crimped to balloon 1006 to prevent release during delivery. The first catheter extends from a distal guidewire port 1010 at the distal end of the elongate shaft 1004 to a proximal end of the elongate shaft 1004 into a Y-shaped adapter 1014 having a connector 1016 and a guidewire lumen 1012. An over-the-wire (OTW) catheter. The connector 1016 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, the guidewire lumen 1012 exits through the connector 1016. Also preferably, the second connector 1018, which is a luer connector, is an inflator or other device to the catheter for inflation of the balloon 1006 through an inflation lumen (not shown) in the elongate shaft 1004. Enables mounting. The first catheter 1002 is disposed in the central channel 1026 of the capture tube 1024 having a perforated region 1045 along its longitudinal length. The central channel 1026 is sized to fit both shafts 1004, 1032 and allow their slidable movement. The shaft 1004 is slidable in the central channel 1026 or may be locked using a locking collar 1025 such as a Tuohy-Borst compression fitting. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1004, often near the balloon 1006 and / or the stent 1008. The perforated region 1045 along the capture tube 1024 allows the capture tube to be easily detached from both shafts 1004, 1032 once the catheter is properly installed and is no longer needed.

  Second catheter 1030 includes an elongate shaft 1032 having a radially expandable balloon 1040 disposed near the distal end of elongate shaft 1032. A stent 1042 having a proximal portion 1022, a distal portion 1014, and a side hole 1020 is disposed over the balloon 1040. Since the distal portion 1014 is crimped to the balloon 1040 to prevent release during delivery, the proximal portion 1022 is partially crimped to the balloon 1040 so that the elongate shaft 1004 is proximate to the stent 1042. It can be slidably advanced or retracted under the positioning portion 1022. The stent may preferably have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. At least a portion of the balloon 1006 and the stent 1008 are offset distally relative to the balloon 1040 and the stent 1042 to minimize the device profile. In this embodiment, the distal stent 1008 may be deployed in the main branch of the vessel and the other stent 1042 may be deployed in the side branch of the vessel. Alternatively, the distal stent 1008 may be deployed in the side branch of the blood vessel and the other stent 1042 may be deployed in the main branch of the blood vessel. The second catheter 1030 extends from a distal guidewire port 1038 at the distal end of the elongate shaft 1032 to a proximal guidewire port 1036 that is closer to the distal port 1038 than to the proximal end of the catheter shaft 1032. A rapid exchange catheter (RX) having a wire lumen 1034. Proximal guidewire port 1036 is also unobstructed by capture tube 1024 and may be distal to it. Preferably, the connector 1044, which is a luer connector, is connected to the proximal end of the elongate shaft 1004 "so that an inflator or other device is inflated in the elongate shaft 1032 (not shown) for inflation of the balloon 1040. A portion of the shaft 1032 is placed in the central channel 1026 of the capture tube 1024, which helps to keep the two catheter shafts 1004, 1032 parallel and delivery And entangles the shaft 1032 as it is slidably advanced in the central channel 1026. A compression fitting 1025 locks the elongated shaft 1004, 1032 into the capture tube 1024. And may be used to prevent axial movement. It may also be an ohy-Borst attachment, and a portion of the shaft 1032 is disposed below the proximal portion 1022 of the stent 1042. The first catheter 1002 has the shaft 1004 passing through the side hole 1020 of the stent 1042. As it passes, it can be slidably advanced or retracted under the proximal portion 1022 of the stent 1042. The capture tube 1024 may be detached from the shaft 1032 by cutting the perforated region 1045. The stent or To help mark the proximal and distal ends of the balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, A permeable marker is often placed near the balloon 1040 or stent 1042 on the shaft. It may be located at various positions along the 032.

  FIG. 11A illustrates a catheter system 1100 having a dual rapid exchange design with a removable capture tube. FIG. 11B more clearly illustrates the features of the catheter system 1100 of FIG. 11A. Stent delivery system 1100 includes a first catheter 1102 and a second catheter 1130. First catheter 1102 includes an elongate shaft 1104 having a radially expandable balloon 1106 disposed near the distal end of elongate shaft 1104. A stent 1108 having a proximal portion 1122, a distal portion 1114, and a side hole 1120 is disposed over the balloon 1106. Since the distal portion 1114 is crimped to the balloon 1106 to prevent release during delivery, the proximal portion 1122 is partially crimped to the balloon 1106 so that the second catheter 1130 is a stent 1108. May be slidably advanced under the proximal portion 1122. The first catheter extends from a distal guidewire port 1110 at the distal end of the elongate shaft 1104 to a proximal guidewire port 1111 that is closer to the distal port 1110 than to the proximal end of the catheter shaft 1104. A rapid exchange catheter (RX) having a lumen 1112. Connector 1116 is coupled to the proximal end of elongate shaft 1104. The connector 1116 is preferably a luer connector, which allows easy connection with an indeflator or other device for inflation of the balloon 1106. The first catheter 1102 is disposed in the central channel 1126 of the capture tube 1124 having a perforated region 1145. The central channel 1126 is sized to fit both shafts 1104, 1132 and allow their slidable movement. The shaft 1104 is slidable within the central channel 1126 or may be locked using a locking collar 1125 such as a Tuohy-Borst compression fitting. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1104, often near the balloon 1106 and / or the stent 1108. The perforated region 1145 along the capture tube 1124 allows the capture tube to be easily detached from both catheter shafts 1104, 1132 once the catheter is properly installed and is no longer needed. .

  The second catheter 1130 includes an elongate shaft 1132 having a radially expandable balloon 1140 disposed near the distal end of the elongate shaft 1132. Stent 1142 is placed over balloon 1140. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 1142 is shorter than the working length of the balloon 1140 so that the proximal portion of the balloon 1140 is not constrained by the stent 1142, and this unconstrained portion of the balloon 1140 will be discussed below. And can be slidably advanced or retracted through the side hole 1120 under the proximal portion 1122 of the stent 1108. Stent 1142 is crimped to balloon 1140 to prevent release during delivery. At least a portion of the balloon 1140 and the stent 1142 are offset distally relative to the balloon 1106 and the stent 1108 to minimize the device profile. In this embodiment, the distal stent 1142 may be deployed in the main branch of the vessel and the other stent 1108 may be deployed in the side branch of the vessel. Alternatively, the distal stent 1142 may be deployed in the side branch of the blood vessel and the other stent 1108 may be deployed in the main branch of the blood vessel. The second catheter 1130 extends from a distal guidewire port 1138 at the distal end of the elongate shaft 1132 to a proximal guidewire port 1136 that is closer to the distal port 1138 than to the proximal end of the catheter shaft 1132. A rapid exchange catheter (RX) having a wire lumen 1134. Proximal guidewire port 1136 is also unobstructed by capture tube 1124 and may be distal to it. Preferably, a connector 1144, which is a luer connector, is connected to the proximal end of the elongate shaft 1132 so that an indeflator or other device can be inflated in the elongate shaft 1132 for inflation of the balloon 1140 (not shown). ). A portion of the shaft 1132 is placed in the central channel 1126 of the capture tube 1124, which helps to keep the two catheter shafts 1104, 1132 parallel, during delivery and the shaft 1132 is in the central channel 1126. To prevent tangling when it is slidably advanced. A compression fitting 1125 may be used to lock the elongated shaft 1104, 1132 within the capture tube 1124 to prevent axial movement. The compression fixture may be a Tuohy-Borst fixture. Also, a portion of the shaft 1132 is disposed below the proximal portion 1122 of the stent 1108. The second catheter 1130 can also be slidably advanced or retracted under the proximal portion 1122 of the stent 1108 such that the shaft 1132 passes through the side hole 1120 of the stent 1108. Capture tube 1124 may be peeled from shaft 1132 by cutting perforated region 1145. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1132, often near the balloon 1140 or the stent 1142.

  FIG. 12A illustrates a catheter system 1200 having a dual over-the-wire design with a removable capture tube. FIG. 12B more clearly illustrates the features of the catheter system 1200 of FIG. 12A. Stent delivery system 1200 includes a first catheter 1202 and a second catheter 1230. First catheter 1202 includes an elongate shaft 1204 having a radially expandable balloon 1206 disposed near the distal end of elongate shaft 1204. A stent 1208 having a proximal portion 1222, a distal portion 1214, and a side hole 1220 is disposed over the balloon 1206. Since distal portion 1214 is crimped to balloon 1206 to prevent release during delivery, proximal portion 1222 is partially crimped to balloon 1206 so that second catheter 1230 is stent 1208. Can be slidably advanced under the proximal portion 1222. The first catheter extends from a distal guidewire port 1210 at the distal end of the elongate shaft 1204 to a proximal end of the elongate shaft 1204 and into a Y-shaped adapter 1214 having a connector 1216. An over-the-wire (OTW) catheter. The connector 1216 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 1212 exits through connector 1216. Also preferably, the second connector 1218, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 1206 via an inflation lumen (not shown) in the elongate shaft 1204. Enables mounting. The first catheter 1202 is disposed in the central channel 1226 of the capture tube 1224 having a perforated region 1245. The central channel 1226 is sized to fit both shafts 1204, 1232 and allow their slidable movement. The shaft 1204 is slidable within the central channel 1226 or may be locked using a locking collar 1225 such as a Tuohy-Borst compression fitting. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1204, often near the balloon 1206 and / or the stent 1208. The perforated region 1245 along the capture tube 1224 allows the capture tube to be easily detached from both shafts 1204, 1232 once the catheter is properly installed and is no longer needed.

  Second catheter 1230 includes an elongate shaft 1232 having a radially inflatable balloon 1240 disposed near the distal end of elongate shaft 1232. Stent 1242 is placed over balloon 1240. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 1242 is shorter than the working length of the balloon 1240 so that the proximal portion of the balloon 1240 is not constrained by the stent 1242, and this unconstrained portion of the balloon 1240 will be discussed below. And slidably advanced or retracted under the proximal portion 1222 of the stent 1208 through the side hole 1220. Stent 1242 is crimped to balloon 1240 to prevent release during delivery. At least a portion of the balloon 1240 and the stent 1242 are offset distally relative to the balloon 1206 and the stent 1208 to minimize the device profile. In this embodiment, the distal stent 1242 may be deployed in the main branch of the vessel and the other stent 1208 may be deployed in the side branch of the vessel. Alternatively, the distal stent 1242 may be deployed in the side branch of the blood vessel and the other stent 1208 may be deployed in the main branch of the blood vessel. The second catheter 1230 is a guidewire lumen that extends into a Y-shaped adapter 1246 having a connector 1248 from a distal guidewire port 1238 at the distal end of the elongate shaft 1232 to the proximal end of the elongate shaft 1232. Over-the-wire (OTW) catheter with 1234. The connector 1248 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 1234 exits through connector 1248. Also preferably, the second connector 1244, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 1240 through an inflation lumen (not shown) in the elongate shaft 1232. Enables mounting. A portion of the shaft 1232 is placed in the central channel 1226 of the capture tube 1224, which helps keep the two catheter shafts 1204, 1232 parallel, during delivery and the shaft 1232 is in the central channel 1226. To prevent tangling when it is slidably advanced. A compression fitting 1225 may be used to lock the elongate shafts 1204, 1232 into the capture tube 1224 to prevent axial movement. The compression fixture may be a Tuohy-Borst fixture. Also, another portion of the shaft 1232 is disposed below the proximal portion 1222 of the stent 1208. The second catheter 1230 can also be slidably advanced or retracted under the proximal portion 1222 of the stent 1208 such that the shaft 1232 passes through the side hole 1220 of the stent 1208. Capture tube 1224 may be peeled from shaft 1232 by cutting perforated region 1245. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1232, often near the balloon 1240 or stent 1242.

  13A, 14A, 15A, and 16A illustrate a zipper that allows one catheter to fit into the other. A zipper is essentially a groove that forms a concave receiving cross section and is straight carved into the outer surface of the catheter. The groove can be a single groove on a portion of the catheter or can extend from end to end. Alternatively, the catheter can have a series of short grooves 1-10 centimeters in length that span the length of the catheter or only a portion. The full length end-to-end zipper has a reduced profile and low friction with the blood vessels. The resulting groove can receive another catheter and prevent the catheter from detaching while the operator advances the catheter to the bifurcation. Once at the site, the operator can still move the catheter back and forth slidably relative to each other. A mother catheter that utilizes a groove can have a fully crimped stent, as described in some of the above embodiments, but the operator can use any It is possible to select a commercially available catheter so that the commercially available catheter can be placed via the zipper. A mother catheter with an empty zipper has a mother stent crimped completely over the distal balloon portion. After mounting a commercially available catheter, the operator needs to crimp the proximal portion of the mother stent in situ before starting the clinical procedure. This option may reduce the total inventory of the catheter, but may be extremely valuable to the operator who can have more options for treating bifurcation lesions.

  FIG. 13A illustrates a catheter system 1300 having a distal daughter catheter having an over-the-wire design and a proximal mother catheter having a quick exchange design and a short zipper. FIG. 13B more clearly illustrates the features of the catheter system 1300 of FIG. 13A. Stent delivery system 1300 includes a first catheter 1302 and a second catheter 1330. First catheter 1302 includes an elongate shaft 1304 having a radially expandable balloon 1306 disposed near the distal end of elongate shaft 1304. A stent 1308 having a proximal portion 1322, a distal portion 1314, and a side hole 1320 is disposed over the balloon 1306. Because the distal portion 1314 is crimped to the balloon 1306 to prevent release during delivery, the proximal portion 1322 is partially crimped to the balloon 1306 so that the second catheter 1330 can be Can be slidably advanced under the proximal portion 1322. The first catheter extends from a distal guidewire port 1310 at the distal end of the elongate shaft 1304 to a proximal end of the elongate shaft 1304 and into a Y-shaped adapter 1314 having a connector 1316. An over-the-wire (OTW) catheter. The connector 1316 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 1312 exits through connector 1316. Also preferably, the second connector 1318, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 1306 through an inflation lumen (not shown) in the elongate shaft 1304. Enables mounting. First catheter 1302 also includes a zipper or snap fitting 1324 coupled to elongate shaft 1304. The snap-fit tube 1324 may be coextruded with the first shaft 1304 or may be coupled thereto or otherwise attached using techniques known to those skilled in the art. The snap fit 1324 may alternatively be coupled to the other shaft 1332. Snap fitting 1324 includes a central channel 1326 extending therethrough and is sized to slidably receive a portion of second catheter 1330. The elongated slot 1345 extends along the entire length of the snap fitting 1324 and is sized so that the shaft 1336 may be fitted into the central channel 1326. FIG. 13C illustrates a partial cross-sectional view of FIG. 13B taken along line CC, showing a shaft 1304 having a snap fitting 1324. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1304, often near the balloon 1306 and / or the stent 1308.

