CN1171565C - Delivery system for branched implant films - Google Patents

Abstract

An endovascular liner comprising a 1 st tubular passageway and a 2 nd tubular passageway, the 1 st tubular passageway comprising a 1 st distal end and a 1 st proximal end, the 2 nd tubular passageway comprising a 2 nd distal end and a 2 nd proximal end, wherein the 2 nd distal end of the 2 nd tubular passageway is secured to the 1 st tubular passageway adjacent the 1 st distal end to define: i) a junction immediately adjacent to a bifurcation in a branching body passageway, ii) an extension in the 1 st tubular passageway distal to the junction for insertion into one of the 1 st and 2 nd body passageways. It can be used to guide a pair of guide wires to a branched body duct so that, once in place, the guide wires are substantially untwisted, i.e. not tangled. This greatly facilitates delivery of the branched stent membrane to the branched artery.

Description

Delivery system for branched implant membranes

The technical field of the present invention

The present invention relates to an endovascular liner for delivering branch implants. In another aspect, the invention relates to a delivery kit for branch implants. In yet another aspect, the invention relates to methods of delivery of branched implants.

Background technology related to the present invention

Implanted membranes are well known. In fact, the term "implant" is used interchangeably with terms such as "endovascular graft" and "expandable prosthesis". The term "implantation membrane" is used throughout this specification to have a broad meaning and encompass any expandable prosthetic device intended for implantation within a passageway to the body, such as a lumen or artery.

The use of implanted membranes has attracted increasing attention over the past decade due to the potential for the use of these devices as an alternative to surgery in some settings. Typically, an implanted membrane is used to obtain and maintain the patency of the body passage while maintaining the integrity of the body passage. As used in this specification, the term "body passage" is intended to have a broad meaning covering any conduit (natural and iatrogenic) in the human body, and may include blood vessels, respiratory tracts, gastrointestinal tracts, and any kind of pipeline.

Implants have been developed to such an extent that the vast majority of currently available implants rely on controlled plastic deformation of their overall structure on the body passageway target such that only the Sufficient force to maintain the unimpeded passage of the body.

Typically, in many of these systems, an implanted membrane-bound balloon is delivered by a catheter system to the target area of the bodily passage. Once the implant is properly positioned (e.g., can be filled with contrast agent to be seen on a see-through screen for the purpose of endovascularly grafting a vessel), the balloon is inflated to plastically deform the overall structure of the implant , thereby fitting the latter against the body channel. As noted above, the amount of force applied must at least expand the implant membrane (ie apply a force that exceeds the minimum force that the implant membrane material can withstand plastic deformation) while maintaining the body passageway open. At this point, the balloon is deflated and withdrawn from the catheter, then removed. Ideally, the implanted membrane will stay in place, substantially precluding blockage (or stenosis) of the targeted area of the bodily passage.

For example, see the following patents:

US Patent 4,733,665 (Palmaz),

US Patent 4,739,762 (Palmaz),

US Patent 4,800,882 (Gianturco),

US Patent 4,907,336 (Gianturco),

US Patent 5,035,706 (Gianturco et al.),

US Patent 5,037,392 (Hillstead),

US Patent 5,041,126 (Gianturco),

US Patent 5,102,417 (Palmaz),

US Patent 5,147,385 (Beck et al.),

US Patent 5,282,824 (Gianturco),

US Patent 5,316,023 (Palmaz et al.),

Canadian Patent 1,239,755 (Wallsten),

Canadian Patent 1,245,527 (Gianturco et al.),

Canadian Patent Application No. 2,171,047 (Penn et al.),

Canadian Patent Application No. 2,175,722 (Penn et al.),

Canadian Patent Application No. 2,185,740 (Penn et al.),

Canadian Patent Application No. 2,192,520 (Penn et al.),

International Patent Application PCT/CA97/00151 (Penn et al.),

International Patent Application PCT/CA97/00152 (Penn et al.), and

The content of each of them is hereby incorporated by reference for discussions pertaining to the aforementioned implant membrane designs and deployment systems.

