Source: https://patents.google.com/patent/US7976539B2/en
Timestamp: 2019-04-25 14:21:40+00:00

Document:
2005-11-28 Assigned to HANSEN MEDICAL, INC. reassignment HANSEN MEDICAL, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HLAVKA, EDWIN J., MOLL, FREDERIC H., WALLACE, DANIEL T., YOUNGE, ROBERT G.
The present application claims the benefit under 35 U.S.C. §119 to U.S. provisional patent application Ser. Nos. 60/677,580, filed May 3, 2005, and 60/678,097, filed May 4, 2005, 60/600,869, filed Aug. 12, 2004, 60/644,505, filed Jan. 13, 2005 and 60/589,513, filed Jul. 19, 2004. The foregoing applications, along with U.S. patent application Ser. No. 11/176,957, filed Jul. 6, 2005, and Ser. No. 11/073,363, filed Mar. 4, 2005, are hereby incorporated by reference into the present application in their entirety.
FIGS. 2A-2B show a denatured collagenous tissue mass.
FIGS. 5A-5C shows a denatured collagenous tissue mass after being exposed to Genepin.
FIGS. 8-9 show variations of a method for utilizing RF to denature tissue along with Genepin fixation treatment.
Referring to FIG. 7, one embodiment of a method for utilizing an RF device to locally denature collagenous tissue is depicted. A robotic catheter may be utilized to precisely access a targeted tissue structure, contact the targeted tissue structure with an RF electrode which may be coupled to the distal end of the robotic catheter, apply RF power to at least partially denature the subject tissue, and repeat as necessary to achieve a desired level of tissue shrinkage. Referring to FIGS. 8 and 9, embodiments utilizing genepin fixation treatment along with localized RF-induced denaturation to modify tissue geometry and recover or retain the mechanical properties of the tissue are depicted. FIG. 8 depicts an embodiment wherein a separate device is utilized to apply the denaturation treatment and genepin treatment, while FIG. 9 depicts an embodiment wherein a hybrid distal tip of the subject system may be utilized to apply both treatments without serial treatment using separate distal instrument tips for RF versus chemical fixation. Referring to FIG. 10A, a system comprising an operator control station (2), an instrument driver (16), a computer or processor (6), a display monitor (4), an elongate instrument (18) coupled to an electrode (378), and an RF energy control unit (379) is depicted. Such a system may be utilized for the embodiment depicted, for example, in FIG. 7. In alternative embodiments, other modalities may be utilized, such as ultrasound or microwave radiation, or heated fluids such as hot saline, to produce localized heating at the distal end of the elongate instrument (18) for denaturation of collagenated tissue. Referring to FIG. 10B, a similar system is depicted comprising an instrument driver (16) interfaced to an instrument set (28) comprising coaxially-interfaced sheath (30) and guide (18) instruments. The guide instrument (18) is coaxially interfaced, through its inner lumen, with an elongate probe (380) which may comprise a heating and/or injecting tool at its distal tip (381). In an embodiment comprising an injecting tip, a chemical injection system (382) may be proximally coupled to the instrument set (28) and configured to controllably deliver fluid, such as a genepin formulation, through the injecting tip distally.
Referring to FIG. 11A-H, various hybrid distal tip structures for an elongate instrument configured to both inject a chemical solution, such as a genepin solution or solution of another fixative, and also apply RF energy to induce localized denaturation are depicted. FIG. 11A depicts a needle-less injection port (384) positioned through the center of a monopolar RF electrode (383). FIG. 11B depicts a series of needle injection ports (385) located upon an RF electrode (383) for a voljimic injection into a broader volume that would be practicable with a single needle. FIG. 11C depicts an extensible/retractable needle (386) injection port through the center of an RF electrode (383). FIG. 11D depicts bipolar electrode configuration wherein each of two distal elements (387) comprises both an electrode and an injection tip. FIG. 11E depicts a single injection needle through the center of an RF electrode (383), the needle (388) comprising multiple fluid pathways (389) along its length to facilitate a distributed injection through a depth of targeted tissue. The needle (388) may be extensible/retractable, as with each of the distal tip needle structures depicted herein. FIG. 11F depicts an embodiment wherein an injection needle (391) is oriented through the center of a helical structure (390), and wherein any of the distal elements may be an RF electrode—in other words, the injection needle (391) or helical structure (390) may be a monopolar electrode, or each may be an electrode in a bipolar configuration. FIG. 11G depicts an embodiment wherein a bullet-shaped electrode (392) is positioned through at least a portion of a helical injection needle (393). FIG. 11H depicts an embodiment similar to that of FIG. 11G with the exception that a distal ring (394) comprises the electrode as opposed to the bullet-shaped electrode of FIG. 11G. The helical injection needles of the embodiments depicted in FIGS. 11G and 11H may have side ports (not shown) as depicted in the embodiment of FIG. 11E, and may comprise an electrode form a bipolar electrode configuration in association with the bullet-shaped electrode (392) or ring electrode (394).