  Second catheter 1330 includes an elongate shaft 1332 having a radially expandable balloon 1340 disposed near the distal end of elongate shaft 1332. Stent 1342 is placed over balloon 1340. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 1342 is shorter than the working length of the balloon 1340 so that the proximal portion of the balloon 1340 is not constrained by the stent 1342 and this unconstrained portion of the balloon 1340 will be discussed below. And can be slidably advanced or retracted under the proximal portion 1322 of the stent 1308 through the side hole 1320. Stent 1342 is crimped to balloon 1340 to prevent release during delivery. At least a portion of the balloon 1340 and the stent 1342 are offset distally relative to the balloon 1306 and the stent 1308 to minimize the device profile. In this embodiment, the distal stent 1342 may be deployed in the main branch of the vessel and the other stent 1308 may be deployed in the side branch of the vessel. Alternatively, the distal stent 1342 may be deployed in the side branch of the blood vessel and the other stent 1308 may be deployed in the main branch of the blood vessel. The second catheter 1330 extends from a distal guidewire port 1338 at the distal end of the elongate shaft 1332 to a proximal guidewire port 1336 that is closer to the distal port 1338 than the proximal end of the catheter shaft 1332. A rapid exchange catheter (RX) having a wire lumen 1334. Proximal guidewire port 1336 is also unobstructed by snap fitting 1324 and is preferably more proximal. Preferably, a connector 1344 that is a luer connector is connected to the proximal end of the elongate shaft 1332 and an inflator or other device is used to inflate the balloon 1340 with an inflation lumen (not shown) in the elongate shaft 1332. ). A portion of the shaft 1332 is fitted into the central channel 1326 of the snap fitting 1324 through the slit 1345 and thus the shaft 1332 may slide within the channel 1326. This helps keep the two catheter shafts 1304, 1332 parallel and prevents tangling during delivery and when the shaft 1332 is slidably advanced or retracted relative to the shaft 1304. Also, another portion of shaft 1332 is disposed under proximal portion 1322 of stent 1308. Second catheter 1330 may also be slidably advanced or retracted under proximal portion 1322 of stent 1308 such that shaft 1332 passes through side hole 1320 of stent 1308. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1332, often near the balloon 1340 or stent 1342.

  FIG. 14A illustrates a catheter system 1400 having a proximal mother catheter having a rapid exchange configuration and a distal daughter catheter having an over-the-wire configuration and a short zipper or snap fitting. FIG. 14B more clearly illustrates the features of the catheter system 1400 of FIG. 14A. Stent delivery system 1400 includes a first catheter 1402 and a second catheter 1430. The first catheter 1402 includes an elongate shaft 1404 having a radially expandable balloon 1406 disposed near the distal end of the elongate shaft 1404 and a stent 1408 disposed on the balloon 1406. The stent 1408 may be the same length as the working length of the balloon 1408 or may be shorter. In a preferred embodiment, the stent 1408 is shorter than the working length of the balloon 1406 so that the proximal portion of the balloon 1406 is not constrained by the stent 1408. The proximal portion of the balloon 1406 can be slidably advanced or retracted under the stent 1442 via the side hole 1420. Stent 1408 is crimped to balloon 1406 to prevent release during delivery. The first catheter extends from a distal guidewire port 1410 at the distal end of the elongate shaft 1404 to a proximal end of the elongate shaft 1404 and into a Y-shaped adapter 1414 having a connector 1416. An over-the-wire (OTW) catheter. The connector 1416 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 1412 exits through connector 1416. Also preferably, the second connector 1418, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 1406 through an inflation lumen (not shown) in the elongate shaft 1404. Enables mounting. First catheter 1402 also includes a zipper or snap fitting 1424 coupled to elongate shaft 1404. The snap-fit tube 1424 may be coextruded with the first shaft 1404 or may be coupled thereto or otherwise attached using techniques known to those skilled in the art. The snap fit 1424 may alternatively be coupled to the other shaft 1432. Snap fitting 1424 includes a central channel 1426 extending therethrough and is sized to slidably receive a portion of second catheter 1430. The elongated slot 1445 extends along the entire length of the snap fitting 1424 and is sized so that the shaft 1436 may be fitted into the central channel 1426. FIG. 14C illustrates a partial cross-sectional view of FIG. 14B taken along line CC and shows a shaft 1404 with a snap fitting 1424. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1404, often near the balloon 1406 and / or the stent 1408.

  Second catheter 1430 includes an elongate shaft 1432 having a radially expandable balloon 1440 disposed near the distal end of elongate shaft 1432. A stent 1442 having a proximal portion 1422, a distal portion 1414, and a side hole 1420 is disposed over the balloon 1440. Since the distal portion 1414 is crimped to the balloon 1440 to prevent release during delivery, the proximal portion 1422 is partially crimped to the balloon 1440 so that the elongate shaft 1404 is proximate to the stent 1442. It can be slidably advanced or retracted under the position portion 1422. The stent may preferably have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. At least a portion of the balloon 1406 and the stent 1408 are offset distally with respect to the balloon 1440 and the stent 1442 to minimize the device profile. In this embodiment, the distal stent 1408 may be deployed in the main branch of the vessel and the other stent 1442 may be deployed in the side branch of the vessel. Alternatively, the distal stent 1408 may be deployed in the side branch of the blood vessel and the other stent 1442 may be deployed in the main branch of the blood vessel. The second catheter 1430 extends from a distal guidewire port 1438 at the distal end of the elongate shaft 1432 to a proximal guidewire port 1436 that is closer to the distal port 1438 than to the proximal end of the catheter shaft 1432. A rapid exchange catheter (RX) having a wire lumen 1434. Proximal guidewire port 1436 is also unobstructed by snap fitting 1424 and is preferably more proximal. Preferably, a connector 1444, which is a luer connector, is connected to the proximal end of the elongate shaft 1432 so that an indeflator or other device can be used to inflate the balloon 1440 with an inflation lumen (not shown) in the elongate shaft 1432. ). A portion of the shaft 1432 is fitted into the central channel 1426 of the snap fitting 1424 through the slit 1445 and thus the shaft 1432 may slide within the channel 1426. This helps keep the two catheter shafts 1404, 1432 parallel and prevents entanglement during delivery and when the shaft 1432 is slidably advanced or retracted relative to the shaft 1404. Also, a portion of the shaft 1404 is disposed below the proximal portion 1422 of the stent 1442. The first catheter 1402 can be slidably advanced or retracted under the proximal portion 1422 of the stent 1442 such that the shaft 1404 passes through the side hole 1420 of the stent 1442. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1432, often near the balloon 1440 or stent 1442.

  FIG. 15A illustrates a catheter system 1500 having a double quick-change design with a short zipper or snap fitting. FIG. 15B more clearly illustrates the features of the catheter system 1500 of FIG. 15A. Stent delivery system 1500 includes a first catheter 1502 and a second catheter 1530. First catheter 1502 includes an elongate shaft 1504 having a radially expandable balloon 1506 disposed near the distal end of elongate shaft 1504. A stent 1508 having a proximal portion 1522, a distal portion 1514, and a side hole 1520 is disposed over the balloon 1506. Since distal portion 1514 is crimped to balloon 1506 to prevent release during delivery, proximal portion 1522 is partially crimped to balloon 1506 so that second catheter 1530 is stent 1508. Can be slidably advanced under the proximal portion 1522. The first catheter extends from a distal guidewire port 1510 at the distal end of the elongate shaft 1504 to a proximal guidewire port 1511 that is closer to the distal port 1510 than to the proximal end of the catheter shaft 1504. A rapid exchange catheter (RX) having a lumen 1512. Connector 1516 is coupled to the proximal end of elongate shaft 1504. The connector 1516 is preferably a luer connector, which allows easy coupling with an indeflator or other device for inflation of the balloon 1506. First catheter 1502 also includes a zipper or snap fitting 1524 coupled to elongate shaft 1504. The snap-fit tube 1524 may be coextruded with the first shaft 1504, or may be coupled thereto or otherwise attached using techniques known to those skilled in the art. The snap fit 1524 may alternatively be coupled with the other shaft 1532. Snap fitting 1524 includes a central channel 1526 extending therethrough and is sized to slidably receive a portion of second catheter 1530. The elongated slot 1545 extends along the entire length of the snap fitting 1524 and is sized so that the shaft 1536 may fit into the central channel 1526. FIG. 15C illustrates a partial cross-sectional view of FIG. 15B taken along line CC and shows a shaft 1504 with a snap fitting 1524. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1504, often near the balloon 1506 and / or the stent 1508.

  The second catheter 1530 includes an elongate shaft 1532 having a radially expandable balloon 1540 disposed near the distal end of the elongate shaft 1532. Stent 1542 is placed over balloon 1540. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 1542 is shorter than the working length of the balloon 1540 so that the proximal portion of the balloon 1540 is not constrained by the stent 1542, and this unconstrained portion of the balloon 1540 will be discussed below. And can be slidably advanced or retracted under the proximal portion 1522 of the stent 1508 through the side hole 1520. Stent 1542 is crimped to balloon 1540 to prevent release during delivery. At least a portion of the balloon 1540 and the stent 1542 are offset distally relative to the balloon 1506 and the stent 1508 to minimize the device profile. In this embodiment, the distal stent 1542 may be deployed in the main branch of the blood vessel and the other stent 1508 may be deployed in the side branch of the blood vessel. Alternatively, the distal stent 1542 may be deployed in the side branch of the blood vessel and the other stent 1508 may be deployed in the main branch of the blood vessel. The second catheter 1530 extends from a distal guidewire port 1538 at the distal end of the elongate shaft 1532 to a proximal guidewire port 1536 that is closer to the distal port 1538 than to the proximal end of the catheter shaft 1532. A rapid exchange catheter (RX) having a wire lumen 1534. Proximal guidewire port 1536 is also unobstructed by snap fitting 1524 and may be distal to it. Preferably, a connector 1544, which is a luer connector, is connected to the proximal end of the elongate shaft 1532 so that an indeflator or other device can be used to inflate the balloon 1540 with an inflation lumen (not shown) in the elongate shaft 1532. ). A portion of the shaft 1532 is fitted into the central channel 1526 of the snap fitting 1524 via the slit 1545, and thus the shaft 1532 may slide within the channel 1526. This helps keep the two catheter shafts 1504, 1532 parallel and prevents tangling during delivery and as the shaft 1532 is slidably advanced or retracted relative to the shaft 1504. Also, another portion of shaft 1532 is disposed under proximal portion 1522 of stent 1508. The second catheter 1530 can also be slidably advanced or retracted under the proximal portion 1522 of the stent 1508 such that the shaft 1532 passes through the side hole 1520 of the stent 1508. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1532, often near the balloon 1540 or stent 1542.

  FIG. 16A illustrates a catheter system 1600 having a dual over-the-wire design with short zips or snap fittings. FIG. 16B more clearly illustrates the features of the catheter system 1600 of FIG. 16A. Stent delivery system 1600 includes a first catheter 1602 and a second catheter 1630. First catheter 1602 includes an elongate shaft 1604 having a radially expandable balloon 1606 disposed near the distal end of elongate shaft 1604. A stent 1608 having a proximal portion 1622, a distal portion 1614, and a side hole 1620 is disposed over the balloon 1606. Since the distal portion 1614 is crimped to the balloon 1606 to prevent release during delivery, the proximal portion 1622 is partially crimped to the balloon 1606 so that the second catheter 1630 is stent 1608. Can be slidably advanced under the proximal portion 1622. The first catheter extends from a distal guidewire port 1610 at the distal end of the elongate shaft 1604 to a proximal end of the elongate shaft 1604 into a Y-shaped adapter 1614 having a connector 1616 and a guidewire lumen 1612. An over-the-wire (OTW) catheter. The connector 1616 is preferably a luer connector, which allows for easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 1612 exits through connector 1616. Also preferably, the second connector 1618, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 1606 via an inflation lumen (not shown) in the elongate shaft 1604. Enables mounting. First catheter 1602 also includes a zipper or snap fitting 1624 coupled to elongate shaft 1604. The snap-fit tube 1624 may be coextruded with the first shaft 1604 or may be coupled thereto or otherwise attached using techniques known to those skilled in the art. The snap fit 1624 may alternatively be coupled to the other shaft 1632. Snap fitting 1624 includes a central channel 1626 extending therethrough and is sized to slidably receive a portion of second catheter 1630. The elongated slot 1645 extends along the entire length of the snap fitting 1624 and is sized so that the shaft 1636 may fit into the central channel 1626. FIG. 16C illustrates a partial cross-sectional view of FIG. 16B taken along line CC and shows a shaft 1604 having a snap fitting 1624. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1604, often near the balloon 1606 and / or the stent 1608.