In the above-mentioned patents, the implanted membranes discussed all share a common single-tube design and are thus best suited for direct delivery and placement in body passages. Such well-known implant membranes are not suitable for use in branching body passages, for example a body passage comprising a parent passage that splits into a pair of passages. Also, such implants are unsuitable for body passages with side branches because: (i) inaccurate placement of the implants significantly increases risk to the patient, (ii) increases risk of closure of side branch passages, and (iii) Side branch passages will not actually be accessible.

Indeed, in a 32-page statement published in the Physician's Guidelines in Support of the Palmaz-Schatz Implantable Membrane (the contents of which are hereby incorporated by reference):

“There was no attempt to place the PALMAZ-SCHATZ implant into the side branch using a guide wire or balloon, as such attempts could result in additional damage to the target vessel or the implant. Attempts to address occlusion in the implant segment The side branch could have pinched the balloon necessitating emergency surgical bypass."

For example, when installed, the PALMAZ-SCHATZ Implant Membrane may permanently completely obscure side branches emanating from the body channel target area. This can be problematic because the only way to deal with blockages or other problems with side branches is to perform the type of surgery that avoids the installation of implants.

Contraindications to conventional single-catheter implants have been confirmed by a large number of investigators. See for example:

1. Interventional Cardiovascular Medicine: Principles and Practice (1994); Publisher: Churchill Livingstone Inc.; Pages 221-223 (Ohman et al.), 667-668 (Bashore et al.) and 897 (Bailey et al. .), including references cited herein;

2. Gianturco-Roubin Buckling ^- ImplantTM Coronary Implant Membrane; Physician's Guide; Page 2, Warning under paragraph 3;

3. Circulation, Vol. 83, No. 1, January 1991 (Schatz et al.); title "Clinical Experience with Palmaz-Schatz Coronary Implants"; pp. 149 of 148-161; and

4. American Heart Journal, Vol. 127, No. 2, February 1994 (Eeckhout et al.); Title "Complications and Outcomes After Intracoronary Implantation: A Critical Analysis of One Center's Six-Year Experience"; Page 263 of 262-272, the contents of each of which are hereby incorporated by reference.

Furthermore, some investigators have attempted to install separate implants in each branch of the branching body passages. However, this approach comes with at least two significant problems. First, the grafting of the three separate implants is technically challenging and, with the attendant need for excruciating force on the grafting, results in excessive stress and trauma to the central wall of the bodily passage, which can lead to subsequent program complexity. Second, because the central wall of the branch of the body passage (ie in the bifurcation region) is not supported by the respective implanted membrane, this region of the body passage remains essentially unprotected from being blocked.

A particularly dangerous area of branching body passages occurs when branch damage occurs in the coronary circulation. In general, these damages can be divided into the following types:

Type Features

A Prebranch stenosis not involving the foramen of the side branches;

B Postbranch stenosis does not involve side branches;

C Stenosis around lateral branch not involving foramen;

D Stenosis involving the parent canal and side branch pores;

E stenosis involving only the small foramen of the side branches; and

F Stenosis involving parent duct and side branch foramen without association.

See Interventional Cardiology Atlas (Popma et al.), 1994, pp. 77-79, the contents of which are hereby incorporated by reference. The presence of branch trauma portends increased management complexity including acute vessel occlusion.

US Patent 4,994,071 (MacGregor), the contents of which are hereby incorporated by reference, describes a device for implanting branches into a membrane. Its specific design employs a series of generally parallel oriented loops consisting of sequential "half-birch" interconnections. The grid structure of the implanted membrane described is made of wires. The use of such wires is important in order to obtain the designed loop structure. U.S. Patents 3,993,078 (Bergentz et al.) and 5,342,387 (Summers), the contents of which are hereby incorporated by reference, also illustrate and draw branched implant membrane designs of wire structures.

Various novel branched implant membranes are described in Published Canadian Patent Application No. 2,134,997 (Penn et al.) and International Patent Application PCT/CA97/00294 (Penn et al.), the contents of which are hereby incorporated by reference .

US Patent 5,749,825 (Fischell et al.) describes an implantable membrane delivery catheter system, the contents of which are hereby incorporated by reference.

