Source: https://patents.google.com/patent/US10363392B2/en
Timestamp: 2019-10-17 03:50:53
Document Index: 513419057

Matched Legal Cases: ['§ 119', 'arts 106', 'Application No. 61', 'Application No. 18167829', 'Application No. 11', 'Application No. 07', 'Application No. 10', 'Application No. 09743698']

US10363392B2 - Deflectable guide - Google Patents
US10363392B2
US10363392B2 US15/479,718 US201715479718A US10363392B2 US 10363392 B2 US10363392 B2 US 10363392B2 US 201715479718 A US201715479718 A US 201715479718A US 10363392 B2 US10363392 B2 US 10363392B2
US15/479,718
US20170361065A1 (en
2011-12-08 Priority to US13/315,154 priority patent/US20120101442A1/en
2017-04-05 Priority to US15/479,718 priority patent/US10363392B2/en
2017-04-05 Application filed by Ancora Heart Inc filed Critical Ancora Heart Inc
2017-04-06 Assigned to ANCORA HEART, INC. reassignment ANCORA HEART, INC. CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: GUIDED DELIVERY SYSTEMS INC.
2017-04-06 Assigned to GUIDED DELIVERY SYSTEMS INC. reassignment GUIDED DELIVERY SYSTEMS INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LEGASPI, MARLONE, NGUYEN, HUU, SERINA, EUGENE
2017-12-21 Publication of US20170361065A1 publication Critical patent/US20170361065A1/en
2019-07-30 Publication of US10363392B2 publication Critical patent/US10363392B2/en
239000000463 materials Substances 0 abstract description 58
Described herein are devices and methods for guide catheters having one or more regions of increased flexibility. A flexibility region comprises one tubular segment of the guide catheter with a non-linear seam between two non-concentric layers of material having different durometers. A non-linear seam, such as a zig-zag or sinusoidal configuration, permits controlled compression of lower durometer material between portions of higher durometer material.
The present application is a continuation of U.S. application Ser. No. 13/315,154, filed on Dec. 8, 2011, which is a divisional of U.S. application Ser. No. 12/437,495, filed on May 7, 2009, now issued as U.S. Pat. No. 8,096,985, which claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application Ser. No. 61/051,292, filed on May 7, 2008, and to U.S. Provisional Application Ser. No. 61/160,670 filed on Mar. 16, 2009, which are hereby incorporated by reference in their entirety.
Guide catheters are used in a variety of therapeutic and diagnostic medical procedures to facilitate insertion of instruments and implantable components. Guide catheters often comprise a rigid material or support structure to provide the torqueability and pushability characteristics that facilitate passage of the guide catheter to a particular site. With the stiffer material or support structure, the responsiveness of the distal portion of the guide catheter to manipulation of the proximal portion of the guide catheter typically improves. A flexible material, however, permits the guide catheter to navigate around tight bends and other hard-to-reach places. Although some guide catheters may be genetically configured for use with a variety of procedures, some guide catheters have a particular length, stiffness and distal tip shape adapted for access to a specific tissue or organ.
In another embodiment, a catheter is provided, comprising a deformation zone comprising a proximal end, a distal end, a longitudinal length therebetween, a first polymeric layer comprising a proximal edge, a distal edge, a first lateral edge and a second lateral edge, and a second polymeric layer comprising a proximal edge, a distal edge, a first lateral edge and a second lateral edge, wherein the first polymeric material has a lower durometer than the second polymeric material, and wherein the first lateral edge of the first polymeric layer is joined to at least a portion of the second lateral edge of the second polymeric layer, and wherein the second lateral-edge of the first polymeric layer is joined to at least a portion of the first lateral edge of the second polymeric layer.
FIG. 3A illustrates one embodiment of a deflectable guide catheter; FIG. 3B is a detailed view of the catheter body of the deflectable guide catheter in FIG. 3A; FIG. 3C is a detailed view of the distal end of the deflectable guide catheter in FIGS. 3A and 3B; FIGS. 3D and 3E are various cross sectional views of the catheter body of FIG. 3B;
FIG. 8A illustrates one embodiment of a deformable zone of a deflectable guide catheter; FIGS. 8B and 8C represent various cross sections of the deformable zone depicted in FIG. 8A;
FIG. 9A illustrates another embodiment of a deformable zone of a deflectable guide catheter; FIGS. 9B and 9C represent various cross sections of the deformable zone depicted in FIG. 9A;
FIG. 10A illustrates another embodiment of a deformable zone of a deflectable guide catheter; FIG. 10B represents a cross section of the deformable zone depicted in FIG. 10A;
FIG. 11A is a schematic representation of one embodiment of a steering mechanism; FIG. 11B is a schematic representation of another embodiment of a steering mechanism;
FIG. 14A is a superior elevational view of a variation of a steerable guide catheter; FIG. 14B is a detailed superior elevational view of the distal end of the guide catheter; FIG. 14C is a side elevational view of the distal end of the guide catheter; FIG. 14D is a detailed superior elevational view of the proximal end of the guide catheter; and FIG. 14E is a longitudinal cross sectional view of the steering mechanism of the guide catheter.