  The second catheter 1630 includes an elongate shaft 1632 having a radially expandable balloon 1640 disposed near the distal end of the elongate shaft 1632. Stent 1642 is placed over balloon 1640. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 1642 is shorter than the working length of the balloon 1640 so that the proximal portion of the balloon 1640 is not constrained by the stent 1642, and this unconstrained portion of the balloon 1640 will be discussed below. And can be slidably advanced or retracted through the side hole 1620 below the proximal portion 1622 of the stent 1608. Stent 1642 is crimped to balloon 1640 to prevent release during delivery. At least a portion of the balloon 1640 and the stent 1642 are offset distally relative to the balloon 1606 and the stent 1608 to minimize the device profile. In this embodiment, the distal stent 1642 may be deployed in the main branch of the vessel and the other stent 1608 may be deployed in the side branch of the vessel. Alternatively, the distal stent 1642 may be deployed in the side branch of the blood vessel and the other stent 1608 may be deployed in the main branch of the blood vessel. A second catheter 1630 is a guidewire lumen that extends into a Y-shaped adapter 1646 having a connector 1648 from a distal guidewire port 1638 at the distal end of the elongate shaft 1632 to the proximal end of the elongate shaft 1632. Over-the-wire (OTW) catheter with 1634. The connector 1648 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 1634 exits through connector 1648. Also preferably, the second connector 1644, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 1640 through an inflation lumen (not shown) in the elongate shaft 1632. Enables mounting. A portion of the shaft 1632 is fitted into the central channel 1626 of the snap fitting 1624 via the slit 1645, and thus the shaft 1632 may slide within the channel 1626. This helps keep the two catheter shafts 1604, 1632 parallel and prevents tangling during delivery and when the shaft 1632 is slidably advanced or retracted relative to the shaft 1604. Also, another portion of the shaft 1632 is disposed under the proximal portion 1622 of the stent 1608. Second catheter 1630 may also be slidably advanced or retracted under proximal portion 1622 of stent 1608 such that shaft 1632 passes through side hole 1620 of stent 1608. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1632, often near the balloon 1640 or stent 1642.

  FIG. 17A illustrates a catheter system 1700 having a distal daughter catheter having a rapid exchange configuration and a proximal mother catheter having an over-the-wire configuration and an end-to-end zipper or snap fitting. This embodiment is similar to that shown in FIGS. 13A-13B, with the main difference being the length of the snap fitting and the location of one of the guidewire ports. FIG. 17B more clearly illustrates the features of the catheter system 1700 of FIG. 17A. Stent delivery system 1700 includes a first catheter 1702 and a second catheter 1730. First catheter 1702 includes an elongate shaft 1704 having a radially expandable balloon 1706 disposed near the distal end of elongate shaft 1704. A stent 1708 having a proximal portion 1722, a distal portion 1714, and a side hole 1720 is disposed over the balloon 1706. Since distal portion 1714 is crimped to balloon 1706 to prevent release during delivery, proximal portion 1722 is partially crimped to balloon 1706 so that second catheter 1730 is stent 1708. Can be slidably advanced under the proximal portion 1722. The first catheter extends from a distal guidewire port 1710 at the distal end of the elongate shaft 1704 to a proximal end of the elongate shaft 1704 into a Y-shaped adapter 1714 having a connector 1716. An over-the-wire (OTW) catheter. The connector 1716 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 1712 exits through connector 1716. Also preferably, the second connector 1718, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 1706 via an inflation lumen (not shown) in the elongate shaft 1704. Enables mounting. The first catheter 1702 also includes a zipper or snap fitting 1724 coupled to the elongate shaft 1704. The snap-fit tube 1724 may be coextruded with the first shaft 1704, or may be coupled thereto or otherwise attached using techniques known to those skilled in the art. The snap fit 1724 may alternatively be coupled with the other shaft 1732. Snap fitting 1724 includes a central channel 1726 extending therethrough and is sized to slidably receive a portion of second catheter 1730. The elongated slot 1745 extends along the entire length of the snap fitting 1724 and is sized so that the shaft 1736 may fit into the central channel 1726. The snap fitting 1724 may extend from the distal end of the connectors 1714, 1744 to the proximal end of the balloon 1706, or only partially extend between the connectors 1714, 1744 and the balloon 1706, It may be shorter. FIG. 17C illustrates a partial cross-sectional view of FIG. 17B taken along line CC, showing a shaft 1704 with a snap fitting 1724. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1704, often near the balloon 1706 and / or the stent 1708.

  The second catheter 1730 includes an elongate shaft 1732 having a radially expandable balloon 1740 disposed near the distal end of the elongate shaft 1732. Stent 1742 is placed over balloon 1740. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 1742 is shorter than the working length of the balloon 1740 so that the proximal portion of the balloon 1740 is not constrained by the stent 1742, and this unconstrained portion of the balloon 1740 will be discussed below. And can be slidably advanced or retracted under the proximal portion 1722 of the stent 1708 through the side hole 1720. Stent 1742 is crimped to balloon 1740 to prevent release during delivery. At least a portion of balloon 1740 and stent 1742 are offset distally with respect to balloon 1706 and stent 1708 to minimize the device profile. In this embodiment, the distal stent 1742 may be deployed in the main branch of the blood vessel and the other stent 1708 may be deployed in the side branch of the blood vessel. Alternatively, the distal stent 1742 may be deployed in the side branch of the blood vessel and the other stent 1708 may be deployed in the main branch of the blood vessel. Second catheter 1730 extends from a distal guidewire port 1738 at the distal end of elongate shaft 1732 to a proximal guidewire port 1736 that is closer to distal port 1738 than the proximal end of catheter shaft 1732. A rapid exchange catheter (RX) having a wire lumen 1734. Proximal guidewire port 1736 is also unobstructed by snap fitting 1724 and is preferably distal to it. Preferably, a connector 1744, which is a luer connector, is connected to the proximal end of the elongate shaft 1732 and an indeflator or other device is used to inflate the balloon 1740 with an inflation lumen (not shown) in the elongate shaft 1732. ). A portion of the shaft 1732 is fitted into the central channel 1726 of the snap fitting 1724 through the slit 1745 and thus the shaft 1732 may slide within the channel 1726. This helps keep the two catheter shafts 1704, 1732 parallel and prevents entanglement during delivery and when the shaft 1732 is slidably advanced or retracted relative to the shaft 1704. Also, another portion of shaft 1732 is disposed under proximal portion 1722 of stent 1708. The second catheter 1730 can also be slidably advanced or retracted under the proximal portion 1722 of the stent 1708 such that the shaft 1732 passes through the side hole 1720 of the stent 1708. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1732, often near the balloon 1740 or stent 1742.

  FIG. 18A illustrates a catheter system 1800 having a proximal mother catheter having a rapid exchange configuration and a distal daughter catheter having an end-to-end zipper or snap fitting. FIG. 18A is similar to that shown in FIGS. 14A-14B, the main difference being the length of the snap fitting and the location of one of the guidewire ports. FIG. 18B more clearly illustrates the features of the catheter system 1800 of FIG. 18A. Stent delivery system 1800 includes a first catheter 1802 and a second catheter 1830. The first catheter 1802 includes an elongate shaft 1804 having a radially expandable balloon 1806 disposed near the distal end of the elongate shaft 1804 and a stent 1808 disposed on the balloon 1806. The stent 1808 may be the same length as the working length of the balloon 1808 or may be shorter. In a preferred embodiment, the stent 1808 is shorter than the working length of the balloon 1806 so that the proximal portion of the balloon 1806 remains unconstrained by the stent 1808. The proximal portion of the balloon 1806 can be slidably advanced or retracted under the stent 1842 via the side hole 1820. Stent 1808 is crimped to balloon 1806 to prevent release during delivery. The first catheter extends from a distal guidewire port 1810 at the distal end of the elongate shaft 1804 to a proximal end of the elongate shaft 1804 into a Y-shaped adapter 1814 having a connector 1816. An over-the-wire (OTW) catheter. The connector 1816 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 1812 exits through connector 1816. Also preferably, the second connector 1818, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 1806 through an inflation lumen (not shown) in the elongate shaft 1804. Enables mounting. First catheter 1802 also includes a zipper or snap fitting 1824 coupled to elongate shaft 1804. The snap-fit tube 1824 may be coextruded with the first shaft 1804 or may be coupled thereto or otherwise attached using techniques known to those skilled in the art. The snap fit 1824 may alternatively be coupled to the other shaft 1832. Snap fitting 1824 includes a central channel 1826 extending therethrough and is sized to slidably receive a portion of second catheter 1830. The elongated slot 1845 extends along the entire length of the snap fitting 1824 and is sized so that the shaft 1836 may be fitted into the central channel 1826. FIG. 18C illustrates a partial cross-sectional view of FIG. 18B taken along line CC and shows a shaft 1804 having a snap fitting 1824. The snap fitting 1824 may extend from the distal end of the connectors 1814, 1844 to the proximal end of the balloon 1840, or extend only partially between the connector 1814, 1844 and the balloon 1806, It may be shorter. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1804, often near the balloon 1806 and / or the stent 1808.

  Second catheter 1830 includes an elongate shaft 1832 having a radially expandable balloon 1840 disposed near the distal end of elongate shaft 1832. A stent 1842 having a proximal portion 1822, a distal portion 1814, and a side hole 1820 is disposed over the balloon 1840. Since the distal portion 1814 is crimped to the balloon 1840 to prevent release during delivery, the proximal portion 1822 is partially crimped to the balloon 1840 so that the elongate shaft 1804 is proximate to the stent 1842. It can be slidably advanced or retracted under the position portion 1822. The stent may preferably have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. At least a portion of the balloon 1806 and the stent 1808 are offset distally relative to the balloon 1840 and the stent 1842 to minimize the device profile. In this embodiment, the distal stent 1808 may be deployed in the main branch of the vessel and the other stent 1842 may be deployed in the side branch of the vessel. Alternatively, the distal stent 1808 may be deployed in the side branch of the blood vessel and the other stent 1842 may be deployed in the main branch of the blood vessel. The second catheter 1830 extends from a distal guidewire port 1838 at the distal end of the elongate shaft 1832 to a proximal guidewire port 1836 that is closer to the distal port 1838 than to the proximal end of the catheter shaft 1832. A rapid exchange catheter (RX) having a wire lumen 1834. Proximal guidewire port 1836 is also unobstructed by snap fitting 1824 and is preferably distal to it. A connector 1844, preferably a luer connector, is connected to the proximal end of the elongate shaft 1832 so that an indeflator or other device can be used to inflate the balloon 1840 with an inflation lumen (not shown) ). A portion of the shaft 1832 is fitted through the slit 1845 into the central channel 1826 of the snap fitting 1824 so that the shaft 1832 may slide within the channel 1826. This helps keep the two catheter shafts 1804, 1832 parallel and prevents tangling during delivery and when the shaft 1832 is slidably advanced or retracted relative to the shaft 1804. Also, a portion of the shaft 1804 is disposed under the proximal portion 1822 of the stent 1842. The first catheter 1802 can be slidably advanced or retracted under the proximal portion 1822 of the stent 1842 such that the shaft 1804 passes through the side hole 1820 of the stent 1842. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1832, often near the balloon 1840 or stent 1842.

  FIG. 19A illustrates a catheter system 1900 having a double quick-change design with an end-to-end zipper or snap fitting. FIG. 19A is similar to that shown in FIGS. 15A-15B, the main difference being the length of the snap fitting. FIG. 19B more clearly illustrates the features of the catheter system 1900 of FIG. 19A. Stent delivery system 1900 includes a first catheter 1902 and a second catheter 1930. The first catheter 1902 includes an elongate shaft 1904 having a radially expandable balloon 1906 disposed near the distal end of the elongate shaft 1904. A stent 1908 having a proximal portion 1922, a distal portion 1914, and a side hole 1920 is disposed over the balloon 1906. Because the distal portion 1914 is crimped to the balloon 1906 to prevent release during delivery, the proximal portion 1922 is partially crimped to the balloon 1906 so that the second catheter 1930 is a stent 1908. Can be slidably advanced under the proximal portion 1922. The first catheter extends from a distal guidewire port 1910 at the distal end of the elongate shaft 1904 to a proximal guidewire port 1911 closer to the distal port 1910 than the proximal end of the catheter shaft 1904. A rapid exchange catheter (RX) having a lumen 1912. Connector 1916 is coupled to the proximal end of elongate shaft 1904. The connector 1916 is preferably a luer connector, which allows easy connection with an indeflator or other device for inflation of the balloon 1906. The first catheter 1902 also includes a zipper or snap fitting 1924 coupled to the elongate shaft 1904. The snap-fit tube 1924 may be coextruded with the first shaft 1904, or may be coupled thereto or otherwise attached using techniques known to those skilled in the art. The snap fit 1924 may alternatively be coupled to the other shaft 1932. The snap fitting 1924 includes a central channel 1926 extending therethrough and is sized to slidably receive a portion of the second catheter 1930. The elongated slot 1945 extends along the entire length of the snap fitting 1924 and is sized so that the shaft 1932 may fit into the central channel 1926. FIG. 19C illustrates a partial cross-sectional view of FIG. 19B taken along line CC, showing a shaft 1904 having a snap fitting 1924. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1904, often near the balloon 1906 and / or the stent 1908.

  Second catheter 1930 includes an elongate shaft 1932 having a radially expandable balloon 1940 disposed near the distal end of elongate shaft 1932. Stent 1942 is placed over balloon 1940. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 1942 is shorter than the working length of the balloon 1940 so that the proximal portion of the balloon 1940 is not constrained by the stent 1942, and this unconstrained portion of the balloon 1940 will be discussed below. And can be slidably advanced or retracted under the proximal portion 1922 of the stent 1908 through the side holes 1920. Stent 1942 is crimped to balloon 1940 to prevent release during delivery. At least a portion of the balloon 1940 and the stent 1942 are offset distally relative to the balloon 1906 and the stent 1908 to minimize the device profile. In this embodiment, the distal stent 1942 may be deployed in the main branch of the vessel and the other stent 1908 may be deployed in the side branch of the vessel. Alternatively, the distal stent 1942 may be deployed in the side branch of the blood vessel and the other stent 1908 may be deployed in the main branch of the blood vessel. Second catheter 1930 extends from a distal guidewire port 1938 at the distal end of elongate shaft 1932 to a proximal guidewire port 1936 that is closer to distal port 1938 than the proximal end of catheter shaft 1932. A rapid exchange catheter (RX) having a wire lumen 1934. Proximal guidewire port 1936 is also unobstructed by snap fitting 1924 and may be distal to it. A connector 1944, which is preferably a luer connector, is connected to the proximal end of the elongate shaft 1932 and an inflator or other device is connected to an inflation lumen (not shown) in the elongate shaft 1932 for inflation of the balloon 1940. ). A portion of the shaft 1932 is fitted into the central channel 1926 of the snap fitting 1924 through the slit 1945 and thus the shaft 1932 may slide within the channel 1926. This helps keep the two catheter shafts 1904, 1932 parallel and prevents entanglement during delivery and when the shaft 1932 is slidably advanced or retracted relative to the shaft 1904. Also, another portion of shaft 1932 is disposed under proximal portion 1922 of stent 1908. The second catheter 1930 can also be slidably advanced or retracted under the proximal portion 1922 of the stent 1908 such that the shaft 1932 passes through the side hole 1920 of the stent 1908. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 1932, often near the balloon 1940 or stent 1942.

