The present disclosure pertains to interventional medical systems, and more particularly to relatively compact implantable medical devices thereof and associated methods.
The traditional implantable cardiac pacemaker includes a pulse generator device to which one or more flexible elongate lead wires are coupled. The device is typically implanted in a subcutaneous pocket, remote from the heart, and each of the one or more lead wires extends therefrom to a corresponding electrode, coupled thereto and positioned at a pacing site, either endocardial or epicardial. Mechanical complications and/or MM compatibility issues, which are sometimes associated with elongate lead wires and well known to those skilled in the art, have motivated the development of implantable cardiac pacing devices that are wholly contained within a relatively compact package, the entirety of which is configured for implant in close proximity to the pacing site.
A relatively compact implantable medical device, according to embodiments of interventional medical systems disclosed herein, includes a fixation member formed by a plurality of fingers mounted around a perimeter of a distal end of a housing of the device; each finger is elastically deformable from a relaxed condition to an extended condition, to accommodate delivery of the device to a target implant site, and from the relaxed condition to a compressed condition, to accommodate wedging of the fingers between opposing tissue surfaces at the target implant site, wherein the compressed fingers hold a cardiac pacing electrode of the device in intimate tissue contact for the delivery of pacing stimulation from the implanted device to the site. According to some methods, after an operator navigates a delivery tool, which has the device loaded within a distal-most portion of a deployment tube thereof, through a venous system of the patient, to locate the distal-most portion of the tool in proximity to a target implant site, the operator retracts the deployment tube with respect to the loaded device to expose the fixation fingers out through a distal opening of the lumen of the deployment tube, so that the fixation fingers are released from the extended condition to the relaxed condition; and then the operator advances the delivery tool toward the target site to wedge the exposed fixation fingers between opposing tissue surfaces at the target implant site, thereby compressing the fixation fingers, so that the compressed fingers, by a spring force thereof, hold the pacing electrode of the device in intimate tissue contact.
Each finger of the device fixation member, according to some embodiments, includes a first segment, which extends from a fixed end of the corresponding finger, and a second segment that extends from the first segment to a free end of the corresponding finger, wherein each second segment extends in a distal direction, when the first segment of each finger is in the extended condition, and extends in a proximal direction, outward from the device housing, when the first segment of each finger is in the relaxed condition. Furthermore, the second segment of each fixation finger is preferably configured to prevent penetration thereof within the tissue when the fingers are compressed and wedged between opposing tissue surfaces.
According to some preferred embodiments, the pacing electrode of the device is mounted on a pacing extension of the device, wherein the pacing extension extends distally from the distal end of the device housing. When the device is loaded in the distal-most portion of the aforementioned delivery tool, an entirety of the pacing extension may be contained within the distal-most portion, along with a remainder of the device and the distal end of the inner member of the tool, which abuts a proximal end of the device housing, and each fixation finger, in the extended condition, extends in a distal direction alongside the pacing extension. According to some embodiments and methods, after navigating the delivery tool to locate the distal-most portion of the tool in proximity to the target implant site, the operator can retract the deployment tube only enough to expose the pacing electrode of the pacing extension without exposing the fixation fingers, and then advance the delivery tool toward the target site until the exposed electrode comes into contact with tissue at the site, so that the operator can evaluate pacing performance at the site. If pacing performance is acceptable at the site, the operator can pull the tool and loaded device back away from the site, retract the deployment tube even further, with respect to the loaded device, to expose the fixation fingers, and then advance the tool again toward the site to wedge the exposed fixation fingers between opposing tissue surfaces at the target implant site, thereby compressing the fixation fingers, so that the compressed fingers hold the pacing electrode in intimate tissue contact.