Referring to FIG. 13D, a mitral valve (603) is depicted with good coaptation when closed. A well-coated tricuspid valve (626) is also depicted. FIG. 13E depicts a similarly-sized mitral valve (603) with a significant leaflet coaptation problem when closed, primarily due to deformation of the posterior aspect (622) of the mitral annulus, as opposed to significant deformation of the anterior aspect (611) of the mitral annulus. Such posterior mitral annulus deformation conventionally may be treated with installation of an annulus reshaping prosthesis, such as that depicted in FIG. 13F. Conventional prostheses for this purpose take many forms, including configurations such as that depicted in FIG. 13F, wherein the prosthesis only substantially supports the posterior aspect (622) of the mitral annulus, and configurations such as that depicted in FIG. 13G, wherein the prosthesis (621) supports substantially all of the mitral annulus. Referring to FIG. 13G, the depicted conventional prosthesis (621), such as those known as a “Carpintier ring”, may be installed with a series of sutures (624) configured to gather and pull the posterior annulus (622) tissue anteriorly when the prosthesis (621) has been fastened into place. One of the challenges associated with such an installation is the invasiveness of the procedure. To address this challenge, the inventive instrument may be utilized to intravascularly approach the mitral annulus and treat the tissue to modify its geometry with minimal invasiveness relative to conventional open or port-based procedures.
introducing a biocompatible fixative into the tissue mass after heating the tissue mass, to retain shrinkage or tightening of the tissue mass and to retain the modified shape or position of the valve.
2. The method of claim 1, wherein the tissue mass is heated using radio frequency energy.
3. The method of claim 1, wherein the fixative is introduced into the tissue mass by injection.
4. The method of claim 1, wherein the tissue mass is heated using radio frequency energy delivered using an electrode carried on a flexible catheter, and wherein the fixative is inserted into the tissue mass by injection with a needle carried by the flexible catheter.
5. The method of claim 4, wherein the needle comprises the electrode.
6. The method of claim 4, wherein the flexible catheter is robotically controlled.
7. The method of claim 6, wherein the catheter is actuated by an instrument driver in response to signals generated by manipulation of a controller.
8. The method of claim 6, wherein the needle is controllably retractable and advanceable out of a port of the flexible catheter.
9. The method of claim 8, the flexible catheter comprising an imaging device having a field of view, the imaging device oriented such that at least a portion of the needle, when advanced out of the catheter port, is captured within the field of view.
10. The method of claim 9, the imaging device comprising an ultrasound transducer.
11. The method of claim 9, the imaging device comprising a CCD or optical camera.
12. The method of claim 1, wherein the fixative comprises genepin.
13. The method of claim 1, wherein endoluminally advancing an elongate flexible instrument comprises intravascularly advancing an elongate flexible instrument.
14. The method of claim 1, wherein the tissue mass is a biological valve annulus.
15. The method of claim 14, wherein modifying the shape or position of a valve comprises modifying valve coaptation.
16. The method of claim 1, wherein modifying the shape or position of a valve comprises modifying the shape or position of a valve annulus, valve leaflet or chordae tendineae.
"Adding Structure to the Unstructured-Computer Business Review,", http://www.cbr-online.com, World Wide Web, May 25, 2005, pp. 1-6.
