The present disclosure pertains to implantable medical systems, and more particularly to implantable medical therapy delivery devices, such as electrical stimulation leads or drug delivery catheters, and fixation components thereof.
An implantable medical system that provides therapy, for example, cardiac or neurological therapy, often includes an elongate insulative body configured to extend within a patient's body to a target site and to deliver a therapy to the target site. The therapy may be electrical stimulation therapy, drug therapy (e.g., delivery of a therapeutic agent), other therapy or a combination of therapies.
Embodiments of implantable therapy delivery devices, such as electrical stimulation leads or drug delivery catheters are disclosed herein. According to one embodiment, an implantable therapy delivery device includes an elongate insulative body having an outer surface and a non-conductive filament extending along a length of the outer surface of an insulative body of the device. The filament includes a plurality of fixation projections and is secured to the outer surface of the insulative body such that at least a portion of the plurality of projections protrude outward from the outer surface and are spaced apart from one another along the length of the outer surface.
The filament may be wound about the length with an open pitch, and/or, in some embodiments, the filament is interlaced with an open-work member that forms at least a portion of the length of the outer surface of the insulative body. According to some embodiments, the open-work member may overlap one or more electrodes of at least one electrode circuit of the device, and, in some cases, may further form another length of the outer surface of the insulative body that extends proximally from the secured filament.
According to another embodiment, an implantable medical device system comprises an implantable stimulation device and an implantable stimulation lead, the device and lead being adapted for coupling to one another. The stimulation lead includes an elongate insulative body including a proximal segment, a distal segment, and a pre-formed bend extending therebetween, a stimulation electrode circuit, at least one sense electrode circuit. The stimulation and sense electrode circuits being supported by the insulative body, the distal segment of the insulative body having electrodes of the stimulation electrode circuit and the at least one sense electrode circuit mounted thereabout. The stimulation lead also includes a non-conductive filament including a plurality of fixation projections and extending along a length of an outer surface of the pre-formed bend and distal segment of the insulative body, the filament being wound about all or a portion of the length with an open pitch and being secured to the outer surface such that the projections thereof protrude outward from the outer surface and are spaced apart from one another along the length of the outer surface.
The insulative body of the lead may further include one or more open-work members to form all or a portion of the length of the outer surface along which the fiber extends, the fiber being interlaced therewith. In some embodiments that include a single open-work member to form the length of the outer surface along which the fiber extends, the open-work member may also form another length of the outer surface of the insulative body that extends proximally from the pre-formed bend.
In those embodiments that include both the non-conductive filament and the open-work member, the filament may be bioabsorbable, for example, to provide only acute fixation via the projections thereof, while the open-work member provides a structure for tissue ingrowth and, thus, more permanent or chronic fixation. Some embodiments of components for forming a length of an outer surface of an implantable therapy delivery device include a tubular open-work member and a non-conductive filament interlaced therewith, wherein the filament includes a plurality of fixation projections, at least a portion of which protrude outward from the open-work member.
In another embodiment, the disclosure provides a component for forming a length of an outer surface of an elongate insulative body of an implantable medical lead. The component includes a tubular open-work member and a non-conductive filament including a plurality of fixation projections, the filament being interlaced with the open-work member such that the plurality of projections protrude outward from the open-work member.
Although the disclosed embodiments are described in the context of the above-referenced subcutaneously implantable defibrillation system, it should be understood that embodiments of the present invention are not so limited and may be employed by other types of implantable devices that include elongate insulative bodies, for example, suitable for implantation in other sites of a patient's body, either for the delivery of electrical stimulation or for the delivery of therapeutic drugs.
The following drawings are illustrative of particular embodiments 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/letters denote like elements.
The implanted pulse generator 10 is shown located within a subcutaneous pocket formed in proximity to the patient's left axilla and infra-mammary crease, and the implanted lead 100 is shown extending within a subcutaneously formed tunnel that extends medially above the ribcage from pulse generator 10, into proximity with the sternum, approximately level with the xiphoid, and then superiorly above the sternum and/or ribcage along the left side of the sternum. An implanted medical system in which both the pulse generator 10 and lead 100 are implanted subcutaneously above the ribcage and/or sternum is referred to herein as a subcutaneous system.