FIG. 15A is a perspective view of a variation of a hemostatic seal; FIG. 15B is a posterior elevational view of the seal; and FIG. 15C is a cross-sectional view of the seal.
The case of inserting a catheter to a body location may be influenced by a number of catheter characteristics. While a catheter made from stiffer materials may improve its user responsiveness relating torqueability and pushability over longer insertion distances, stiffer catheter materials may affect the catheter's maneuverability through tight anatomical bends. In some cases, catheter maneuverability may be improved by using a steering mechanism to position the catheter tip in the desired orientation or direction. FIG. 1 illustrates one example of a steerable catheter segment, comprising a tubular catheter body 4 with one or more conduits 6 and a pull lumen 8 containing a pull member 10. Typically, pull member 10 is attached distally to catheter body 4 such that, when pulled proximally, pull member 10 will cause catheter body 4 to bend, as shown in FIG. 2A. While a steering mechanism 12 may improve the bending range of stiffer catheter materials, such materials may cause creases 14 or other discontinuities in catheter body 4 when bent, as illustrated in FIG. 2A. Further, such creases 14 may impair the ability to pass instruments 16 or components down conduit 6, as shown in the cross-sectional view of FIG. 2B.
Catheter body 4 and/or conduits 6 may be reinforced (e.g., with tubular or arcuate braiding, circular loops, helical structures, or longitudinal supports). The reinforcing structure or structures may comprise a metallic material or a non-metallic material. Metallic materials that may be used include but are not limited to stainless steel such as 316L, nitinol and cobalt-chromium.
Referring to FIG. 3E, in this specific embodiment, deformation zone 18 comprises an outer layer 42 formed by first layer segment 20 and second layer segment 22. Conduit 6, pull lumen 8, pull member 10 and reinforcement structure 40 are arranged in deformation zone 18 similar to proximal section 44, except that a second reinforcement structure 34 is provided. In this embodiment, second reinforcement structure 54 comprises a second tabular stainless steel braid surrounding conduit 6 and pull lumen 8. In some embodiments, second reinforcement structure 54 may originate proximally in pre-deformation section 48 of distal section 46. The portion 56 of tubular body 36 between reinforcement structures 40 and 54 may comprise a similar material as segments 20 or 22, or a different material.
As mentioned previously, segments 20 and 22 may be joined at their lateral edges to form two longitudinal interfaces 24. Is this specific embodiment, segment 20 comprises PEBAX 35D while segment 22 comprises PEBAX 72D. Because segments 20 and 22 in this specific embodiment have generally semi-circular configurations, longitudinal interfaces 24 have generally 180 degree opposite locations with respect to conduit 6. In other embodiments, however, deformation zone 18, interfaces 24 may be angularly closer together, or may comprise three or more interfaces 24.
Referring back to FIG. 3C, in some embodiments, distal section 46 further comprises a post-deformation section 50 distal to deformation zone 18. Post-deformation section 50 may be straight, angled or curved, or a combination thereof. Post-deformation section 50 may have a longitudinal length of about 0.25 inches to about 5 inches or more, sometimes about 0.5 inches to about 2 inches, and occasionally about 0.75 inches to about 1.25 inches. Post-deformation section 50 may comprise one or more layers. In some embodiments, post-deformation section 50 comprises the same material as one of the segments from deformation zone 18, but in other embodiments, post-deformation section 50 may comprise a material having a higher, lower or intermediate durometer. For example, in one embodiment of the invention, segments 20 and 22 of deformation zone 18 comprise PEBAX 35D and 72D, respectively, while post-deformation section 50 comprises PEBAX 55D. Post-deformation section 50 may or may not include one or more reinforcement structures. In some embodiments, the reinforcement structure may be contiguous with reinforcement structures 40 and/or 54, and in some embodiments may include a reinforcement structure different from reinforcement structure 40 and/or 54.