The following drawings are illustrative of particular embodiments of the present invention and therefore do not limit the scope of the invention. The drawings are not to scale (unless so stated) and are intended for use in conjunction with the explanations in the following detailed description. Embodiments will hereinafter be described in conjunction with the appended drawings wherein like numerals denote like elements, and:
The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the following description provides practical examples, and those skilled in the art will recognize that some of the examples may have suitable alternatives.
According to the illustrated embodiment, first segment 231 of each fixation finger 230 is elastically deformable between the relaxed condition and an extended condition, per arrow E of
With further reference to
According to some methods of the present invention, once an operator has located distal-most portion 332 in a chamber of the heart, for example, the right atrium RA, as shown in
After wedging fingers 230 between opposing tissue surface, the operator may evaluate pacing performance of electrode 261 before completely withdrawing delivery tool 300 away from the implanted device 200. Thus, if the operator determines that the performance is not satisfactory, the operator may advance distal-most portion 332 of deployment tube 330 back in a distal direction, for example, via control member 312 (
Turning now to
According to the illustrated embodiment, fixation fingers 730 are formed from a flexible polymer material, for example, medical grade silicone rubber or polyurethane, and, in a relaxed condition, extend proximally from distal end 201 of device housing 205, and outward therefrom at an angle α relative to a longitudinal axis of device housing 205. Angle α may be approximately 60 degrees, and a length of each finger 730, from a fixed end 735 to a free end 736 thereof, may be approximately 0.2 inch (5 mm). Like the above described fixation fingers 230, fingers 730 are configured to hold electrode 761 in intimate tissue contact at a target implant site, for example, within right atrial appendage 102 or within right ventricle RV in proximity to apex 103 (
In the foregoing detailed description, the invention has been described with reference to specific embodiments. However, it may be appreciated that various modifications and changes can be made without departing from the scope of the invention as set forth in the appended claims.
The present application is a continuation of U.S. patent application having the Ser. No. 14/518,261, which was filed on Oct. 20, 2014, and claims the benefit of U.S. Provisional Patent Application having the Ser. No. 62/041,954, which was filed on Aug. 26, 2014. Application Ser. Nos. 14/518,261 and 62/041,954 are hereby incorporated by reference in their entirety. The present application is related to commonly assigned U.S. patent application Ser. No. 14/518,211, which was filed on Oct. 20, 2014 and entitled INTERVENTIONAL MEDICAL SYSTEMS, DEVICES, AND COMPONENTS THEREOF, and which is incorporated by reference in its entirety.
Number | Name | Date | Kind |
---|---|---|---|
3814104 | Irnich et al. | Jun 1974 | A |
3835864 | Rasor | Sep 1974 | A |
3902501 | Citron et al. | Sep 1975 | A |