Thus, while branched implants are widely known, basic knowledge about them is significantly less than that of single-channel implants. Not surprisingly, there is a similar imbalance in knowledge regarding delivery systems for such implanted membranes. In particular, much more knowledge is available for single-tube implanted membrane delivery systems than for branched implanted membrane delivery systems.

In any implant (single-tunnel or branched) delivery, it is reasonable to accept that the implant is mounted on a catheter that is guided to the target by a guide wire previously threaded through the guide catheter. Location. Thus, when the purpose is to deliver a branching implant, it will face the guide wires for which a pair will be used - ie one for each of the two channels branching off from the primary body channel. It is therefore important that in the primary channel neither the guide wires nor the guide wires become entangled with each other in the channel as this would prevent the catheter from being guided to the target site. Additionally, the limited size of the guide catheter dictates the bulkiness of the branch implant delivery system. The net result of this is that the current method of delivering branch implants to membranes is cumbersome, cumbersome and technically complex. To date, the inventors of the present invention have not seen an answer to the conventional problem of branch implant membrane delivery.

Accordingly, it would be desirable to have a system capable of guiding a pair of guide wires in a substantially untangled state to facilitate delivery of branch implant membranes. The advantages of the miniaturization of such a system relative to conventional branch implant membrane delivery systems are also highly desirable.

Brief description of the invention

It is an object of the present invention to provide a novel branch implant membrane delivery system which overcomes or alleviates at least one of the aforementioned disadvantages of the prior art.

Thus, in one aspect, the present invention provides an intravascular liner for delivering a pair of guide wires to a branched body passage, the liner comprising a first tubular channel and a second tubular channel fixed to each other, the first tubular channel comprising The first distal end and the first proximal end, the second tubular channel includes the second distal end and the second proximal end, the first distal end is longer than the second distal end so as to define a joint, the joint is tightly By the bifurcation point of the branching body channel.

A set of branch implant membrane delivery kits for delivering branch implant membranes to branch body passages, for delivering repair implant membranes to branch body passages, the branch body passages including the first body passage, the second body passage, and the two Forks between, the kit includes:

An intravascular liner, comprising a first tubular passage including a first distal end and a first proximal end, and a second tubular passage comprising a second distal end and a second proximal end , the second distal end of the second tubular channel is secured to the first tubular channel adjacent to the first distal end to define: i) a junction close to the bifurcation point of the branching body passage, ii) the junction of an extension in the distal first tubular passage for insertion into one of the first or second body passage;

The first guide wire is used to insert the second tubular channel of the bushing;

a second guide wire for insertion into the second tubular channel of the liner; and

A catheter for passing the first guide wire and the second guide wire after delivering the first guide wire and the second guide wire to the branch channel.

In another aspect, the present invention provides a delivery method for delivering a branch implant to a target branch body passage having a proximal body passage, a first distal body passage and a second distal body passage, delivering An intravascular liner is used, the liner includes a fixed first tubular channel and a second tubular channel, the first tubular channel includes a first distal end and a first proximal end, and the second tubular channel includes a second distal end end and a second proximal end, the first distal end being longer than the second distal end so as to define a junction that abuts the bifurcation point of the branching body passage. The method comprises the steps of:

(i) directing the first guidewire through the primary proximal body passage and into the first distal body passage;

(ii) Put the first tubular channel of the intravascular liner on the first guide wire;

(iii) guiding the endovascular liner through the initial proximal body passage until the first distal end is placed into the first distal body passage with the junction adjacent to the branching body passage bifurcation point;

(iv) guiding a second guidewire through the second tubular channel and into the second distal body channel;

(v) withdrawing the endovascular liner from the body passage;

(vi) introducing a catheter with a branched implanted membrane on the first guide wire and the second guide wire;

(vii) directing the branch implant membrane to a branch body channel target area; and

(viii) expanding the branch implant membrane.

Thus, the present invention develops an endovascular liner that can be used to guide a pair of guide wires into branching body passages such that, once in place, the guide wires are virtually untwisted and tangle-free. This greatly facilitates delivery of branch implants to branch arteries.