  FIG. 20A illustrates a catheter system 2000 having a dual over-the-wire design with an end-to-end zipper or snap fitting. FIG. 20A is similar to that shown in FIGS. 16A-16B, the main difference being the length of the snap fitting. FIG. 20B more clearly illustrates the features of the catheter system 2000 of FIG. 20A. Stent delivery system 2000 includes a first catheter 2002 and a second catheter 2030. The first catheter 2002 includes an elongate shaft 2004 having a radially expandable balloon 2006 disposed near the distal end of the elongate shaft 2004. A stent 2008 having a proximal portion 2022, a distal portion 2014, and a side hole 2020 is disposed on the balloon 2006. Since the distal portion 2014 is crimped to the balloon 2006 to prevent release during delivery, the proximal portion 2022 is partially crimped to the balloon 2006 so that the second catheter 2030 can be Can be slidably advanced under the proximal portion 2022. A first catheter extends from a distal guidewire port 2010 at the distal end of the elongate shaft 2004 to a proximal end of the elongate shaft 2004 into a Y-shaped adapter 2014 having a connector 2016. An over-the-wire (OTW) catheter. The connector 2016 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 2012 exits through connector 2016. Also preferably, the second connector 2018, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 2006 through an inflation lumen (not shown) in the elongate shaft 2004. Enables mounting. The first catheter 2002 also includes a zipper or snap fitting 2024 coupled to the elongate shaft 2004. The snap-fit tube 2024 may be coextruded with the first shaft 2004 or may be coupled thereto or otherwise attached using techniques known to those skilled in the art. The snap fit 2024 may alternatively be coupled with the other shaft 2032. The snap fitting 2024 includes a central channel 2026 extending therethrough and is sized to slidably receive a portion of the second catheter 2030. The elongated slot 2045 extends along the entire length of the snap fitting 2024 and is sized so that the shaft 2036 may fit into the central channel 2026. FIG. 20C illustrates a partial cross-sectional view of FIG. 20B taken along line CC and shows a shaft 2004 having a snap fitting 2024. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 2004, often near the balloon 2006 and / or the stent 2008.

  The second catheter 2030 includes an elongate shaft 2032 having a radially expandable balloon 2040 disposed near the distal end of the elongate shaft 2032. Stent 2042 is placed over balloon 2040. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 2042 is shorter than the working length of the balloon 2040 so that the proximal portion of the balloon 2040 is not constrained by the stent 2042, and this unconstrained portion of the balloon 2040 will be discussed below. And can be slidably advanced or retracted through the side hole 2020 under the proximal portion 2022 of the stent 2008. Stent 2042 is crimped to balloon 2040 to prevent release during delivery. At least a portion of the balloon 2040 and the stent 2042 are offset distally relative to the balloon 2006 and the stent 2008 to minimize the device profile. In this embodiment, the distal stent 2042 may be deployed in the main branch of the vessel and the other stent 2008 may be deployed in the side branch of the vessel. Alternatively, the distal stent 2042 may be deployed in the side branch of the blood vessel and the other stent 2008 may be deployed in the main branch of the blood vessel. A second catheter 2030 is a guidewire lumen that extends into a Y-shaped adapter 2046 having a connector 2048 from a distal guidewire port 2038 at the distal end of the elongate shaft 2032 to the proximal end of the elongate shaft 2032. An over-the-wire (OTW) catheter with 2034. The connector 2048 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 2034 exits through connector 2048. Also preferably, the second connector 2044, which is a luer connector, provides an indeflator or other device to the catheter for inflation of the balloon 2040 through an inflation lumen (not shown) in the elongate shaft 2032. Enables mounting. A portion of the shaft 2032 is fitted into the central channel 2026 of the snap fitting 2024 through the slit 2045 and thus the shaft 2032 may slide within the channel 2026. This helps keep the two catheter shafts 2004, 2032 parallel and prevents entanglement during delivery and as the shaft 2032 is slidably advanced or retracted relative to the shaft 2004. Also, another portion of the shaft 2032 is disposed under the proximal portion 2022 of the stent 2008. The second catheter 2030 can also be slidably advanced or retracted under the proximal portion 2022 of the stent 2008 such that the shaft 2032 passes through the side hole 2020 of the stent 2008. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 2032, often near the balloon 2040 or stent 2042.

  21A, 22A, 23A, and 24A illustrate a catheter that can be used with alternative embodiments, where the mother catheter provides the operator with a mother stent crimped onto the distal portion of the mother catheter balloon. . The proximal portion of the mother stent is either not crimped or partially crimped. An operator can place any commercially available catheter or balloon onto the wire through the proximal end of the mother stent and withdraw from the side hole of the mother stent. The operator can align the catheter to fit the patient's anatomy and crimp the proximal portion of the mother stent. The operator can crimp the stent firmly so that the catheters do not move relative to each other. The operator can place the catheter in the bifurcation, pull back the commercial catheter if necessary, and adjust the alignment if necessary. The operator can then gradually push the system distally to ensure complete juxtaposition.

  FIG. 21A illustrates a catheter system 2100 having a distal daughter catheter having a rapid exchange configuration and a proximal mother catheter having an over-the-wire configuration. FIG. 21B more clearly illustrates the features of the catheter system 2100 of FIG. 21A. Stent delivery system 2100 includes a first catheter 2102 and a second catheter 2130. First catheter 2102 includes an elongate shaft 2104 having a radially expandable balloon 2106 disposed near the distal end of elongate shaft 2104. A stent 2108 having a proximal portion 2122, a distal portion 2114, and a side hole 2120 is disposed over the balloon 2106. Since the distal portion 2114 is crimped to the balloon 2106 to prevent release during delivery, the proximal portion 2122 is partially crimped to the balloon 2106 so that the second catheter 2130 can be Can be slidably advanced under the proximal portion 2122. The first catheter extends from a distal guidewire port 2110 at the distal end of the elongate shaft 2104 to a proximal end of the elongate shaft 2104 into a Y-shaped adapter 2114 having a connector 2116. An over-the-wire (OTW) catheter. The connector 2116 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 2112 exits through connector 2116. Also preferably, the second connector 2118, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 2106 through an inflation lumen (not shown) in the elongate shaft 2104. Enables mounting. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along shaft 2104, often near balloon 2106 and / or stent 2108.

  The second catheter 2130 includes an elongate shaft 2132 having a radially expandable balloon 2140 disposed near the distal end of the elongate shaft 2132. Stent 2142 is placed over balloon 2140. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 2142 is shorter than the working length of the balloon 2140 so that the proximal portion of the balloon 2140 is not constrained by the stent 2142, and this unconstrained portion of the balloon 2140 will be discussed below. And can be slidably advanced or retracted through the side hole 2120 under the proximal portion 2122 of the stent 2108. Stent 2142 is crimped to balloon 2140 to prevent release during delivery. At least a portion of the balloon 2140 and the stent 2142 are offset distally relative to the balloon 2106 and the stent 2108 to minimize the device profile. In this embodiment, the distal stent 2142 may be deployed in the main branch of the vessel and the other stent 2108 may be deployed in the side branch of the vessel. Alternatively, the distal stent 2142 may be deployed in the side branch of the blood vessel and the other stent 2108 may be deployed in the main branch of the blood vessel. The second catheter 2130 extends from a distal guidewire port 2138 at the distal end of the elongate shaft 2132 to a proximal guidewire port 2136 that is closer to the distal port 2138 than to the proximal end of the catheter shaft 2132. A rapid exchange catheter (RX) having a wire lumen 2134. A connector 2144, preferably a luer connector, is connected to the proximal end of the elongate shaft 2132 so that an indeflator or other device can be used to inflate the balloon 2140 with an inflation lumen (not shown) ). Having a portion of the shaft 2132 disposed under the proximal portion 2122 of the stent 2108 helps keep the catheter shafts 2104, 2132 parallel and allows the shaft 2132 to slide relative to the shaft 2104 during delivery. To prevent entanglement when moving forward or backward. Also, another portion of the shaft 2132 is disposed under the proximal portion 2122 of the stent 2108. Second catheter 2130 may also be slidably advanced or retracted under proximal portion 2122 of stent 2108 such that shaft 2132 passes through side hole 2120 of stent 2108. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 2132, often near the balloon 2140 or the stainless 2142.

  FIG. 22A illustrates a catheter system 2200 having a proximal mother catheter having an over-the-wire design and a distal daughter catheter having an over-the-wire configuration. FIG. 22B more clearly illustrates the features of the catheter system 2200 of FIG. 22A. Stent delivery system 2200 includes a first catheter 2202 and a second catheter 2230. The first catheter 2202 includes an elongate shaft 2204 having a radially expandable balloon 2206 disposed near the distal end of the elongate shaft 2204 and a stent 2208 disposed on the balloon 2206. The stent 2208 may be the same length as the working length of the balloon 2208 or may be shorter. In a preferred embodiment, the stent 2208 is shorter than the working length of the balloon 2206 so that the proximal portion of the balloon 2206 remains unconstrained by the stent 2208. The proximal portion of the balloon 2206 may be slidably advanced and retracted under the stent 2242 via the side hole 2220. Stent 2208 is crimped to balloon 2206 to prevent release during delivery. The first catheter extends from a distal guidewire port 2210 at the distal end of the elongate shaft 2204 to a proximal end of the elongate shaft 2204 into a Y-shaped adapter 2214 having a connector 2216. An over-the-wire (OTW) catheter. The connector 2216 is preferably a luer connector, which allows easy connection with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 2212 exits through connector 2216. Also preferably, the second connector 2218, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 2206 via an inflation lumen (not shown) in the elongate shaft 2204. Enables mounting. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 2204, often near the balloon 2206 and / or the stent 2208.

  Second catheter 2230 includes an elongate shaft 2232 having a radially expandable balloon 2240 disposed near the distal end of elongate shaft 2232. A stent 2242 having a proximal portion 2222, a distal portion 2214, and side holes 2220 is disposed over the balloon 2240. Since the distal portion 2214 is crimped to the balloon 2240 to prevent release during delivery, the proximal portion 2222 is partially crimped to the balloon 2240 so that the elongate shaft 2204 is proximate to the stent 2242. It can be slidably advanced or retracted under the position portion 2222. The stent may preferably have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. At least a portion of the balloon 2206 and the stent 2208 are offset distally relative to the balloon 2240 and the stent 2242 to minimize the device profile. In this embodiment, the distal stent 2208 may be deployed in the main branch of the vessel and the other stent 2242 may be deployed in the side branch of the vessel. Alternatively, the distal stent 2208 may be deployed in the side branch of the blood vessel and the other stent 2242 may be deployed in the main branch of the blood vessel. The second catheter 2230 extends from a distal guidewire port 2238 at the distal end of the elongate shaft 2232 to a proximal guidewire port 2236 that is closer to the distal port 2238 than to the proximal end of the catheter shaft 2232. A rapid exchange catheter (RX) having a wire lumen 2234. Preferably, a connector 2244 that is a luer connector is connected to the proximal end of the elongate shaft 2232 so that an indeflator or other device can be inflated in the elongate shaft 2232 (not shown) for inflation of the balloon 2240. ). Having a portion of the shaft 2204 disposed under the proximal portion 2222 of the stent 2208 helps keep the catheter shafts 2202, 2232 parallel and allows the shaft 2204 to slide relative to the shaft 2232 during delivery. To prevent entanglement when moving forward or backward. The first catheter 2202 can be slidably advanced or retracted under the proximal portion 2222 of the stent 2242 such that the shaft 2204 passes through the side hole 2220 of the stent 2242. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 2232, often near the balloon 2240 or the stainless 2242.

  FIG. 23A illustrates a catheter system 2300 having a double rapid exchange design. FIG. 23B more clearly illustrates the features of the catheter system 2300 of FIG. 23A. Stent delivery system 2300 includes a first catheter 2302 and a second catheter 2330. First catheter 2302 includes an elongate shaft 2304 having a radially expandable balloon 2306 disposed near the distal end of elongate shaft 2304. A stent 2308 having a proximal portion 2322, a distal portion 2314, and a side hole 2320 is disposed over the balloon 2306. Since the distal portion 2314 is crimped to the balloon 2306 to prevent release during delivery, the proximal portion 2322 is partially crimped to the balloon 2306 so that the second catheter 2330 is stent 2308. Can be slidably advanced under the proximal portion 2322. The first catheter extends from a distal guidewire port 2310 at the distal end of the elongate shaft 2304 to a proximal guidewire port 2311 that is closer to the distal port 2310 than to the proximal end of the catheter shaft 2304. A rapid exchange catheter (RX) having a lumen 2312. Connector 2316 is coupled to the proximal end of elongate shaft 2304. The connector 2116 is preferably a luer connector, which allows easy connection with an indeflator or other device for inflation of the balloon 2306. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 2304, often near the balloon 2306 and / or the stent 2308.