3939843 | Smyth | Feb 1976 | A |
3943936 | Rasor et al. | Mar 1976 | A |
4103690 | Harris | Aug 1978 | A |
4142530 | Wittkampf | Mar 1979 | A |
4269198 | Stokes | May 1981 | A |
4280512 | Karr | Jul 1981 | A |
4424551 | Stevenson et al. | Jan 1984 | A |
4858623 | Bradshaw et al. | Aug 1989 | A |
4936823 | Colvin | Jun 1990 | A |
5184625 | Cottone, Jr. et al. | Feb 1993 | A |
5193540 | Schulman et al. | Mar 1993 | A |
5411535 | Fujii et al. | May 1995 | A |
5492119 | Abrams | Feb 1996 | A |
5573540 | Yoon | Nov 1996 | A |
5642736 | Avitall | Jul 1997 | A |
5683447 | Bush et al. | Nov 1997 | A |
5836960 | Kolesa et al. | Nov 1998 | A |
5916214 | Cosio et al. | Jun 1999 | A |
6007558 | Ravenscroft et al. | Dec 1999 | A |
6151525 | Soykan et al. | Nov 2000 | A |
6152144 | Lesh et al. | Nov 2000 | A |
6240322 | Peterfeso et al. | May 2001 | B1 |
6286512 | Loeb et al. | Sep 2001 | B1 |
6409674 | Brockway et al. | Jun 2002 | B1 |
6575967 | Leveen et al. | Jun 2003 | B1 |
6582443 | Cabak et al. | Jun 2003 | B2 |
6716238 | Elliott | Apr 2004 | B2 |
6783499 | Schwartz | Aug 2004 | B2 |
6915149 | Ben-Haim | Jul 2005 | B2 |
6941169 | Pappu | Sep 2005 | B2 |
6978178 | Sommer et al. | Dec 2005 | B2 |
7149587 | Wardle et al. | Dec 2006 | B2 |
7290743 | Nowack | Nov 2007 | B2 |
7418298 | Shiroff et al. | Aug 2008 | B2 |
7497844 | Spear et al. | Mar 2009 | B2 |
7509169 | Eigler et al. | Mar 2009 | B2 |
7515971 | Doan | Apr 2009 | B1 |
7566336 | Corcoran et al. | Jul 2009 | B2 |
7623899 | Worley et al. | Nov 2009 | B2 |
7647124 | Williams | Jan 2010 | B2 |
8032220 | Kuzma | Oct 2011 | B2 |
8353940 | Benderev | Jan 2013 | B2 |
8473023 | Worley et al. | Jun 2013 | B2 |
8500733 | Watson | Aug 2013 | B2 |
8634919 | Hou et al. | Jan 2014 | B1 |
8795328 | Miles et al. | Aug 2014 | B2 |
9119959 | Rys et al. | Sep 2015 | B2 |
9155882 | Grubac et al. | Oct 2015 | B2 |
9283381 | Grubac et al. | Mar 2016 | B2 |
9526522 | Wood et al. | Dec 2016 | B2 |
9675798 | Grubac et al. | Jun 2017 | B2 |
10071243 | Kuhn et al. | Sep 2018 | B2 |
10478620 | Eggen et al. | Nov 2019 | B2 |
20020103424 | Swoyer et al. | Aug 2002 | A1 |
20020165537 | Kelley et al. | Nov 2002 | A1 |
20020165589 | Imran et al. | Nov 2002 | A1 |
20020183823 | Pappu | Dec 2002 | A1 |
20020183824 | Borgersen et al. | Dec 2002 | A1 |
20030088301 | King | May 2003 | A1 |
20040133089 | Kilcoyne et al. | Jul 2004 | A1 |
20040147973 | Hauser | Jul 2004 | A1 |
20040215307 | Michels et al. | Oct 2004 | A1 |
20040230281 | Heil et al. | Nov 2004 | A1 |
20050004602 | Hart et al. | Jan 2005 | A1 |
20050004641 | Pappu | Jan 2005 | A1 |
20050004644 | Kelsch et al. | Jan 2005 | A1 |
20050136385 | Mann et al. | Jun 2005 | A1 |
20060084965 | Young | Apr 2006 | A1 |
20060085039 | Hastings et al. | Apr 2006 | A1 |
20060085041 | Hastings et al. | Apr 2006 | A1 |
20060247753 | Wenger et al. | Nov 2006 | A1 |
20070083230 | Javois | Apr 2007 | A1 |
20070156114 | Worley et al. | Jul 2007 | A1 |
20070219590 | Hastings et al. | Sep 2007 | A1 |
20080057100 | Williams et al. | Mar 2008 | A1 |
20090082828 | Ostroff | Mar 2009 | A1 |
20100094314 | Hernlund et al. | Apr 2010 | A1 |
20100228279 | Miles et al. | Sep 2010 | A1 |
20100274227 | Khairkhahan et al. | Oct 2010 | A1 |
20110144572 | Kassab et al. | Jun 2011 | A1 |