"EIQ Server", http://www.whamtech.com/eiq-server.htm>, World Wide Web, May 25, 2005, pp. 1-3.
"EIQ Server", http://www.whamtech.com/eiq—server.htm>, World Wide Web, May 25, 2005, pp. 1-3.
"Innovative Applications;", http://www2002.org/spector.pdg, World Wide Web, pp. 1-5.
"The Unstructured Information Management Architecture Project", http://www.research.ibm.com/UIMA/>, World Wide Web, May 25, 2005, pp. 1-2.
Aaron Zornes, "EA Community Articles", http://www.eacommunity.com/articles/openarticle.asp?ID=1834>, World Wide Web, May 25, 2005, pp. 1-3.
Alfred Z. Spector, "Architecting Knowledge Middleware;" http://itlab.uta.edu/idm01/FinalReports/Innovation.pdf, World Wide Web, 2002. pp, 1-40.
Barbara Darrow, "IBM Looks to ‘Viper’ Database to Combat Oracle, Microsoft", http://www.bizintellignecepipeline.com/shared/article/printable.ArticleSrc.Jhtml, World Wide Web, May 25, 2005, pp. 1-5.
Barbara Darrow, "IBM Looks to 'Viper' Database to Combat Oracle, Microsoft", http://www.bizintellignecepipeline.com/shared/article/printable.ArticleSrc.Jhtml, World Wide Web, May 25, 2005, pp. 1-5.
Beth Gold-Bernstein, "EbizQ Integration Conference", http://www.ebizq.net/topics/portals/features/4371.html?page=2&pp=I >, World Wide Web, May 10, 2005, pp. 1-5.
D. Ferrucci, "Building An Example Application With The Unstructured Information Management Architecture", http://www.findarticles.com/p/articles/mi-mlSJ/is-3-43/ai-n7576557/print, World Wide Web, Mar. 16, 2004, pp. 1-22.
D. Ferrucci, "Building An Example Application With The Unstructured Information Management Architecture", http://www.findarticles.com/p/articles/mi—mlSJ/is—3—43/ai—n7576557/print, World Wide Web, Mar. 16, 2004, pp. 1-22.
European Patent Application No. 00944803.6 filed Jun. 23, 2000 in the name of Saadat et al., Communication under Rule 71(3) mailed Nov. 20, 2009.
European Patent Application No. 00944803.6 filed Jun. 23, 2000 in the name of Saadat et al., office action mailed Aug. 8, 2008.
European Patent Application No. 00944803.6 filed Jun. 23, 2000 in the name of Saadat et al., office action mailed Mar. 16, 2009.
European Patent Application No. 00944803.6 filed Jun. 23, 2000 in the name of Saadat et al., Search Report mailed Jun. 3, 2005.
European Patent Application No. 02749755.1 filed Jul. 3, 2002 in the name of Houser et al., Office Action mailed Dec. 16, 2009.
European Patent Application No. 02749755.1 filed Jul. 3, 2002 in the name of Houser et al., Office Action mailed Mar. 1, 2011.
European Patent Application No. 02749755.1 filed Jul. 3, 2002 in the name of Houser et al., Search Report mailed Sep. 16, 2009.
Infoconomy Staff, "Enterprise Search Tools", http://www.infoconomy.com/pages/infoconomist-crib-sheets/group101866.adp, World Wide Web, Dec. 1, 2004, pp. 1-5.
Japanese Patent Application No. 2001-505831 filed Jun. 23, 2000 in the name of Saadat et al., Notice of Allowance mailed Jun. 29, 2010.
Japanese Patent Application No. 2001-505831 filed Jun. 23, 2000 in the name of Saadat et al., office action mailed Jan. 12, 2010.
Min Wang et. al., "Database Research at Watson", http://www.research.ibm.com/scalabledb/semistruct.html, World Wide Web, May 25, 2005, pp. 1-3.
Naseef III, G. S. etal. (1997). "The Thermal Properties of Bovine Joint Capsule, The Basic Science of Laser-and Radiofrequency-Induced Capsular Shrinkage", The American Journal ofSports Medicine, 25(5):670-674.