Implantable stimulation pulse generator 10 and lead 100 may, however, be implanted at other locations within the patient. For example, in another example, lead 100 may extend medially from pulse generator 10, into proximity with the sternum, approximately level with the xiphoid, and then superiorly underneath/below the sternum and/or ribcage (e.g., on the posterior side of the sternum and/or ribcage) in the substernal space, which includes the anterior mediastinum. An example system including such a substernal lead is described in detail U.S. patent application Ser. No. 14/261,470 filed on Apr. 25, 2014 and titled, “IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) SYSTEM INCLUDING SUBSTERNAL LEAD,” the content of which is incorporated by reference herein in its entirety. An implanted medical system in which the distal portion of lead 100 is implanted underneath/below the sternum and/or the ribcage is referred to herein as a substernal system.
In the example of
Those skilled in the art appreciate the importance of fixing the implanted lead 100 at the target site, for example, in order to maintain a stable location of electrodes e1, e2, e3 relative to the heart of the patient, and relative to the implanted pulse generator 10. Likewise, any other type of implantable therapy delivery device that includes an elongate body like lead 100 benefits from stable fixation. Typical subcutaneous fixation methods involve manually suturing portions of delivery devices to the subcutaneous tissue, and these methods may require multiple and/or enlarged incisions to provide adequate access for the suturing process. Lead 100 of
The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the disclosure 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. For example, the fixation structures described herein may be used in conjunction with other implantable medical therapy delivery devices. For example, the fixation structures described herein may be used with electrical stimulation leads used to electrical stimulation therapy to a spine, brain, bladder, or other anatomical location within the body. As another example, the fixation structures described herein may be used with drug delivery catheters that provide a therapeutic agent to a location within the patient.
According to an exemplary embodiment, strand portion 20 has a diameter between approximately 0.1 mm and approximately 1 mm, wherein each fixation projection 205 is barb-like and has a length between approximately 0.004 inch and approximately 0.080 inch, and projections 205 are spaced apart, along a length of filament 200, for example, by a distance of between approximately 0.005 inch and approximately 0.5 inch.
According to the illustrated embodiment, projections 205 are oriented such that an extension of each, from fixed to free end, is in a proximal direction along the length of outer surface 355. Thus, the orientation of projections 205 will not impede the movement of lead 300 through a cannula, if lead 300 is implanted by pushing lead 300, with a distal end 345 of insulative body 350 leading, through the cannula, for example, having been introduced via a percutaneous axillary incision site to form the above described tunnel for the implant configuration of
Elongate electrically isolated conductors (not shown) extend within insulative body 350 of lead 300, each coupling a corresponding electrode e1, e2, e3 to a corresponding lead contact c1, c2, c3 to form the aforementioned electrode circuits. With reference to
In some instances, filament 200 may be interlaced with open-work member 60, for example, to secure filament 200 to outer surface 455. The interlacing may be accomplished by stitching filament 200 through apertures, or interstices of open-work member 60, or by braiding or weaving filament into a structure of open-work member 60 as it is initially formed. A minimum length of outer surface 455 that is formed by open-work member 60 may be approximately 0.25 inch in some embodiments, and open-work member 60 is relatively flexible and soft, or compliant, so that member 60 does not significantly increase a stiffness of insulative body 450.
Open-work member 60 may be a perforated tube (e.g.,
With further reference to
Open-work member 60 is preferably biostable, or non-bioabsorbable, and interstices, or apertures, of open-work member 60 are exposed to provide spaces along outer surface 455, 555, 755 of insulative body 450, 550, 750 for tissue ingrowth when lead 400, 500, 700 is implanted, for example, subcutaneously in the configuration shown in
According to some embodiments, open-work members 60A, 60B, like open-work member 60 described above, are biostable, or non-bioabsorbable, while filament 200 that is employed therewith, is bioabsorbable, as described above in conjunction with
The foregoing detailed description 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.