  Second catheter 2330 includes an elongate shaft 2332 having a radially expandable balloon 2340 disposed near the distal end of elongate shaft 2332. Stent 2342 is placed over balloon 2340. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 2342 is shorter than the working length of the balloon 2340 so that the proximal portion of the balloon 2340 is not constrained by the stent 2342, and this unconstrained portion of the balloon 2340 will be discussed below. And can be slidably advanced or retracted under the proximal portion 2322 of the stent 2308 through the side hole 2320. Stent 2342 is crimped to balloon 2340 to prevent release during delivery. At least a portion of balloon 2340 and stent 2342 are offset distally with respect to balloon 2306 and stent 2308 to minimize the device profile. In this embodiment, the distal stent 2342 may be deployed in the main branch of the vessel and the other stent 2308 may be deployed in the side branch of the vessel. Alternatively, the distal stent 2342 may be deployed in the side branch of the blood vessel and the other stent 2308 may be deployed in the main branch of the blood vessel. The second catheter 2330 extends from a distal guidewire port 2338 at the distal end of the elongate shaft 2332 to a proximal guidewire port 2336 that is closer to the distal port 2338 than to the proximal end of the catheter shaft 2332. A rapid exchange catheter (RX) having a wire lumen 2334. A connector 2344, preferably a luer connector, is connected to the proximal end of the elongate shaft 2332 so that an indeflator or other device can be used to inflate the balloon 2340 with an inflation lumen (not shown) ). Having a portion of the shaft 2332 disposed under the proximal portion 2322 of the stent 2208 helps keep the catheters 2302, 2332 parallel and allows the shaft 2332 to slide relative to the shaft 2304 during delivery. Prevent tangling when moving forward or backward. The second catheter 2330 can also be slidably advanced or retracted under the proximal portion 2322 of the stent 2308 such that the shaft 2332 passes through the side hole 2320 of the stent 2308. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 2332, often near the balloon 2340 or the stainless 2342.

  FIG. 24A illustrates a catheter system 2400 having a dual over-the-wire design. FIG. 24B more clearly illustrates the features of the catheter system 2400 of FIG. 24A. Stent delivery system 2400 includes a first catheter 2402 and a second catheter 2430. The first catheter 2402 includes an elongate shaft 2404 having a radially expandable balloon 2406 disposed near the distal end of the elongate shaft 2404. A stent 2408 having a proximal portion 2422, a distal portion 2414, and a side hole 2420 is disposed over the balloon 2406. Since distal portion 2414 is crimped to balloon 2406 to prevent release during delivery, proximal portion 2422 is partially crimped to balloon 2406 so that second catheter 2430 is stent 2408. Can be slidably advanced under the proximal portion 2422. The first catheter extends from a distal guidewire port 2410 at the distal end of the elongate shaft 2404 to a proximal end of the elongate shaft 2404 into a Y-shaped adapter 2414 having a connector 2416. An over-the-wire (OTW) catheter. The connector 2416 is preferably a luer connector, which allows for easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 2412 exits through connector 2416. Also preferably, the second connector 2418, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 2406 via an inflation lumen (not shown) in the elongate shaft 2404. Enables mounting. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 2404, often near the balloon 2406 and / or the stent 2408.

  Second catheter 2430 includes an elongate shaft 2432 having a radially expandable balloon 2440 disposed near the distal end of elongate shaft 2432. Stent 2442 is placed over balloon 2440. The stent may have a length that matches the working length of the balloon, or the stent length may be shorter than the working length of the balloon. In a preferred embodiment, the stent 2442 is shorter than the working length of the balloon 2440 so that the proximal portion of the balloon 2440 is not constrained by the stent 2442, and this unconstrained portion of the balloon 2440 will be discussed below. And can be slidably advanced or retracted under the proximal portion 2422 of the stent 2408 through the side hole 2420. Stent 2442 is crimped to balloon 2440 to prevent release during delivery. At least a portion of the balloon 2440 and the stent 2442 are offset distally with respect to the balloon 2406 and the stent 2408 to minimize the device profile. In this embodiment, the distal stent 2442 may be deployed in the main branch of the vessel and the other stent 2408 may be deployed in the side branch of the vessel. Alternatively, the distal stent 2442 may be deployed in the side branch of the blood vessel and the other stent 2408 may be deployed in the main branch of the blood vessel. The second catheter 2430 extends from a distal guidewire port 2438 at the distal end of the elongate shaft 2432 to a proximal end of the elongate shaft 2432 into a Y-shaped adapter 2446 having a connector 2448. Over-the-wire (OTW) catheter with 2434. Connector 2448 is preferably a luer connector, which allows easy coupling with a syringe or other device for flowing or injecting contrast agent into the lumen. When not connected, guidewire lumen 2434 exits through connector 2448. Also preferably, the second connector 2444, which is a luer connector, is an indeflator or other device to the catheter for inflation of the balloon 2440 through an inflation lumen (not shown) in the elongate shaft 2432. Enables mounting. Having a portion of the shaft 2432 disposed under the proximal portion 2422 of the stent 2408 helps keep the catheter shafts 2402, 2430 parallel and allows the shaft 2432 to slide relative to the shaft 2404 during delivery. To prevent entanglement when moving forward or backward. The second catheter 2430 can also be slidably advanced or retracted under the proximal portion 2422 of the stent 2408 such that the shaft 2432 passes through the side hole 2420 of the stent 2408. To help mark the proximal and distal ends of the stent or balloon, and as discussed elsewhere herein, to facilitate alignment of the two catheters during stent deployment, X Radiopaque markers may be placed at various locations along the shaft 2432, often near the balloon 2440 or stainless 2442.

  In any of the embodiments disclosed herein, commercially available catheters and commercially available stents may be tuned to form the illustrated system. In still other embodiments, commercially available catheters that are single use devices for treating a single blood vessel may be mated together in various combinations and connected together using a polymer sleeve. The operator selects two catheters for the patient's anatomy and then slides a sized polymer sleeve over both catheters from the distal end. Once the operator has aligned the catheters, the polymer sleeve can be treated with heat or a light source to cause the two catheters to contract and frictionally couple. The polymer sleeve is made of a typical polymer that can act as a shrink wrap when treated with heat or a light source. The polymer of the polymer sleeve can be made of, for example, polyolefin, a chemical used in making shrink wrap. The polymer sleeve does not crosslink or covalently bond to the catheter, several polymers are commercially available, have the required properties, thinness, strength, non-adhesiveness, and reaction time of 10 minutes or less for their source. Polymer sleeves are typically 15 centimeters long and have various diameters to fit typical catheter diameters from 4 French to 20 French. The operator can test that the bond persists by applying a slight pressure before the procedure. If the polymer sleeve does not persist firmly, the operator may choose to use a smaller diameter polymer sleeve or use multiple polymer sleeves by placing the polymer sleeves adjacent to each other. Also good. Alternatively, several smaller sleeves 1-10 centimeters in length can be placed over several different parts of the catheter.

  In any of the embodiments discussed herein, the therapeutic agent may be placed on a stent or balloon and eluted therefrom in a controlled manner into a target treatment area, such as a stenotic lesion. Exemplary therapeutic agents help prevent restenosis, hyperplasia, or have other therapeutic utilities. Exemplary anti-hyperplasias include anti-cancer drugs such as paclitaxel, methotrexate, and batimastat, doxycycline, tetracycline, rapamycin, everolimus, biolimus A9, novolimus, myolimus, zotarolimus, and other classes and derivatives of rapamycin and actinomycin Antibiotics such as, dexamethasone and amino inhibitors such as methylprednisolone, nitric oxide sources such as nitroprusside, estrogens, estradiol, and the like. Methods for applying therapeutic agents to stents or balloons are well known to those skilled in the art and are described in the patent and scientific literature.

(Stent delivery)
Figures 25A-30B illustrate an exemplary delivery sequence of the preferred embodiment in eight steps. Step 1 illustrates the introduction of a 0.035 inch guidewire up to a branch. Step 2 illustrates the tracking of the guide catheter over the guide wire. Step 3 illustrates guide wire removal and guide catheter placement locations. Step 4 illustrates the tracking and placement of the rapid exchange compatible wire in the daughter vessel and the over-the-wire compatible wire in the mother vessel. Steps 5A and 5B illustrate the distal tracking of the catheter system on both guidewires. Step 6A illustrates daughter balloon inflation and daughter stent placement, as well as partial deployment of the mother stent. Step 6B illustrates the inflation of the mother balloon to place the distal portion of the mother stent within the mother vessel. Step 7A illustrates the mother stent in the main branch with a side hole facing the daughter vessel. Step 7B illustrates a bifurcated stent that is partially within the daughter vessel and the daughter port that is fully open and continues to the mother vessel.

  In an alternative embodiment, the delivery catheter mother balloon has a tapered end to accommodate balloons and stents having a non-uniform profile. For example, the proximal end of the daughter vessel stent may be designed to have a larger circumference than the distal end to compensate for the natural bifurcation anatomy. The daughter vessel balloon also has a taper to properly expand the stent and ensure full apposition. In addition, it is possible to design a mother stent to specifically expand along its shape and compensate for larger arterial diameters in the ridges or openings. In other words, the proximal and distal ends of the mother vessel balloon and the mother vessel stent are smaller in circumference, but the central portion of the mother vessel stent has a larger circumference. In an alternative embodiment, the mother vessel balloon has a tapered end to accommodate the distal balloon catheter portion and the guidewire lumen. Furthermore, the mother vessel balloon may be designed for differential dilation to accommodate natural vasculature.

  In a preferred embodiment, the distal (daughter) balloon catheter portion is crimped with a half stent on a rapid exchange catheter. The daughter vessel stent is about 4-20 millimeters in length and the daughter vessel balloon is about twice as long. The mother vessel stent is approximately 10-30 millimeters in length and is specifically crimped to allow independent operation of the daughter balloon catheter portion. The distal portion of the mother vessel stent is crimped firmly enough to prevent the entire stent from being unintentionally detached during the procedure. The proximal portion of the mother vessel stent is crimped firmly enough to reduce the cross profile and to allow the daughter balloon catheter portion to be moved distally or proximally relative to the mother balloon catheter portion. . The proximal (mother) balloon catheter portion is preferably an over-the-wire design with a mother vessel balloon approximately 3 cm proximal to the daughter vessel balloon. In an alternative embodiment, the stent is designed to allow differential expansion of the intermediate portion of the stent relative to the proximal and distal ends. In particular, this design facilitates placement of the stent across the bifurcated lesion in the mother vessel because the circumference of the intermediate portion is greater with respect to the end than a stent having a constant profile. Further, the contour can be adjusted so that the maximum circumference can be located proximal or distal to the midpoint of the stent. In certain embodiments, the maximum circumference is distal to the midpoint of the stent, but can be easily reversed for changing patient anatomy. The partial crimp has the following main features that allow it to maintain sufficient stent retention during delivery and deployment and still allow secondary system tunability and deliverability.

  FIG. 31 shows a partially crimped bifurcated stent prior to deployment on any balloon catheter. Figures 32-34 illustrate an embodiment of the present invention in three steps. First, the bifurcated stent is partially crimped onto the mother catheter balloon over approximately one third of its distal portion, the daughter catheter is loaded through the mother catheter and the mother stent, and the daughter stent is separate. Can be crimped. Second, the daughter stent is crimped and pulled back proximally to align the proximal end of the daughter stent near the distal end of the mother stent. Third and finally, the proximal portion of the mother stent can be crimped to reduce the outer diameter, but still allow independent movement of the two catheters relative to each other.

(Stent crimp)
The following description describes an approach for crimping a mother stent. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the described crimp approach. However, the present invention can be practiced without specific details. Moreover, well-known features may be omitted or simplified in order not to obscure the described crimp approach.

  Referring now to the drawings, FIG. 35A shows an example embodiment delivery catheter 3510. Delivery catheter 3510 includes an elongate shaft 3512 and an expandable member 3514 (eg, an expandable balloon) disposed at the end of the elongate shaft 3512.

  FIG. 35B illustrates an exemplary embodiment of an uncrimped mother stent 3516. Mother stent 3516 includes a circumferential side wall 3518 that forms a lumen 3520. Side wall 3518 includes a side hole opening 3522. The first portion 3524 of the mother stent is disposed distal to one side of the opening 3522 and the second portion 3526 of the mother stent is disposed proximal to another side of the opening.

  FIGS. 35C and 35D illustrate placement of the daughter delivery catheter 3530 and the mother delivery catheter 3540 relative to the mother stent 3516 prior to crimping the mother stent. In many embodiments, the daughter delivery catheter 3530 is delivered first through the side hole and under the proximal portion of the uncrimped mother stent 3516, as illustrated in FIG. 35C. Daughter delivery catheter 3530 includes an elongate shaft 3532 and an expandable member 3534 (eg, an expandable balloon) disposed at the end of elongate shaft 3532. In many embodiments, the daughter delivery catheter 3530 is positioned distal to the mother stent 3516 with the expandable member 3534 uncrimped, and an elongated shaft 3532 passes through the lumen 3520 and the opening of the uncrimped mother stent 3516. Installed to be sent through portion 3522.

  The mother delivery catheter 3540 is then delivered through an uncrimped mother stent 3516, as illustrated in FIG. 35D. Mother delivery catheter 3540 includes an elongate shaft 3542 and an expandable member 3544 (eg, an expandable balloon) disposed at the end of the elongate shaft 3542. The expandable member 3544 is preferably placed within the lumen of the mother stent for subsequent expansion after deploying the mother stent. The mother stent can then be crimped to secure the mother stent to the expandable member 3544 and to loosely secure the daughter delivery catheter 3530 to the mother stent, while the expandable member 3544's Prior to expansion, it still allows slidable movement therebetween (eg, slidably positioned relative to the mother stent). This ensures that the mother stent is not released during delivery through the vasculature, but still allows the daughter catheter to be advanced or retracted relative to the mother catheter prior to balloon inflation.

  35E and 35F schematically illustrate cross sections AA and BB of FIG. 35D, respectively. In cross-section A-A, the mother delivery catheter expandable member 3544 is placed into the lumen through the first portion 3524 of the mother stent, and the elongated shaft 3532 of the daughter delivery catheter is outside of the first portion 3524. Be placed. In section B-B, both the mother delivery catheter expandable member 3544 and the daughter delivery catheter elongate shaft 3532 are positioned through the mother stent second portion 3526 and into the lumen.