PCT International Search Report for PCT/US2005/007108, Applicant Hansen Medical, Inc., Forms PCTIISAI210 and 220, dated Jun. 26, 2005 (9 pages).
PCT Patent Application No. PCT/US2000/017270 filed Jun. 23. 2000 in the name of Saadat, Search Report mailed Oct. 12, 2000.
PCT Patent Application No. PCT/US2002/020996 filed Jul. 3, 2002 in the name of Houser et al., Search Report mailed Sep. 19, 2002.
PCT Patent Application No. PCT/US2005/028877 filed Aug. 12, 2005 in the name of Moll et al., Search Report and Written Opinion mailed Nov. 22, 2005.
PCT Patent Application No. PCT/US2006/044655 filed Nov. 15, 2006 in the name of Loulmet, Search Report and Written Opinion mailed May 1, 2007.
PCT Written Opinion of the International Search Authority for PCT/US2005/007108, Applicant Hansen Medical, Inc., Form PCT/ISAI237, dated Jun. 26, 2005 (6 pages).
Penny Lunt Lunt Crosman, "Content Pipeline", http://messagingpipeline.com/shared/article/printableArticleSrc.jhtml?articleId=51201811>, World Wide Web, Nov. 1, 2004, pp. 1-8.
Robert Bourret, "Persistence: SGML and XML in Databases", http://www.isgmlug.org/database.html, World Wide Web, 2002, pp. 1-5.
Robert D. Kugel, "Transform Magazine: Unstructured Information Management", http://www.transformmag.com/shard/cp/print-article.jthml:sessionid. >, World Wide Web, Dec. 2003, pp. 1-3.
Robert D. Kugel, "Transform Magazine: Unstructured Information Management", http://www.transformmag.com/shard/cp/print—article.jthml:sessionid. >, World Wide Web, Dec. 2003, pp. 1-3.
Selecky, M. T. et al. (1996). "The Effects of Laser-Induced Collagen Shortening on the Biomechanical Properties of the Inferior Glenohumeral Ligament Complex", Univety of Southern California, School of Medicine, Department of Orthopaedic Surgery, Los Angeles, California, 90033, pp. 1-25.
Stephen Swoyer, "IBM's BI Middleware Play: Its All About Integration, Partnerships", http://www.tdwi.org/Publications/display.aspx?id+7267&t=y, World Wide Web, Nov. 3, 2004, pp. 1-3.
U.S. Appl. No. 09/602,436 filed Jun. 23, 2000 in the name of Saadat, non-final Office Action mailed Jan. 29, 2003.
U.S. Appl. No. 09/602,436 filed Jun. 23, 2000 in the name of Saadat, non-final Office Action mailed Jul. 16, 2002.
U.S. Appl. No. 09/602,436 filed Jun. 23, 2000 in the name of Saadat, non-final Office Action mailed Mar. 29, 2002.
U.S. Appl. No. 09/602,436 filed Jun. 23, 2000 in the name of Saadat, Notice of Allowance mailed Sep. 12, 2003.
U.S. Appl. No. 09/898,726 filed Jul. 3, 2001 in the name of Houser et al., final Office Action mailed Feb. 26, 2003.
U.S. Appl. No. 09/898,726 filed Jul. 3, 2001 in the name of Houser et al., non-final Office Action mailed Sep. 25, 2002.
U.S. Appl. No. 09/898,726 filed Jul. 3, 2001 in the name of Houser et al., Notice of Allowance mailed Jun. 2, 2003.
U.S. Appl. No. 10/188,509 filed Jul. 3, 2002 in the name of Saadat, final Office Action mailed Mar. 3, 2006.
U.S. Appl. No. 10/188,509 filed Jul. 3, 2002 in the name of Saadat, non-final Office Action mailed Feb. 12, 2004.
U.S. Appl. No. 10/188,509 filed Jul. 3, 2002 in the name of Saadat, non-final Office Action mailed Jul. 27, 2005.
U.S. Appl. No. 10/188,509 filed Jul. 3, 2002 in the name of Saadat, non-final Office Action mailed Nov. 5, 2004.
U.S. Appl. No. 10/188,509 filed Jul. 3, 2002 in the name of Saadat, Notice of Allowance mailed Sep. 19, 2006.