In some embodiments, one or more conduits from the proximal portions of catheter body 4 may pass through post-deformation section 50 or terminate within it. In embodiments of the invention with a single deformation zone and/or steering mechanism, however, pull lumen 8 and/or pull member 10 may terminate within post-deformation section 50. To facilitate the exertion of force in distal section 46 of catheter body 4, pull member 10 may comprise a distal pull structure 58. Pull member 10 may be coupled to distal pull structure 58 or be contiguous with distal pull structure 58. In the embodiment illustrated in FIG. 3C, distal pull structure 58 may comprise a ring-like structure embedded in post-deformation section 50. In alternate embodiments, distal pull structure 58 may comprise a helical winding of pull member 10 or some other wire-based configuration. Pull member 10 may comprise any of a variety of materials and structures sufficient to transmit longitudinal forces along a length of catheter body 4. Pull member 10 and distal pull structure 55 may be metallic, non-metallic or a combination thereof, including but not limited to stainless steel, nitinol, nylon or other polymeric material. In some embodiments, pull member 10 may be coated, for example, to facilitate sliding in pull lumen 8. Such coatings may include PTFE.
As depicted in FIG. 3C, catheter body 4 may optionally comprise a distal tip 60 with a different structure or configuration relative to post-deformation section 50. In embodiments, distal tip 60 is configured as an atraumatic tip and may comprise a material and/or structure different from tubular body 36, deformation zone 18 or post-deformation section 50. In some embodiments, distal tip 60 comprises a material with a durometer equal to or lower than a material found in either deformation zone 18 or post-deformation section 50. In one specific example, distal tip 60 comprises PEBAX 35D, while post-deformation section 50 comprises PEBAX 55D, segment 20 comprises PEBAX 35D, segment 22 comprises PEBAX 72D and tubular body 36 comprises PEBAX 72D. Distal tip 60 may have a longitudinal length of about 1 mm to about 20 mm or more, sometimes about 2 mm to about 10 mm, and occasionally about 5 mm. The inner and outer diameters of distil tip 60 may be the same or different from other portions of catheter body 4.
As depicted in FIGS. 7A to 7C, interface 24 need not comprise the same repeating pattern along its entire length. For example, in the embodiment depicted in FIG. 7A, interface 24 comprises a linear portion 78 followed by a zig-zag portion 80 and another linear portion 82. In another embodiment depicted in FIG. 7B, interface comprises the same pattern but with sections of low and high amplitude 84 and 86, respectively. In still another embodiment shown in FIG. 7C, interface 24 comprises a pattern of similar amplitude but contains portions with relatively shorter and longer repeating lengths 88 and 90, respectively. These features may be mixed and matched to achieve the desired structural features in deformation zone 18.
Any of a variety of control mechanisms may be used to manipulate one or more pull members 10. In FIG. 3A, for example, a rotatable knob 100 may be provided on steering catheter 2. Referring to FIG. 11A, the proximal end 102 of pull member 10 may be attached to a rotating knob 102, or alternatingly to a pivoting lever 104, as illustrated schematically in FIG. 11B. In other embodiments, pull member 10 may be manipulated by a pull ring or a slider. Steering mechanism 12 may further comprise a bias member (not shown), such as a spring or elastic member, to bias distal section 46 to a particular position. Steering mechanism may also comprise a releasable locking mechanism to maintain pull member 10 in a desired position.
Referring back to FIG. 3A, the proximal end of guide catheter 2 may have one or more parts 106, 108 and 110. These ports may communicate with conduit 6 or other conduits of multi-conduit embodiments of the invention. In some embodiments, one or more ports may be provided to obtain blood samples, for injection of intravenous fluids, radiographic or therapeutic agents, or for the attachment of a pressure transducer. One or more ports 106, 108 and 110 may be configured with a hemostasis valve to reduce fluid or blood leakage, and/or a lock for resisting displacement of any components inserted into that port. In one embodiment, the lock is a releasable lock that can be released and re-engaged as needed. In some embodiments, the components used with a port may include one or more indicia along its length that may be used to identify the degree of insertion into guide catheter 2.