Brief description of the drawings

The description of the preferred embodiments of the present invention will refer to the drawings herein, in which like numbers designate like parts:

Fig. 1 shows the side view of the first preferred example of the intravascular liner of the present invention;

Fig. 2 shows the side view of the second preferred example of the intravascular liner of the present invention;

Figures 3-7 show enlarged views of how a pair of guidewires are delivered using the intravascular liner of the present invention;

8-12 show perspective views of how to deliver a pair of guidewires using the intravascular liner of the present invention;

Figures 13-15 show enlarged views of how the implanted membranes deliver the branches when a pair of guidewires are guided into place; and

Figure 16 shows an enlarged view of the implantation of the branch implant membrane delivered in Figures 13-15.

Detailed description of the preferred embodiment

Referring to Figure 1, an intravascular liner 10 is shown. The endovascular liner 10 includes a first tubular channel 20 having a first distal end 22 and a first proximal end 24 . The endovascular liner 10 also includes a second tubular channel 30 having a second distal end 32 and a second proximal end 34 . The first tubular channel 20 and the second tubular channel 30 are combined and fixed along the connecting seam 40 . As shown, the first distal end 22 protrudes beyond the second distal end 32 . This difference between the two distal ends defines a junction 45 . Preferably, the first distal end 22 protrudes beyond the second distal end 32 by at least about 0.3 cm, more desirably by a limit of about 0.3 to about 3 cm. Most desirably there is a limit range of about 0.5 to about 2 cm. Also, the first proximal end 24 is significantly offset from the second proximal end 34 . As will be demonstrated below, this offset allows the endovascular liner 10 to resemble an "over the wire/monorail" delivery system. As shown, both the first distal end 22 and the second distal end 32 are chamfered or beveled.

Referring to Figure 2, an intravascular liner 100 is shown. The endovascular liner 100 includes a first tubular channel 120 having a first distal end 122 and a first proximal end 124 . The endovascular liner 100 also includes a second tubular channel 130 having a second distal end 132 and a second proximal end 134 . The first tubular channel 120 and the second tubular channel 130 are connected and fixed to each other along the connecting seam 140 . As shown, the first distal end 122 extends past the second distal end 132 . This offset between the first distal end 122 and the second distal end 132 defines a junction 145 . Preferably, the first distal end 122 protrudes beyond the second distal end 132 by at least about 0.3 cm, more desirably from about 0.3 to about 3 cm, and most desirably from about 0.5 to about 2 cm. Additionally, unlike the "over the wire/monorail" delivery system shown in FIG. 1 , the first proximal end 124 is actually substantially aligned with the second proximal end 134 . This reciprocal placement of the first proximal end 124 and the second proximal end 134 makes the endovascular liner 100 resemble a "dual pass wire" delivery system. As shown, both the first distal end 122 and the second distal end 132 are chamfered or beveled.

The material used to construct the endovascular liner 10 is not particularly limited, although it is: (i) substantially intact so as to be able to be guided through tortuous body passages, and (ii) suitable for the material through which the endovascular liner 10 will be guided. Subject is non-toxic. Non-limiting examples of suitable materials include growth promoting polyester, flexible metal tubing, and the like.

Referring to Figures 3-7, the use of the intravascular liner 10 to deliver a pair of guidewires will be discussed.

As shown, the branched body channel 50 includes a proximal channel 52 and a pair of remote channels 54,56. The junction of the remote channels 54, 56 defines a branching point 58. Stenosis within branch body passage 50 is not shown for clarity.

Referring to FIG. 3 , the first guide wire 60 is guided in the direction of arrow A through the proximal channel 52 into the remote channel 54 .

Referring to FIG. 4 , the first tubular channel 20 is pulled over the guide wire 60 in the direction of arrow A until it enters the remote channel 54 , and the junction 40 of the endovascular liner 10 abuts the bifurcation point 58 of the branching body channel 50 . In the example shown, the endovascular liner 10 is also provided with a radiopaque marker (eg, made of gold or similar material) at or near the junction 40 . The location can be monitored using conventional video radiography techniques. Once the endovascular liner 10 is positioned in this manner, the second distal end 32 of the second tubular channel 30 opens into the distal end channel 56 .

Referring to FIG. 5 , once the endovascular liner 10 is in place (ie, as shown in FIG. 4 ), the second guide wire 62 is also passed in the direction of arrow A through the second tubular channel 30 into the distal channel 56 .