20110251660 | Griswold | Oct 2011 | A1 |
20120059448 | Parker et al. | Mar 2012 | A1 |
20120172690 | Anderson et al. | Jul 2012 | A1 |
20120172892 | Grubac | Jul 2012 | A1 |
20120197373 | Khairkhahan et al. | Aug 2012 | A1 |
20130035748 | Bonner | Feb 2013 | A1 |
20130079798 | Tran et al. | Mar 2013 | A1 |
20130103047 | Steingisser et al. | Apr 2013 | A1 |
20130131591 | Berthiaume et al. | May 2013 | A1 |
20130131693 | Berthiaume et al. | May 2013 | A1 |
20130253347 | Griswold et al. | Sep 2013 | A1 |
20140039591 | Drasler et al. | Feb 2014 | A1 |
20150039070 | Kuhn et al. | Feb 2015 | A1 |
20150051611 | Schmidt et al. | Feb 2015 | A1 |
20150253347 | Cong et al. | Sep 2015 | A1 |
20150352353 | Rys et al. | Dec 2015 | A1 |
20160015322 | Anderson et al. | Jan 2016 | A1 |
20160059003 | Eggen et al. | Mar 2016 | A1 |
20170274202 | Grubac et al. | Sep 2017 | A1 |
Number | Date | Country |
---|---|---|
1365702 | Dec 2003 | EP |
1670360 | Jun 2006 | EP |
2002022202 | Mar 2002 | WO |
02071977 | Sep 2002 | WO |
2004028348 | Apr 2004 | WO |
2005034764 | Apr 2005 | WO |
2006118865 | Nov 2006 | WO |
2013043671 | Mar 2013 | WO |
2013062793 | May 2013 | WO |
2015017157 | Feb 2015 | WO |
Entry |
---|
Haqqani et al., “The Implantable Cardioverter-Defibrillator Lead: Principles, Progress and Promises,” PACE, vol. 32, Oct. 2009, pp. 1336-1353. |
Tjong et al., “Acute and 3-Month Performance of a Communicating Leadless Antitachycardia Pacemaker and Subcutaneous Implantable Defibrillator,” JACC: Clinical Electrophysiology, vol. 3, No. 13, Dec. 26, 2017, pp. 1487-1498. |
Tjong et al., “The modular cardiac rhythm management system: the EMPOWER leadless pacemaker and the EMBLEM subcutaneous ICD,” Herzschrittmachertherapie + Elektrophysiologie, vol. 29, Oct. 31, 2018, pp. 355-361. |
(PCT/US2014/057596) PCT Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority, dated Dec. 5, 2014, 12 pages. |
(PCT/US2015/040870) PCT Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority, dated Oct. 14, 2015, 10 pages. |
(PCT/US2015/043957) PCT Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority, dated Nov. 11, 2015, 9 pages. |
(PCT/US2014/057727) PCT Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority, dated Dec. 8, 2014, 12 pages. |
Eggen et al., “Interventional Medical Systems, Devices, and Methods of Use” Chinese Patent Application No. 201580045776.8 First Office Action dated Sep. 29, 2018, 7 pages. |
Prosecution History from U.S. Appl. No. 14/518,261, dated Mar. 23, 2017 through Jul. 12, 2019, 145 pp. |
Response to Written Opinion dated Nov. 11, 2015, from International Application No. PCT/US2014/010345, dated Jun. 27, 2016, 8 pp. |
International Preliminary Report on Patentability from International Application No. PCT/US2015/043957, dated Jul. 27, 2016, 5 pp. |
Text Intended to Grant from counterpart European Application No. 15753548.5, dated Jul. 24, 2017, 60 pp. |
First Office Action and Search Report, and translation thereof, from counterpart Chinese Application No. 201580045776.8, dated Aug. 3, 2018, 8 pp. |
Number | Date | Country | |
---|---|---|---|
20200078585 A1 | Mar 2020 | US |
Number | Date | Country | |
---|---|---|---|
62041954 | Aug 2014 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 14518261 | Oct 2014 | US |
Child | 16686617 | US |