In another variation, shown in FIG. 14A, the steerable catheter 4000 comprises a deformation region 4002 with a segment of the catheter body 4004 having a first layer segment 4006 and a second layer segment 4008 with a generally linear longitudinal interface 4010 therebetween. The first layer segment 4006 comprises a lower durometer material and the second layer segment 4008 comprises a higher durometer material. The catheter body 4004 may further comprise a proximal shaft 4012 and a distal shaft 4014 with respect to the deformation region 4002. The proximal shaft 4012 may comprise a tabular configuration with at least one inner lumen (not shown) that may be optionally lined with a coating. The proximal shaft 4012 may have a generally linear configuration, but in other variations, proximal shaft 4012 may have a non-linear configuration, including angled and curved sections or combinations thereof, such as the arch curve region 4018. The distal shaft 4014 may also have a linear or curved configuration, such as the valve curve region 4020 depicted in FIGS. 14B and 14C. Additional variations and methods of use for these and other deflectable guide catheters are described in U.S. Provisional Application No. 61/160,670 entitled “VISUALIZATION METHODS AND RELATED DEVICES AND KITS”, filed Mar. 16, 2009, which is hereby incorporated by reference in its entirety. In some variations, the proximal shaft 4012 may comprise one or more reinforcement structures 4022, such as tubular or arcuate braiding or interweaving, circular loops, helical structures, or longitudinal supports). The reinforcement structure may comprise one or more metallic or non-metallic materials as described previously. In one example, the proximal shaft 4012 may comprise an outer layer of PEBAX 72 D, and the reinforcement structure 4022 may comprise a tubular stainless steel wire braid, which in turn may have an inner coating of PTFE. In the example of FIG. 14A, the distal shaft 4014 comprises a material having a durometer between the durometer of the first and second segments 4006 and 4008, but in other examples, the durometer may be generally equal to, less than or greater than the first and second segments 4006 and 4008, respectively. The distal shaft 4014 may also comprise an atraumatic tip 4024, which may comprise a material having lower durometer than the rest of the distal shaft 4014, or may be tapered or otherwise shaped to be more flexible or deformable. The distal shaft 4014 may comprise a linear or non-linear configuration, and may be oriented in the same or a different plane with respect to the deformation region 4002 and/or proximal shaft 4012, as shown in FIG. 14D.
1. A method for accessing a cardiac region of a patient, comprising:
advancing a guide catheter from a peripheral vascular site in a retrograde direction through an aorta into a left ventricle, the guide catheter comprising a tubular body comprising a proximal section and a distal section, the distal section comprising a deformation zone, a curved pre-deformation section proximal to the deformation zone and a curved post-deformation section distal to the deformation zone, wherein the deformation zone has a proximal end, a distal end, a longitudinal length and a longitudinal axis therebetween, a first constricting portion, a second constricting portion and a compressible portion in alternating configuration with the first and second constricting portions along the longitudinal axis, wherein the first and second constricting portions have a higher hardness and the compressible portion has a lower hardness and wherein the guide catheter further comprises a pull member coupled to a pull structure that is located in the post-deformation section;
steering the guide catheter into a subvalvular region adjacent mitral valve leaflets by pulling the pull member to bend the catheter such that the first and second constricting portions compress the compressible portion therebetween.
2. The method of claim 1, wherein the proximal section has a pre-configured curve.
3. The method of claim 1, wherein the pull structure comprises a ring-like structure.
4. The method of claim 3, wherein a proximal end of the pull member is coupled to a rotating knob.
5. The method of claim 3, wherein a proximal end of the pull member is coupled to a lever.
6. The method of claim 3, wherein a proximal end of the pull member is coupled to a bias member.
7. The method of claim 1, further comprising passing an instrument down a conduit of the guide catheter.
8. The method of claim 7, wherein the instrument is a multi-window tunnel catheter.
9. The method of claim 7, wherein the instrument is guidewire.
10. The method of claim 1, wherein advancing the guide catheter comprises passing the guide catheter through an aortic valve to the left ventricle, and steering the guide catheter into the subvalvular region from the aortic valve comprises bending the deformation zone to prevent looping of the guide catheter below chordae tendinae of the left ventricle.
11. The method of claim 1, wherein the deformation zone is at an angle with respect to the pre-deformation section.
12. The method of claim 11, wherein the angle is from about 0 degrees to about 345 degrees.
13. The method of claim 1, wherein the compressible portion is located between the first constricting portion and the second constricting portion.
14. The method of claim 1, wherein the guide catheter further comprises a reinforcement structure surrounding the tubular body.
15. The method of claim 14, wherein the reinforcement structure comprises a tubular braid.
16. The method of claim 1, wherein the compressible portion of the deformation zone is a first compressible portion and wherein the deformation zone further comprises a second compressible portion and a third constricting portion, wherein the second compressible portion is in alternating configuration with the second and third constricting portion along the longitudinal axis of the deformation zone, wherein the second compressible portion has a lower hardness and the third constricting portion has a higher hardness, and wherein bending the catheter causes the second and third constricting portions to compress the second compressible portion.
17. A method for accessing a cardiac region of a patient, comprising:
passing the guide catheter through a cardiac valve orifice; and
steering the guide catheter into a subvalvular region adjacent the cardiac valve orifice by pulling the pull member to bend the catheter such that the first and second constricting portions compress the compressible portion therebetween.
18. The method of claim 17, wherein the cardiac valve orifice is an aortic valve orifice.
19. The method of claim 17, wherein the cardiac valve orifice is a mitral valve orifice.
20. The method of claim 17, further comprising passing an instrument down a conduit of the guide catheter.
21. The method of claim 17, wherein the instrument is a multi-window tunnel catheter.
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Free format text: CHANGE OF NAME;ASSIGNOR:GUIDED DELIVERY SYSTEMS INC.;REEL/FRAME:042180/0718