U.S. Appl. No. 10/669,204 filed Sep. 23, 2003 in the name of Houser et al., final Office Action mailed Feb. 9, 2005.
U.S. Appl. No. 10/669,204 filed Sep. 23, 2003 in the name of Houser et al., final Office Action mailed Jul. 14, 2006.
U.S. Appl. No. 10/669,204 filed Sep. 23, 2003 in the name of Houser et al., non-final Office Action mailed May 18, 2004.
U.S. Appl. No. 10/669,204 filed Sep. 23, 2003 in the name of Houser et al., non-final Office Action mailed Nov. 22, 2005.
U.S. Appl. No. 10/669,204 filed Sep. 23, 2003 in the name of Houser et al., Notice of Allowance mailed Jan. 8, 2007.
U.S. Appl. No. 11/073,363 filed Mar. 4, 2005 in the name of Wallace et al., Final Office Action mailed Dec. 21, 2010.
U.S. Appl. No. 11/073,363 filed Mar. 4, 2005 in the name of Wallace et al., Non-final Office Action mailed Jun. 8, 2010.
U.S. Appl. No. 11/073,363 filed Mar. 4, 2005 in the name of Wallace et al., Notice of Allowance mailed Mar. 10, 2011.
U.S. Appl. No. 11/073,363, filed Mar. 4, 2005 in the name of Wallace et al., Final Office Action mailed Jan. 21, 2010.
U.S. Appl. No. 11/073,363, filed Mar. 4, 2005 in the name of Wallace et al., Non-final Office Action mailed Jun. 10, 2009.
U.S. Appl. No. 11/176,957 filed Jul. 6, 2005 in the name of Wallace et al., Final Office Action mailed Oct. 26, 2010.
U.S. Appl. No. 11/176,957 filed Jul. 6, 2005 in the name of Wallace et al., Non-final Office Action mailed May 10, 2010.
U.S. Appl. No. 11/176,957 filed Jul. 6, 2005 in the name of Wallace et al., Notice of Allowance mailed Mar. 17, 2011.
U.S. Appl. No. 11/202,925 filed Aug. 12, 2005 in the name of Hlavka et al., final Office Action mailed Oct. 27, 2010.
U.S. Appl. No. 11/202,925 filed Aug. 12, 2005 in the name of Hlavka et al., non-final Office Action mailed May 11, 2010.
U.S. Appl. No. 11/202,925 filed Aug. 12, 2005 in the name of Hlavka et al., Notice of Allowance mailed Apr. 12, 2011.
U.S. Appl. No. 11/286,037 filed Nov. 23, 2005 in the name of Loulmet, non-final Office Action mailed Jan. 15, 2009.
U.S. Appl. No. 11/286,037 filed Nov. 23, 2005 in the name of Loulmet, Notice of Allowance mailed Sep. 17, 2009.
U.S. Appl. No. 11/622,442 filed Jan. 11, 2007 in the name of Saadat, Non-final Office Action mailed Jun. 25, 2008.
U.S. Appl. No. 11/622,442 filed Jan. 11, 2007 in the name of Saadat, Notice of Allowance mailed Mar. 23, 2009.
U.S. Appl. No. 11/743,343 filed May 2, 2007 in the name of Houser et al., Final Office Action mailed May 5, 2010.
U.S. Appl. No. 11/743,343 filed May 2, 2007 in the name of Houser et al., non-final Office Action mailed Jul. 21, 2009.
U.S. Appl. No. 12/489,258 filed Jun. 22, 2009 in the name of Saadat, Non-Final Office Action mailed Feb. 15, 2011.
U.S. Appl. No. 12/608,849 filed Oct. 29, 2009 in the name of Loulmet, Final Office Action mailed Mar. 23, 2011.
U.S. Appl. No. 12/608,849 filed Oct. 29, 2009 in the name of Loulmet, non-final Office Action mailed Jun. 24, 2010, 2010.

References: §119
 Application No. 00944803
 Application No. 00944803
 Application No. 00944803
 Application No. 00944803
 Application No. 02749755
 Application No. 02749755
 Application No. 02749755
 Application No. 2001
 Application No. 2001