  FIGS. 35G-35J schematically illustrate a method for crimping a first portion 3524 of a mother stent to an expandable member 3544 of a mother delivery catheter, according to many embodiments. First, the first portion 3524 of the mother stent, and the corresponding portion of the mother delivery catheter expandable member 3544 (shown unexpanded) are located within the crimp tool 3550 as illustrated in FIG. 35G. Installed. The adjacently disposed portion of the daughter delivery catheter is routed outside the crimp tool (eg, by deflecting the daughter delivery catheter by a sufficient amount). The crimp tool 3550 can include a contraction iris that is operable to contract symmetrically and deform the stent symmetrically inward. Other crimp tools and fixtures known to those skilled in the art can be used. Next, the crimp tool 3550 is contracted to near the final diameter used to crimp the first portion 3524, as illustrated in FIG. 35H. In this configuration, at least one of the expandable member 3544 or the first portion 3524 can be heated to a temperature in the range of, for example, about 50 degrees Celsius to about 65 degrees Celsius. For at least some expandable members 3544, keeping the temperature below 70 degrees Celsius avoids inducing permanent changes in the expandable member (eg, loss of shape memory of the expandable balloon member). Can be helpful. Next, the crimp tool 3550 is contracted to the final diameter used during crimping of the first portion 3524, as illustrated in FIG. 35I. Next, the expandable balloon 3544 is inflated to a pressure in the range of about 50 psi to about 100 psi, as illustrated in FIG. Maintained for 1-2 minutes, for example, such that the expandable balloon can protrude at least partially into the opening in the sidewall of the first portion. Such partial implantation of the first portion 3524 into the expandable balloon 3544 creates an increased retention force between the mother stent and the mother delivery catheter, particularly during delivery through the vasculature. It can be used to prevent inadvertent movement or release of the mother stent relative to the mother delivery catheter prior to deployment of the mother stent.

  Once crimped, the mother delivery catheter can be leak tested before expanding the crimp tool. For example, a vacuum pressure can be applied to the expandable member and the resulting flow measurement can be obtained and used to detect leaks. Similarly, a positive pressure can be applied to the expandable member and the resulting flow measurement can be obtained and used to detect leaks. After the leak test, the crimp tool can be expanded and the partially crimped stent-catheter combination can be removed from the crimp tool.

  FIGS. 35K-35N illustrate a second portion of a mother stent in a combination that includes an expandable member 3544 of a mother delivery catheter and an adjacently disposed portion of a daughter delivery catheter elongate shaft 3532 according to many embodiments. FIG. 6 schematically illustrates a method for crimping 3526. FIG. First, an optional spacer 3552 (eg, Mylar sheet used as a protective sheath) can be placed between the elongate shaft 3532 and the second portion 3526 of the mother stent. The spacer 3552 can be used to prevent the second portion 3526 from being attached to the elongate shaft 3532 as a result of a crimping operation. The spacer is removed after the crimping action, thereby providing an amount of clearance that reduces frictional force when the elongate shaft 3532 is slid relative to the expandable member 3544 of the mother stent and mother delivery catheter. May be. Next, the combination of FIG. 35K is placed in the crimp tool 3550 as illustrated in FIG. 35L. Crimping tools and fixtures known to those skilled in the art can be used. The crimp tool is then contracted to near the final diameter used to crimp the second portion, as illustrated in FIG. 35M. In this configuration, at least one of the expandable member 3544 or the second portion 3526 of the mother stent can be heated to a temperature in the range of, for example, about 50 degrees Celsius to about 65 degrees Celsius. The crimp tool is then deflated to the final diameter used during the second portion crimp, and the expandable balloon is at a pressure in the range of about 50 psi to about 100 psi, as illustrated in FIG. 35N. Inflated to. As shown, each of the elongate shaft and expandable member may be deformed to an oval shape to some extent during the crimping process. The deflated crimp tool configuration can at least partially embed the lower portion of the second portion into the expandable balloon (eg, the expandable balloon is into one or more openings in the lower wall of the second portion. For example, it can be maintained for 1-2 minutes. Such partial implantation of the second portion into the expandable balloon creates an increased retention force between the mother stent and the mother delivery catheter, so that the mother stent relative to the mother delivery catheter prior to deployment of the mother stent. Can be used to prevent inadvertent movement.

  Once crimped, the mother delivery catheter can be leak tested before expanding the crimp tool. For example, a vacuum pressure can be applied to the expandable member and the resulting flow measurement can be obtained and used to detect leaks. Similarly, a positive pressure can be applied to the expandable member and the resulting flow measurement can be obtained and used to detect leaks. After the leak test, the crimp tool can be expanded and the crimped combination can be removed from the crimp tool.

  Once the crimped combination is removed from the crimp tool, the spacer 3552 is removed. To remove the spacer, by pressing the second portion inwardly between the expandable member 3544 and the elongate shaft 3532 to deflect the top of the second portion away from the elongate shaft. , Can help reduce the amount of force required to remove the spacer.

  FIG. 35O schematically illustrates a combined crimp configuration including a mother and daughter delivery catheter and stent, according to many embodiments. As shown, the first portion 3524 of the mother stent (the illustrated distal portion of the mother stent located below the chain line) is fully crimped and at least partially embedded in the balloon. The second portion 3526 of the mother stent is crimped non-uniformly to the expandable balloon, the region below the chain line is fully crimped and at least partially embedded in the balloon, and the region above the chain line is the balloon Is not completely crimped. In many embodiments, the daughter delivery catheter is slidable axially through the lumen and out of the side hole opening of the mother stent.

  FIG. 35P schematically illustrates a cross-section through the second portion 3526 of the mother stent, and further illustrates a portion of the mother stent embedded in the expandable balloon and a mother stent not embedded in the expandable balloon. A part is illustrated. The daughter catheter's elongate shaft is above the expandable balloon of the mother catheter. Because the daughter catheter's elongated shaft profile is smaller than the mother catheter balloon, the mother stent is specifically crimped around the mother catheter balloon and the daughter catheter's elongated shaft. Differential crimps are non-uniform and can form a variety of cross-sectional shapes to accommodate different catheter designs, balloon designs, and stent designs. For example, a pear shape or an 8-shaped configuration is possible. This embodiment is designed to reduce the outer shape as much as possible.

  FIG. 35Q illustrates the cross section BB of FIG. 35D in an alternative embodiment of crimping the stent to the mother catheter. The distal portion 3524 of the stent 3516 is generally crimped to the mother catheter balloon in the same manner as previously described above. However, proximal portion 3526 is crimped to both mother balloon 3544 and daughter catheter shaft 3522 in an 8-shaped configuration. This may be accomplished manually by crimping the daughter catheter shaft 3522 across the upper portion of the stent and then crimping the mother catheter balloon 3544 across the lower portion of the stent. The pinching of the upper part may be controlled so that it is rigid but the daughter catheter shaft may still move under the stent. Similarly, the pinching of the lower portion may also be controlled and is preferably sufficiently tight that the stent is retained on the mother catheter balloon during delivery. The upper part of the figure 8 crimp may have a smaller radius than the lower part of the figure eight crimp due to the smaller outline of the daughter catheter shaft compared to the outline of the mother catheter balloon covering its shaft. . In an alternative embodiment, the figure eight crimp may also be achieved using a crimp tool having a pair of jaws or molds to crimp the stent to the desired configuration.

(Stent delivery (continued))
FIG. 36 illustrates a side view of a mother stent placed on the mother catheter balloon and a daughter catheter placed on the mother catheter through the mother stent. The distal portion of the mother stent is crimped under standard conditions to hold the stent firmly against the mother balloon and mother catheter. The proximal portion of the mother stent is partially crimped to reduce the profile, but still allows the daughter catheter to move freely proximally or distally relative to the mother catheter. This embodiment illustrates that the stent is specifically crimped in both the circumferential and longitudinal directions. The amount of crimp is determined by the design and size of the stent, the dimensions of the catheter, and the dimensions of the balloon, and therefore the crimp varies along the longitudinal axis.

  FIG. 37 illustrates a side view of the mother stent placed on the mother catheter balloon and the daughter catheter placed on the mother catheter through the mother stent. The daughter catheter also includes a stent that can be crimped under standard conditions. The distal portion of the mother stent is crimped under standard conditions to hold the stent firmly against the mother balloon and mother catheter. In one experiment, this arrangement was tested to determine the strength of the distal crimp of the mother stent by pulling the daughter catheter and stent proximally, and the daughter catheter successfully removed the crimped mother stent. The result was that it passed and still retained the daughter stent. Additional features may be utilized during the crimping process, such as applying a slight positive internal pressure so that the final balloon surface exceeds the outer diameter of the stent by about 0.002 inches. This process can result in a design that prevents the stent from engaging the blood vessel, thus reducing friction while improving stent retention.

  In addition, this process improves safety and reduces trauma to the blood vessels. While the above embodiments disclose a bifurcated stent that is crimped in or around its distal half, this is not limiting. Depending on the stent design, the stent can be specifically crimped along its axis, for example if the hole on the side of the stent is not centered along the axis. It may be preferential to extend the distal crimp portion of the bifurcated stent just distal to the hole through which the daughter catheter passes. Alternatively, the distal crimp portion can extend partially or completely over the hole through which the daughter catheter passes.

  38A-38M more clearly illustrate an exemplary method of treating a branch vessel, such as a branch coronary artery. In FIG. 38A, the branch blood vessel BV includes a side branch blood vessel SB and a main branch blood vessel MB. The main branch has a main branch lesion ML, and the side branch has a side branch lesion SL. The angle between the side branch and the main branch is called the branch angle and is indicated by θ. When the bifurcation angle θ is less than about 60-70 degrees, the most distal stent of the system can be effectively placed in the side branch. However, when the bifurcation angle is about 60-70 degrees or more, it becomes more difficult to place the most distal stent in the side branch. Also, when the distal stent is retracted proximally toward a stent having a side hole (discussed below), the catheter shaft binds to the side hole and into the catheter shaft and / or stent. Cause damage. Thus, in a preferred embodiment, when the bifurcation angle is less than about 60-70 degrees, the most distal stent is preferably placed in the side branch and the proximal stent is advanced into the main branch. . When the bifurcation angle is about 60-70 degrees or more, the most distal stent is placed in the main branch and the other stent is partly placed in the main branch and partly in the side branch. Installed. This is not intended to limit the use of the catheter system, depending on the operator's preference, either one of the stents may be placed in either the side branch or the main branch. In FIG. 38B, guide catheter 3802 is advanced distally until its distal end is adjacent to the bifurcation. Then, the pair of guidewires GW1, GW2 is such that the first guidewire GW1 is advanced into the side branch SB and the distal tip of the first guidewire GW1 is distal to the side branch lesion SL And advanced distally from the guide catheter 3802 toward the bifurcation. Similarly, the second guide wire GW2 is also advanced distally in the main branch MB until the distal tip of the second guide wire GW2 is distal to the main branch lesion ML. In FIG. 38C, a stent delivery system having a first catheter 3804 and a second catheter 3824 is advanced distally from the guide catheter 3802 toward the bifurcation. First delivery catheter 3804 includes an elongate catheter shaft 3806 and a radially expandable balloon 3808 disposed over a distal portion of elongate shaft 3806. A balloon expandable stent 3816 is placed over the balloon 3808. In this exemplary embodiment, the stent is shorter than the working length of balloon 3808, and thus proximal portion 3810 and distal portion 3812 of balloon 3808 are not constrained by stent 3816. Proximal portion 3810 may be retracted under a portion of second stent 3842, thus radially expanding stent 3816 and a portion of stent 3842 when balloon 3808 is inflated. However, this is not intended to be limiting and the length of the stent may be substantially equivalent to the working length of the balloon, or, as previously discussed, with a shorter length. There may be. Proximal radiopaque marker 3820 and distal radiopaque marker 3818 help define the proximal and distal ends of stent 3816 and the proximal and distal ends of balloon 3808. Radiopaque markers are also used to help align the two catheters during bifurcation treatment, as discussed below. The distal tip 3814 may be a soft durometer polymer, thereby minimizing trauma to the blood vessel during delivery. Distal guidewire port 3822 extends from distal tip 3814 to allow guidewire GW1 to enter or exit a guidewire lumen (not shown) in elongate shaft 3806. . The first catheter 3804 may be a rapid exchange catheter or an over-the-wire catheter, examples of which are discussed above. The second catheter 3824 (best seen in FIG. 38D) includes an elongate catheter shaft 3826 with a radially expandable balloon 3828 disposed over the distal region of the elongate shaft 3826. A stent 3842 having side holes 3844 is disposed over the balloon 3828. The length of the stent 3842 may be substantially the same as the working length of the balloon 3828 or may be smaller than the working length. In this exemplary embodiment, stent 3842 has a length that is less than the working length of balloon 3828, and thus proximal portion 3830 and distal portion 3832 remain unconstrained by stent 3842. Proximal radiopaque marker 3836 and distal radiopaque marker 3834 help define the proximal and distal ends of stent 3842 and the proximal and distal ends of balloon 3828. Radiopaque markers are also used to help align the two catheters during bifurcation treatment, as discussed below. The distal tip 3838 may be a soft durometer polymer, thereby minimizing trauma to the blood vessel during delivery. Distal guidewire port 3840 extends from distal tip 3838 and allows guidewire GW2 to exit or enter a guidewire lumen (not shown) in elongate shaft 3826. The second catheter 3824 may be a rapid exchange catheter or an over-the-wire catheter, examples of which are discussed above.

  Referring back to FIG. 38C, the bifurcation angle is less than about 60-70 degrees, and the first catheter 3804 and the second catheter 3824 are located in the side branch SB over the first guide wire GW1. While the second catheter 3824 is advanced further distally over the second guidewire GW2 in the main branch MB toward the main branch lesion ML. Since the first catheter 3804 is coupled to the second catheter 3824 via the stent 3842, both catheters are advanced distally simultaneously, thereby reducing the procedure time, but each catheter is in conjunction with the other. This is not intended to be limiting as it may be advanced independently. In this embodiment, the first balloon 3808 and the first stent 3816 are distal to the second balloon 3828 and the second stent 3842. This axial offset minimizes the system profile.

  In FIG. 38D, both catheters 3804 until the first stent 3816 is distal to the side branch lesion SL, the second stent 3842 crosses the main branch lesion ML, and the side hole 3844 is adjacent to the side branch SB port. , 3824 are advanced further distally towards the bifurcation. The advancement of both catheters 3804, 3824 again takes place simultaneously, but can also be advanced independently of each other. As the catheter is advanced further distally, the two catheter shafts 3806, 3826 will expand relative to each other when pushed against the bifurcated ridge, allowing the operator to resist resistance to further advancement of the catheter 3804, 3824. Feel. However, a portion of the first elongate shaft 3806 is disposed below a portion of the second stent 3842, so that the two shafts 3806, 3826 can only extend there. Thus, when the operator feels resistance to further advancement of the catheter shaft, the operator knows that both catheters 3804, 3824 and their associated stents and balloons are properly installed relative to the bifurcation.