This application is a continuation of U.S. patent application Ser. No. 15/963,411, filed Apr. 26, 2018 (now allowed), entitled “IMPLANTABLE MEDICAL DEVICES, SYSTEMS AND COMPONENTS THEREOF,” which is a divisional of U.S. patent application Ser. No. 14/283,278, filed May 21, 2014 (now allowed), entitled “IMPLANTABLE MEDICAL DEVICES, SYSTEMS AND COMPONENTS THEREOF,” which claims the benefit of U.S. Provisional Application No. 61/984,900, filed Apr. 28, 2014, entitled “IMPLANTABLE MEDICAL DEVICES, SYSTEMS AND COMPONENTS THEREOF,” the entire content of all of which are incorporated herein by reference in their entirety.
Number | Name | Date | Kind |
---|---|---|---|
3123077 | Alcamo | Mar 1964 | A |
5476493 | Muff | Dec 1995 | A |
5984896 | Boyd | Nov 1999 | A |
7021086 | Ory et al. | Apr 2006 | B2 |
7212869 | Wahlstrom et al. | May 2007 | B2 |
7270669 | Sra | Sep 2007 | B1 |
7319905 | Morgan et al. | Jan 2008 | B1 |
8086324 | Vase | Dec 2011 | B1 |
8246652 | Ruff | Aug 2012 | B2 |
8353931 | Stopek et al. | Jan 2013 | B2 |
9981121 | Seifert et al. | May 2018 | B2 |
10279165 | Seifert et al. | May 2019 | B2 |
20020035331 | Brockway et al. | Mar 2002 | A1 |
20030105501 | Warman et al. | Jun 2003 | A1 |
20040039415 | Zamierowski | Feb 2004 | A1 |
20040230279 | Cates et al. | Nov 2004 | A1 |
20050033394 | Seifert et al. | Feb 2005 | A1 |
20070239244 | Morgan et al. | Oct 2007 | A1 |
20080009914 | Buysman et al. | Jan 2008 | A1 |
20080077220 | Reddy | Mar 2008 | A1 |
20100152798 | Sanghera et al. | Jun 2010 | A1 |
20110009935 | Kane et al. | Jan 2011 | A1 |
20110130774 | Criscuolo et al. | Jun 2011 | A1 |
20120029335 | Sudam et al. | Feb 2012 | A1 |
20120046515 | Woo et al. | Feb 2012 | A1 |
20120316627 | Finlay et al. | Dec 2012 | A1 |
20130030511 | Bardy et al. | Jan 2013 | A1 |
20140025094 | Glick et al. | Jan 2014 | A1 |
20140330327 | Thompson-Nauman et al. | Nov 2014 | A1 |
Number | Date | Country |
---|---|---|
2004028621 | Apr 2004 | WO |
2005077451 | Aug 2005 | WO |
2008094952 | Aug 2008 | WO |
2013025678 | Feb 2013 | WO |
2013049787 | Apr 2013 | WO |
Entry |
---|
V-LocTM Wound Closure Devices Product Overview, 2 pages, Covidien, Covidien with logo, Covidien logo and positive results for life are U .S.and/or internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. © 2011 Covidien. 11.11 P100049. |
(PCT/US2015/025864) PCT Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority, dated Jul. 7, 2015, 11 pages. |
ProGrip″′ Laparascopic Self-Fixating Mesh—Value Analysis Committee—Product Information Kit, Covidien, 23 pages, vidien with logo, Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. TM⋅ Trademark of its respective owner. Other brands are trademarks of a Covidien company. © 2013 Covidien 1.13 M130037. |
QuiiiTM Knotless Tissue-Closure Device Product Catalog, 12 pages. QuiiiDevice.com; Quill 0104R6 11/13 Quill TM and MONODERMTM are trademarks of Surgical Specialties Corporation. © 2007-2013 Surgical Specialties Corporation. |
Prosecution History from U.S. Appl. No. 14/283,278, dated Jul. 18, 2016 through Jan. 24, 2018, 45 pp. |
Prosecution History from U.S. Appl. No. 15/963,411, dated Aug. 2, 2018 through Dec. 12, 2018, 22 pp. |
Number | Date | Country | |
---|---|---|---|
20190255314 A1 | Aug 2019 | US |
Number | Date | Country | |
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61984900 | Apr 2014 | US |
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Parent | 14283278 | May 2014 | US |
Child | 15963411 | US |
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Parent | 15963411 | Apr 2018 | US |
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