Referring to FIG. 6 , once the guide wires 60 , 62 are properly positioned, the endovascular liner 10 is withdrawn from the branch body channel 50 in the direction of arrow B. Referring now to FIG. It will be apparent to those skilled in the art that care must be taken to avoid twisting of the endovascular liner 10 as this would cause this twisting to be transmitted to the guide wires 60,62.

Referring to Fig. 7, once the endovascular liner 10 is fully withdrawn from the branched body passage 50, the guide wires 60 and 62 leave their distal ends in the distal passages 54, 56, respectively.

Referring to Figures 8-12, there are shown perspective views of a pair of guidewires delivered using the intravascular liner 10 as discussed above in Figures 3-7, respectively.

As shown, endovascular liner 10 is guided to subject 70 through a suitable incision near the groin of subject 70 . In general, the correspondence between the perspective view in Figure 8-12 and the enlarged view shown in Figure 3-7 is:

Figure 8 corresponds to Figure 3;

Figure 9 and Figure 10 correspond to Figure 4;

Figure 11 corresponds to Figure 5; and

FIG. 12 corresponds to FIGS. 6 and 7 .

As discussed above, the endovascular liner 10 can be viewed as a "over the wire/monorail" delivery system. This means that once the bushing is in the correct position, one tubular channel (30) remains over the guide wire (62) so that its proximal end (34) emerges from the subject, while the other tubular channel ( The proximal end (24) of 20) does not emanate from the subject. In other words, the portion of the other tubular channel (20) between the branching body channel (50) and the incision (72) of the subject (70) does not completely entrap the other guide wire (60).

As discussed above, the endovascular liner 100 can be viewed as a "dual pass-through wire" delivery system. This means that once the bushing is in the correct position, both tubular channels (120, 130) are left on their respective guide wires (60, 62) such that each tubular channel (120, 130) The proximal end (24) of the tube is emitted by the subject. In other words, a guide wire ( 60 , 62 ) is virtually entirely covered by the endovascular liner 100 .

Referring to Fig. 7, when the intravascular liner is removed, the guide wires 60 and 62 remain as shown at the point where they emanate from the subject, and are virtually untwisted. Referring to FIG. 13 , at this point, a catheter 80 is used to deliver the branched implant membrane to the branched body channel 50 . Specifically, catheter 80 includes a balloon 82 with a pair of tubes 84, 86 extending from one end thereof. A branched implant membrane 88 is mounted on the balloon 82 . Tubes 84 and 86 are of conventional annular design so that they can each be routed over their guide wires and receive the fluid that fills balloon 82 to expand it. Thus, the catheter 80 is guided over the guide wires 60 and 62 until the branch implant reaches the correct position - see FIG. 14 . At this point, pressurized fluid (such as saline) is introduced into the balloon 82 through the tubes 84, 86, causing the balloon 82 and implant membrane 88 to expand—see FIG. 15 . The balloon 82 is then routinely depressurized and withdrawn from the branch body channel 50 leaving the implant membrane 88 in place - see FIG. 16 . Although balloons 82 are shown as adjacent pairs of individual balloons, those skilled in the art will understand that branched balloons could also be used in place of a pair of individual balloons.

While the invention has been described with reference to examples, these descriptions are not meant to be limiting. Obviously, various modifications of the described examples, as well as other inventive examples, from such descriptions will be apparent to those skilled in the art.

Claims (31)

1. be used to transmit a kind of endovascular sleeve of a pair of guide wire to branch's body passage, this branch's body passage comprises the 1st body passage, the 2nd body passage, and the forked section between the two, this lining comprises the 1st tubular conduit and the 2nd tubular conduit, the 1st tubular conduit comprises the 1st distal end portion and the 1st proximal end, the 2nd tubular conduit comprises the 2nd distal end portion and the 2nd proximal end, it is characterized in that, the 2nd distal end portion of the 2nd tubular conduit is fixed to the 1st tubular conduit and contiguous the 1st distal end portion, to determine: an i) contact near the bifurcation in branch's body passage, the ii) extension in the 1st tubular conduit, in the distally of this contact, be used to insert one of the 1st body passage and the 2nd body passage.