  In FIG. 38E, the first catheter 3804 is retracted proximally with respect to the second catheter 3824. Since a portion of the first catheter shaft 3806 is disposed below a portion of the second stent 3842, the first shaft 3806 is slidably retracted into the side hole 3844 and the first shaft 3806 and proximal portion 3810 of balloon 3808 are slidably retracted under a portion of second stent 3842. The first shaft has a proximal radiopaque marker 3820 aligned with a proximal radiopaque marker such that the proximal end of the first stent 3816 is aligned with the side hole 3844 of the second stent 3842. It is retracted proximally until it coincides with 3836. The operator may feel resistance during retraction of the first elongate shaft 3806 relative to the second elongate shaft 3826 as the ends of the stents 3816, 3842 engage each other. The stent 3842 has a distal portion that is crimped to the balloon 3828 to prevent release during delivery, and the proximal portion includes a portion that allows the catheter 3804 to slide thereunder. Either crimped or not crimped. The ends of the stent may be adjacent to each other, overlap with each other, interleaved with each other, or a combination thereof. Additional details related to stent engagement are disclosed in previously incorporated US patent applications, referenced above. Both stents 3816, 3842 are positioned adjacent to the respective lesions SL, ML, and the side holes 3844 are substantially aligned with the side branch SB port and the side branch stent 3816.

  In FIG. 38F, the balloon 3808 is radially expanded so that often the contrast agent, saline, or a combination thereof expands the first stent 3816 to engage the side branch lesion SL and the side branch wall. Let The proximal portion 3810 and the distal portion 3812 of the balloon 3808 are also expanded, and thus the proximal portion of the second stent 3842 is also radially expanded. Stent expansion occurs simultaneously. Since a portion of the balloon 3808 also passes through the side hole 3844, expansion of the balloon 3808 also partially expands the side hole 3844 and aligns the side hole 3844 with the side branch.

  In FIG. 38G, balloon 3808 is deflated, and then in FIG. 38H, the other balloon 3828 is radially expanded so that contrast agent, saline, or a combination thereof causes second stent 3842 to move. Further expand in the radial direction. Expansion of the balloon 3828 expands the proximal portion of the stent 3842 to engage the main branch vessel wall and main branch lesion ML, and the distal portion of the stent 3842 also extends into the main branch vessel wall and the main branch lesion ML. Is expanded radially. The side hole 3844 is also further aligned with the side branch SB port.

  Referring now to FIG. 38I, the balloon 3828 is deflated and then both balloons are inflated simultaneously with the “contact balloon” technique as seen in FIG. 38J. Both balloons 3808, 3828 are inflated with contrast agent, saline, or a combination thereof so that they engage each other and are fully expanded in the main branch MB and the side branch SB. The contact balloon technique ensures that both stents 3816, 3842 are fully expanded and fully juxtaposed with their respective vessel walls and lesions. In addition, the contact balloon technique aligns the proximal end of the first stent 3816 with the side hole 3844 of the second stent 3842, thereby providing a continuous and smooth scaffold from the main branch MB into the side branch SB. Secure. The contact balloon technique also ensures that the side holes do not block the opening to the side branch, thereby avoiding “stent detention” or blockage of blood flow into the side branch.

  In FIG. 38K, both balloons 3808, 3828 are deflated, and in FIG. 38L, both catheters 3804, 3824 are retracted proximally. The catheters may be retracted simultaneously or independently of each other. The first catheter 3804 is retracted through both stents 3816, 3842 and passes through the side hole 3844. Second catheter 3824 is retracted through second stent 3842. In FIG. 38M, both catheters 3804, 3828 and guide catheter 3802 and both guidewires GW1, GW2 have been removed. Stents 3816, 3842 remain embedded in the bifurcation. Optionally, the stent or balloon may contain therapeutic agents, such as those previously discussed, which will elute into the lesion at a controlled rate to help prevent restenosis. May be.

  39A-39M more clearly illustrate another exemplary embodiment of a method for treating a branch vessel. This method is similar to that previously disclosed, the main difference being that the most distal catheter is used to treat the main branch vessel and the proximal catheter is used to treat the side branch vessel That is. In previous embodiments, the most distal catheter is used to treat the side branch vessels and the proximal catheter is used to treat the main branch.

  In FIG. 39A, the branch blood vessel BV includes a side branch blood vessel SB and a main branch blood vessel MB. The main branch has a main branch lesion ML, and the side branch has a side branch lesion SL. The angle between the side branch and the main branch is called the branch angle and is indicated by θ. When the bifurcation angle θ is less than about 60-70 degrees, the most distal stent of the system can be effectively placed in the side branch. However, when the bifurcation angle is about 60-70 degrees or more, it becomes more difficult to place the most distal stent in the side branch. Also, when the distal stent is retracted proximally toward a stent having a side hole (discussed below), the catheter shaft binds to the side hole and into the catheter shaft and / or stent. Cause damage. Thus, in a preferred embodiment, when the bifurcation angle is less than about 60-70 degrees, the most distal stent is preferably placed in the side branch and the proximal stent is advanced into the main branch. . When the bifurcation angle is about 60-70 degrees or more, the most distal stent is placed in the main branch, and the other stent is partly placed in the main branch and partly in the side branch. Installed. This is not intended to limit the use of the catheter system, depending on the operator's preference, either one of the stents may be placed in either the side branch or the main branch. In FIG. 39B, guide catheter 3902 is advanced distally through the blood vessel until adjacent to bifurcation and lesions ML, SL. The first guide wire GW1 is advanced distally through the main branch MB until it is distal to the main branch lesion ML. The second guidewire also enters the side branch SB and is advanced distally until it is distal to the side branch lesion SL.

  In FIG. 39C, a treatment system having a first catheter 3904 and a second catheter 3924 is advanced distally through the guide catheter 3902 toward the bifurcation. The two catheters 3904, 3924 may be advanced independently of each other, or the two catheters may preferably be advanced simultaneously. The first delivery catheter 3904 includes an elongate shaft 3906 having a radially expandable balloon 3908 on the elongate shaft 3906. A stent 3922 is placed over the balloon 3908. The length of the stent 3922 may substantially match the working length of the balloon 3908, or the length of the stent 3922 may be such that the proximal portion 3910 and the distal portion 3912 of the balloon remain unconstrained by the stent 3922. As is the case, the working length of the balloon 3908 may be smaller. Proximal radiopaque marker 3916 and distal radiopaque marker 3914 are used to help determine the proximal and distal ends of balloon 3908 and the proximal and distal ends of stent 3922. May be. A soft durometer polymer tip may be used on the distal portion of the catheter shaft 3906 to prevent trauma to the vessel being delivered, the catheter shaft 3906 having a guidewire GW1 in the catheter shaft 3906. A distal guidewire port 3920 is provided to allow entry into or exit from a lumen (not shown). The first catheter 3904 may be a rapid exchange catheter or may be an over-the-wire catheter. The second catheter 3924 (best seen in FIG. 39D) includes an elongate shaft 3926 having a radially expandable balloon 3928 on its distal portion. The second stent 3934 is placed over the second balloon 3928. The length of the stent may substantially match the working length of the balloon or may be smaller. In this exemplary embodiment, the length of the stent 3934 is less than the working length of the balloon 3928, so that the proximal and distal portions 3930 and 3940 of the balloon remain unconstrained by the stent 3934. A portion of the first elongate shaft 3906 is disposed below the proximal portion of the second stent 3934, and the stent 3934 also has a side hole 3936 so that the first elongate shaft 3906 can be withdrawn therefrom. . The first elongate shaft 3906 may slide under the stent 3934 relative to the second elongate shaft 3926, and thus the proximal portion 3910 of the balloon 3908 is also disposed under the stent 3934. As balloon 3908 is expanded, the proximal portion of stent 3934 is also expanded. Second catheter shaft 3926 also has proximal radiopaque markers 3932 and distal radiopaque to help identify the proximal and distal ends of balloon 3928 and the proximal and distal ends of stent 3934. A transparent marker 3938 is included. The second catheter 3924 also has a soft durometer polymer tip 3942 that helps minimize trauma to the blood vessel during delivery, and the distal guidewire port 3944 has a guidewire guide in the elongated shaft 3926. Allows insertion into or withdrawal from a wire lumen (not shown). The second catheter 3924 may be an over-the-wire catheter or may be a rapid exchange type. First stent 3922 and balloon 3908 are distal to second stent 3939 and second balloon 3928.

  In FIG. 39D, the branching angle θ is greater than about 60 to 70 degrees. The first stent 3922 is distal to the main branch lesion ML, the second stent 3934 is partially disposed in the side branch SB adjacent to the side branch lesion SL, and the stent 3934 is also adjacent to the main branch lesion ML. Thus, both catheters 3904, 3924 are advanced further distally toward the bifurcation until they are placed in the main branch MB. The side holes 3936 also generally face in the direction of the main branch vessel MB. The advancement of both catheters is preferably done simultaneously, but can also be advanced independently of each other. As the catheter is advanced further distally, the two catheter shafts 3906, 3926 expand relative to each other as they are pushed against the bifurcated ridge so that the operator can resist resistance to further advancement of the catheter 3904, 3924. Feel. However, a portion of the first elongate shaft 3906 is disposed below a portion of the second stent 3934, so that the two shafts 3906, 3926 can only extend there. Thus, when the operator feels resistance to further advancement of the catheter shaft, the operator knows that both catheters 3904, 3924 and their associated stents and balloons are properly installed relative to the bifurcation.

  In FIG. 39E, the first catheter 3904 is retracted proximally with respect to the second catheter 3924 so that the proximal portion 3910 of the balloon 3908 is positioned under the stent 3934. Stent 3934 has a distal portion crimped to balloon 3928 to prevent release during delivery, and the proximal portion allows shaft 3906 to slidably pass underneath. , Partially crimped on balloon 3928 or not crimped. Because a portion of the first catheter shaft 3906 is disposed below a portion of the second stent 3934, the first shaft 3906 is slidably retracted into the side hole 3936 and the first shaft 3906 is also slidably retracted under a portion of the second stent 3934. The first shaft has a proximal radiopaque marker 3916 aligned with a proximal radiopaque marker such that the proximal end of the first stent 3922 is aligned with the side hole 3936 of the second stent 3934. It is retracted proximally until it coincides with 3932. The operator may feel resistance during retraction of the first elongate shaft 3906 relative to the second elongate shaft 3926 as the ends of the stents 3922, 3934 engage each other. The ends of the stent may be adjacent to each other, overlap with each other, interleaved with each other, or a combination thereof. Additional details related to stent engagement are disclosed in US patent applications previously incorporated by reference above. Both stents 3922, 3934 are positioned adjacent to their respective lesions SL, ML, and the side holes 3936 are substantially aligned with the main branch vessel MB.

  In FIG. 39F, the balloon 3908 is radially expanded so that often the first stent 3922 so that contrast agent, saline, or a combination thereof engages the main branch lesion ML and the main branch wall. To expand. The proximal portion of the second stent 3934 is also expanded to engage the main branch lesion ML and the main branch wall, while the distal portion of the second stent 3934 is not expanded in the side branch SB. The state remains. The proximal portions of the first stent 3922 and the second stent 3934 are simultaneously radially expanded. The inner surfaces of both stents form a smooth lumen for blood flow through the main branch. Since a portion of the balloon 3908 also passes through the side hole 3936, the expansion of the balloon 3908 also partially expands the side hole 3936 and aligns the side hole 3936 with the main branch lumen.

  In FIG. 39G, balloon 3908 is deflated, and in FIG. 39H, the other balloon 3928 is radially expanded so that contrast agent, saline, or a combination thereof is second stent 3934. Is further expanded radially. Expansion of the balloon 3928 expands the distal portion of the stent 3934 to engage the side branch vessel wall and the side branch lesion SL. The proximal portion of the stent 3934 and the side holes 3936 may also be further expanded and aligned with the first stent 3922. The side holes are also further aligned with the lumen of the main branch.

  Referring now to FIG. 39I, balloon 3928 is deflated and then both balloons are inflated simultaneously with the “contact balloon” technique as seen in FIG. 39J. Both balloons 3908, 3928 are inflated with contrast agent, saline, or a combination thereof so that they engage each other and are fully expanded in the main branch MB and the side branch SB. The contact balloon technique ensures that both stents 3922, 3934 are fully expanded and fully juxtaposed with their respective vessel walls and lesions. In addition, the contact balloon technique aligns the proximal end of the first stent 3922 with the side hole 3936 of the second stent 3934, thereby providing a continuous and smooth scaffold from the main branch MB into the side branch SB. Secure. The alignment of the two stents is disclosed in more detail in the US patent application previously incorporated by reference above. The contact balloon technique also ensures that the side holes do not block turbulent blood flow across the main branch or branch.

  In FIG. 39K, both balloons 3908, 3928 are deflated, and in FIG. 39L, both catheters 3904, 3924 are retracted proximally. The catheters may be retracted simultaneously or independently of each other. The first catheter 3904 is retracted through both stents 3922, 3934 and passes through the side hole 3936. The second catheter 3924 is retracted through the second stent 3934. In FIG. 39M, both catheters 3904, 3924, and guide catheter 3802 and both guide wires GW1, GW2 have been removed. Stents 3922, 3934 remain embedded in the bifurcation. Optionally, the stent or balloon may contain therapeutic agents such as those previously discussed, which will elute into the lesion at a controlled rate to help prevent restenosis. May be.

  Any of the methods described above may use any of the stents disclosed herein in any of the described system configurations. In addition, any of the features previously described above may be used. Thus, those skilled in the art will understand that any number of combinations may be made. For example, the catheter system can be used with or without a therapeutic agent on a stent or balloon and with or without any of the hollow exchange ports, capture tubes, removable capture tubes, or snap fittings described above. Rather, it may have any combination of rapid exchange or over-the-wire configurations with any of the stents disclosed herein.

(Stent)
The catheter systems and methods described above may use commercially available stents for the proximal or distal stents in the system. When a commercially available stent is used for a distal stent, it need only be crimped to a distal balloon catheter. When a commercially available stent is used for a proximal stent, it is such that a portion of the second catheter shaft is slidably disposed under the stent and a portion of the second catheter shaft slides through the side holes of the stent. It may be partially crimped to the proximal balloon to allow it to pass. The stent is crimped to the proximal balloon so that it is not displaced from the balloon during delivery and so that the second catheter shaft can slide under it. FIGS. 40A-40E illustrate some examples of commercially available stents that may be used in the catheter system configuration and method described above as is or with minor modifications. For example, FIG. 40A illustrates an Abbott Vacicular Xience® drug eluting stent 4102a. A portion of the catheter shaft may be placed under the stent through its central channel and the catheter may exit the side hole of the stent. The side holes may be gaps 4104a created between adjacent struts in a cell, or gaps 4106a between axially adjacent cells. FIG. 40B illustrates a Cordis Cypher® stent 4102b. Again, a portion of the catheter shaft may be placed under the stent through its central channel, and the catheter may exit the side hole of the stent. The side holes may be gaps 4104b created between adjacent struts in a cell, or gaps 4106b between axially adjacent cells. FIG. 40C illustrates a Boston Scientific Taxus® Liberte® stent 4102c. A portion of the catheter shaft may be placed under the stent through its central channel and the catheter may exit the side hole of the stent. The side holes may be gaps 4104c created between adjacent struts in a cell, or gaps 4106c between axially adjacent cells. FIG. 40D illustrates a Medtronic Endeavor® stent 4102d. A portion of the catheter shaft may be placed under the stent through its central channel and the catheter may exit the side hole of the stent. The side hole may be a gap 4104d created between adjacent struts in a cell, or a gap 4106d between axially adjacent cells. FIG. 40E illustrates a Palmaz-Schatz® stent 4104e. A portion of the catheter shaft may be placed under the stent through its central channel and the catheter may exit the side hole of the stent. The side holes may be gaps 4104e created between adjacent struts in a cell or gaps 4106e between axially adjacent cells. Other stents specifically designed to treat bifurcations are designed with side holes. These stents may also be used with the systems and methods disclosed herein. For example, FIGS. 40F-40H illustrate several embodiments of stents from Boston Scientific and are disclosed in detail in US Pat. No. 7,678,142. FIG. 40F shows stent 4102f after it has been widened and flattened with side holes 4106f. 40F provides a stent geometry (an unfolded plan view) that creates a side hole 4106f that allows the struts to access the side branch and accommodate the catheter shaft as described herein. Illustrated. The side holes may be formed by spaces 4104f and 4108f between the columns. FIG. 40G illustrates a stent geometry (unfolded plan view) with side holes 4106g. Alternatively, the side holes may be formed by spaces 4104g, 4108g between struts or axial connectors. FIG. 40H illustrates yet another stent geometry (unfolded top view) with side holes 4106h. The side holes may also be formed by spaces between the posts 4104h or the axial connectors 4108h. In any of these embodiments, the catheter shaft may be slidably disposed under a portion of the stent, and the catheter shaft may exit the side hole. In addition, any of the stents or balloons disclosed herein may carry therapeutic agents such as those described above for local drug delivery. Also, the stents disclosed herein are preferably balloon expandable, although those skilled in the art will recognize that self-expanding and hybrid balloon expandable / self-expanding stents may also be used. You will understand.

(Stent alignment)
42A-42C illustrate various ways in which a side branch stent can be matched with a main branch stent. In FIG. 42A, the side branch SB is substantially perpendicular to the main branch MB, and therefore the branch angle θ is about 90 degrees. In this situation, the proximal end 4206 of the side branch stent 4202 is substantially flush with the side hole 4208 of the main branch stent 4204 (assuming proper deployment of both stents). This is desirable because there is no gap and thus there is no area of scaffold between the two stents 4202, 4204. However, as the branch angle θ increases (FIG. 42B) or decreases (FIG. 42C), a portion of the side branch remains unstented. For example, in FIG. 42B, due to the right columnar shape of the stent where the bifurcation angle is increased and the ends are perpendicular to the stent sidewalls, the gap 4210 is formed between the proximal end 4206 of the side branch stent 4202 and the main branch stent 4204. It exists between the side holes 4208. Similarly, in FIG. 42C, when the bifurcation angle is reduced, there is also a gap 4212 between the proximal end 4206 of the side branch stent 4202 and the side hole 4208 of the main branch stent 4204. FIG. 42C is typical for anatomy, so the gap 4212 is often upstream of the bifurcation. The gap is undesirable because there is no scaffold and recoil or restenosis may occur in this region. In addition, when the stent is used for drug elution, the gap region does not receive any of the drug.

  One possible solution to ensure that the gap between the side branch stent and the main branch stent is eliminated or reduced is shown in FIG. 43A. The side branch stent 4302 is a right cylindrical stent. The main branch stent 4304 has side holes 4306 with struts that extend outwardly into the gap region, thereby ensuring a continuous scaffold. The alternative solution of FIG. 43B is to use a side branch stent 4308 such that its proximal end is not perpendicular to the central axis of the stent so that the proximal end of the side branch stent coincides with the side hole of the main branch stent 4312. Producing the proximal end 4310. Even when using the geometry illustrated in FIGS. 43A-43B, it still requires careful alignment of the side branch stent with the main branch side hole. Accordingly, it is desirable to provide a stent geometry that facilitates alignment.

  The ends of the side branch stent and main branch stent may intersect in several different ways, thereby providing a continuous and uniform covering of the branches. For example, in FIG. 44, the portion 4406 of the side branch stent 4402 may be placed inside the main branch stent 4404. FIG. 45 shows a portion 4506 of the main branch stent 4504 positioned inside the side branch stent 4502. Neither the situation of FIG. 44 or 45 is ideal, since overlapping stents can cause metal friction on the metal and possibly disturb blood flow or cause stagnation points. A more desirable interface between the stents is when the end of the side branch stent 4602 is adjacent to the side hole of the main branch stent 4604 and is shown in FIG. The interfacial region 4606 is desirable because it provides a continuous scaffold of blood vessels with no gaps between the ends of the stent. However, depending on the geometry of the stent, gaps may still exist between the stents. Thus, in a preferred embodiment, the ends of the stent are interleaved or interdigitated with each other.

  47A-47D illustrate several exemplary embodiments in which the ends of the side branch stent and the side holes of the main branch stent are interleaved or interdigitated with each other. For example, in FIG. 47A, the proximal end 4704 of the side branch stent 4702 is interdigitated or interleaved with laterally extending elements or fingers 4716 that extend laterally from the side holes 4708 of the main branch stent 4706. And has a series of axially extending elements or fingers 4712. FIG. 47B illustrates an exemplary embodiment of interdigitated axial and transverse elements. The proximal end 4704 of the side branch stent 4702 has a plurality of axially extending elements 4712. The axially extending element 4712 is formed from a plurality of interconnected stent struts 4714, in this case forming a triangle. Similarly, the side hole 4708 of the main branch stent 4706 has a plurality of laterally extending elements 4716 formed from a plurality of interconnected stent struts 4718. In this case, the laterally extending element 4716 is formed in a triangle. Thus, the apex of one triangular element fits between adjacent elements on adjacent stents. Or alternatively, the vertices fit into a valley and the valley accepts the vertex.

  FIG. 47C illustrates another exemplary embodiment of an interleaved or interdigitated element. Proximal end 4704 of side branch stent 4702 includes struts 4720 formed in a series of apexes and valleys. Similarly, the side hole 4708 of the main branch stent 4706 also has struts 4722 formed in a series of apexes and valleys. Thus, the apex of the side branch stent fits into the valley of the side hole of the adjacent main branch stent, and similarly, the valley of the side branch stent receives the apex of the side hole. FIG. 47D illustrates yet another exemplary embodiment of interleaved or interdigitated stent ends. Proximal end 4704 of side branch stent 4702 includes struts 4724 formed in a series of rectangular vertices and valleys. Side hole 4708 of main branch stent 4706 also includes struts 4726 formed between a series of rectangular vertices and valleys. Vertices and valleys are interleaved or interdigitated with each other.

(Balloon configuration)
The balloon used to radially expand the stent described herein may be a cylindrical balloon having a constant diameter along the working length, or the diameter may vary. . When stenting a tapered vessel, it may be advantageous to use a balloon with a variable diameter balloon that more closely matches the vascular structure. For example, in FIG. 41A, a tapered balloon 5006 is attached to the distal portion of the shaft 5002. A soft durometer tip 5004 prevents vascular trauma during delivery. The balloon is tapered such that the balloon proximal portion 5010 has a larger diameter than the distal portion 5006. Any taper may be used. FIG. 41B illustrates another embodiment of a balloon 5012 having a plurality of stepped regions 5014. The step region may be incremented by any amount, and in a preferred embodiment, the balloon proximal portion 5016 has a larger diameter than the distal portion 5018. Any of these embodiments, or combinations thereof, may be used with the systems and methods described herein to treat bifurcation. The use of a tapered or stepped balloon allows the stent to be expanded to more closely match the vessel wall, with the proximal portion of the expanded stent having a larger diameter than the distal portion of the stent.

  In addition to using a rapid exchange or over-the-wire guidewire lumen and a catheter with a tapered or stepped balloon, the balloon catheter may not always utilize the guidewire lumen. Alternatively, a fixation wire may be attached to the distal end of the catheter. For example, FIG. 48 illustrates an exemplary embodiment of a fixed wire catheter 5102 having a balloon 5106 attached to the distal portion of the shaft 5104. A portion of the guide wire 5108 is fixedly attached to the distal end of the catheter, which helps to track the catheter through the blood vessel. The fixation wire may have any number of shapes including straight lines, curved lines, J-shaped tips, and the like. This embodiment may be used with any of the systems and methods disclosed herein, or may or may not have a stent crimped to a balloon. Fixed wire catheters may be used in the main branch, or more preferably in the side branch.

  While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims.

Claims (27)

A system for crimping a stent on an expandable member of a delivery catheter, the system comprising:
And it is configured to be placed extended member on, a stent having a second end of the first end and the most proximal and most distal, first and second portions Each extending between the most distal first end and the most proximal second end, the stent including a sidewall through which a side hole extends;
The stent is configured to be crimped non-uniformly to the expandable member, the expandable member between the most distal first end and the most proximal second end. and outermost also comprise a delivery balloon extending beyond both the second end of the first end and the outermost also proximal of the distal, the stent is only a segment of the second portion is embedded in the delivery balloon as, unevenly crimped, and the second portion, as the second portion is left in a state that is not crimped to the delivery balloon over a portion of the delivery balloon, the delivery balloon A stent that is partially crimped to
An elongate shaft configured to be fed through the side hole under the second portion of the stent to be routed outside the first portion;
A spacer configured to be placed between a portion of the elongate shaft and a portion of the second portion of the stent;
A portion of the second portion of the stent is configured to be crimped into contact with the spacer;
The spacer is configured to be removed from between a portion of the elongate shaft and a portion of the second portion of the stent , the elongate shaft being attached to the stent prior to deployment of the stent. And a spacer, slidably disposed with respect to the second portion. Said first portion, said uniform crimped to the delivery balloon, the second portion is unevenly crimped to the delivery balloon, the system according to claim 1.   The system of claim 2, wherein the first portion of the stent is crimped uniformly circumferentially and longitudinally along itself.   The system of claim 2, wherein the second portion of the stent is crimped non-uniformly circumferentially along itself.   The system of claim 1, wherein the first portion is disposed distal to the side hole and the second portion is disposed proximal to the side hole.   The system of claim 1, wherein the first portion is crimped using a constriction opening. The stent includes a side wall through which a plurality of openings penetrates;
The system of claim 1, wherein the delivery balloon projects at least partially into one or more of the openings. The system of claim 7, wherein the delivery balloon is configured to be partially inflated before or when the stent is crimped. The system of claim 8, wherein the delivery balloon is inflated to a pressure in the range of about 50 psi to about 100 psi when the stent is crimped. 8. The system of claim 7, wherein at least one of the delivery balloon or the stent is configured to be heated before the stent is crimped or when the stent is crimped.   The system of claim 10, wherein the at least one expandable member or stent is heated to a temperature in the range of about 50 degrees Celsius to about 65 degrees Celsius.   The system of claim 1, wherein a vacuum pressure is configured to be applied to the expandable member. The system of claim 1, wherein the delivery balloon is configured to be at least partially inflated. The second portion is configured to be partially crimped to the delivery balloon , thereby enabling slidable movement of an elongate shaft under the second portion. The system described in.   The system of claim 1, wherein the first portion and the second portion are crimped while still allowing an elongate shaft to slidably pass through the side hole.   The system of claim 1, wherein the second portion of the stent is crimped using a shrink port. The second portion of the stent includes a sidewall through which a plurality of openings extend;
The system of claim 1, wherein the expandable member projects at least partially into one or more of the openings. At least one of the expandable member or the second portion of the stent is heated before the second portion of the stent is crimped or when the second portion of the stent is crimped. The system of claim 1, configured as follows. 19. The system of claim 18, wherein at least one of the delivery balloon or the second portion of the stent is heated to a temperature in the range of about 50 degrees Celsius to about 65 degrees Celsius.   The system of claim 1, wherein the spacer includes a protective sheath. Wherein the delivery balloon, when the second portion of the front or the stent second portion of the stent is crimped is crimped, and is configured to be inflated partially, to claim 1 The described system.   The system of claim 1, further comprising a portion of a second portion of the stent configured to be crimped into contact with the elongate shaft.   24. The system of claim 22, wherein the elongate shaft is slidably disposed with respect to a second portion of the stent after deployment of the stent. The system of claim 1, wherein a portion of the second portion is not crimped to a portion of the delivery balloon .   The system of claim 1, wherein the stent is coated with a therapeutic agent.   26. The system of claim 25, wherein the therapeutic agent prevents restenosis.   The system of claim 1, wherein the entire first portion of the stent is embedded in the delivery balloon.

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