2. by the described endovascular sleeve of claim 1, comprise that also one puts the radio opaque markers of setting in this lining blood vessels.

3. by the described endovascular sleeve of claim 2, this radio opaque markers is placed the contact place by society.

4. by the described endovascular sleeve of claim 1, wherein the 1st tubular conduit has round cross section.

5. by the described endovascular sleeve of claim 1, wherein the 2nd passage has round cross section.

6. by the described endovascular sleeve of claim 1, wherein the 1st passage and the 2nd passage all have round cross section.

7. by any described endovascular sleeve among the claim 1-6, wherein the length of this extension is 0.3cm at least.

8. by any described endovascular sleeve among the claim 1-6, wherein the length of this extension is 0.3～3cm.

9. by any described endovascular sleeve among the claim 1-6, wherein the length of this extension is 0.5～2cm.

10. by any described endovascular sleeve among the claim 1-6, wherein the 1st distal end portion is chamfering.

11. by any described endovascular sleeve among the claim 1-6, wherein the 2nd distal end portion is chamfering.

12. by any described endovascular sleeve among the claim 1-6, wherein the 1st distal end portion and the 2nd distal end portion all are chamferings.

13. a cover bifurcated stent transmits apparatus, is used for transmitting repairing implanting film to branch's body passage, this branch's body passage comprises the 1st body passage, the 2nd body passage and the forked section between the two, and described apparatus comprises:

One endovascular sleeve, comprise the 1st tubular conduit and the 2nd tubular conduit, the 1st tubular conduit comprises the 1st distal end portion and the 1st proximal end, the 2nd tubular conduit comprises the 2nd distal end portion and the 2nd proximal end, the 2nd distal end portion that it is characterized in that the 2nd tubular conduit is fixed to the 1st tubular conduit and contiguous the 1st distal end portion, to determine: an i) contact near the bifurcation of branch's body passage

Ii) the extension in the 1st tubular conduit in the distally of this contact, is used to insert one of the 1st body passage and the 2nd body passage;

The 1st guide wire is used to insert the 2nd tubular conduit of this lining;

The 2nd guide wire is used to insert the 2nd tubular conduit of this lining; And a conduit, be used for to this branched bottom, transmitting the 1st guide wire and the 2nd guide wire transmitting the 1st guide wire and the 2nd guide wire.

14. by the described apparatus of claim 13, this endovascular sleeve comprises that also one is arranged at the radio opaque markers that this lining blood vessels puts.

15. by the described apparatus of claim 14, wherein this radio opaque markers is set on the contact.

16. by the described apparatus of claim 13, wherein the 1st tubular conduit has round cross section.

17. by the described apparatus of claim 13, wherein the 2nd tubular conduit has round cross section.

18. by the described apparatus of claim 13, wherein the 1st tubular conduit and the 2nd tubular conduit all have round cross section.

19. by any described apparatus among the claim 13-18, wherein this extension length is at least 0.3cm.

20. by any described apparatus among the claim 13-18, wherein this extension length is 0.3～3cm.

21. by any described apparatus among the claim 13-18, wherein this extension length is 0.5～2cm.

22. by any described apparatus among the claim 13-18, wherein the 1st distal end portion is chamfering.

23. by any described apparatus among the claim 13-18, wherein the 2nd distal end portion is chamfering.

24. by any described apparatus among the claim 13-18, wherein the 1st distal end portion and the 2nd distal end portion all are chamferings.

25. by any described apparatus among the claim 13-18, wherein conduit comprises distensible parts at least.

26. by the described apparatus of claim 25, wherein distensible component configuration is near the distal end portion of conduit.

27. by the described apparatus of claim 25, wherein conduit comprises two distensible parts.

28. by the described apparatus of claim 25, wherein conduit comprises that one is the expandable member of Y-type.

29. by any described apparatus in the claim 25, wherein distensible parts are balloons.

30., comprise that also one is configured in the expansible prosthesis on the expandable member by the described apparatus of claim 25.

31. by the described apparatus of claim 30, wherein this distensible prosthesis is assembled on these distensible parts.

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