By a News Reporter-Staff News Editor at Drug Week — A patent application by the inventors Behymer, Bruce A. (Grant, MN); Silverberg, Jacob W. (Blaine, MN); Klardie, Michael R. (Bloomington, MN); Kern, Michael J. (St. Louis Park, MN), filed on December 27, 2013, was made available online on July 3, 2014, according to news reporting originating from Washington, D.C., by NewsRx correspondents (see also Medtronic, Inc.).
This patent application is assigned to Medtronic, Inc.
The following quote was obtained by the news editors from the background information supplied by the inventors: “Implantable medical catheters and leads have been employed for a variety of therapeutic and diagnostic purposes. Controlled placement of such therapy delivery elements within in a patient is highly desirable, as precise placement may result in improved therapeutic efficacy or reduced side effects. However, the location of the delivery element may change in time. As the patient moves, the location of the implanted delivery element may move.
“Anchors, which are typically placed about the delivery element and sutured to subcutaneous tissue of the patient, are employed to secure the position of a delivery region, e.g. infusion section or electrode, of the delivery element; e.g. catheter or lead, relative to a target location of the patient. However, existing anchors may suffer from one or more drawbacks, including (i) ineffective gripping of an implanted therapy delivery element when subjected to stresses associated patient movement, and (ii) awkward techniques for placing the anchor about the delivery element or for suturing the anchor to tissue.”
In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors’ summary information for this patent application: “The present disclosure describes, among other things, anchors, anchor deployment apparatuses, kits, systems and methods that provide for effective gripping of a therapy delivery element or simple delivery of an anchor.
“In an embodiment, an anchor for maintaining a portion of a therapy delivery element within a desired location of a patient is described. The therapy delivery element has an outer diameter and an outer surface about which the anchor is disposable. The anchor includes (i) a first opening, (ii) a second opening, (iii) a body member formed from elastic material disposed between the first and second opening, (iv) a lumen extending though the body member from the first opening to the second opening, and (v) a retention element secured to or integrally formed with the body member for retaining the anchor within a tissue location of a patient. The lumen is configured to be disposed about at least a portion of the outer surface of the therapy delivery element. At least a portion of the body member has a first inner diameter defined by the lumen in a relaxed state and a second inner diameter defined by the lumen in a radially stretched state. The first inner diameter is smaller than the second inner diameter. The first inner diameter is configured to be smaller than the outer diameter of the therapy delivery element, and the second inner diameter is configured to be larger than the outer diameter of the therapy delivery element.
“In an embodiment, an anchor deployment apparatus for deploying an anchor about a therapy delivery element is described. The anchor deployment apparatus includes an anchor receiving element having an elongate member with a distal opening and a lumen extending proximally in the elongate member from the distal opening. The lumen of the elongate member is configured to slidably receive at least a portion of a therapy delivery element. The anchor deployment apparatus further includes an anchor engagement element having (i) a first channel in which the elongate member of the anchor receiving element is axially movable, and (ii) an engagement feature forming at least a part of the channel. The engagement feature is configured to engage the anchor when the anchor is disposed about the elongate member and the elongate member is moved distally relative to the engagement element, and to cause the anchor to move distally along the elongate member when the feature is engaged with the anchor and the elongate member is moved distally relative to the engagement element.
“In an embodiment, a system is described. The system includes an anchor having a first opening, a second opening, a body member disposed between the first and second opening, and a lumen extending though the body member from the first opening to the second opening. The body member is formed from an elastic material, and at least a portion of the body member has a first inner diameter defined by the lumen in a relaxed state and a second inner diameter defined by the lumen in a radially stretched state. The first inner diameter is smaller than the second inner diameter. The system further includes a therapy delivery element having an outer diameter and an outer surface about which the anchor is disposable. The outer diameter is larger than the first inner diameter of the at least a portion of the lumen of the anchor and smaller than the second inner diameter of the at least a portion of the lumen of the anchor. The system also includes an anchor deployment apparatus including an anchor receiving element. The anchor receiving element has an elongate member with a distal opening and a lumen extending proximally in the elongate member from the distal opening. The lumen of the elongate member is configured to slidably receive at least a portion of the therapy delivery element. The elongate member has an outer diameter larger than the first inner diameter of the at least a portion of the lumen of the anchor and smaller than the second inner diameter of the at least a portion of the lumen of the anchor such that the anchor is disposable about the elongate member and, when the anchor is disposed about the elongate member, the at least a portion of the lumen of the anchor engages at least a portion of the elongate member. The anchor is moveable about the elongate member and deployable about the therapy delivery element.
“In an embodiment, an anchor deployment apparatus for deploying an anchor about a therapy delivery element includes an anchor receiving element having an elongate member having a distal opening and a lumen extending proximally in the elongate member from the distal opening. The lumen of the elongate member is configured to slidably receive at least a portion of a therapy delivery element. The anchor deployment tool further includes an anchor engagement element having (i) a body forming a channel in which the elongate member of the anchor receiving element is axially movable, and (ii) an engagement feature forming at least a part of the channel. The engagement feature is configured to engage the anchor when the anchor is disposed about the elongate member and the elongate member is moved distally relative to the engagement element, and to cause the anchor to move distally along the elongate member when the feature is engaged with the anchor and the elongate member is moved distally relative to the engagement element. The anchor deployment tool also includes an alignment element secured relative to the elongate member and configured to secure the elongate member relative to the body of the anchor engagement element to restrict movement of the elongate member orthogonal to the axis of the channel. The anchor receiving element and the alignment element may be formed from the same or different parts.
“By providing anchors, anchor deployment apparatuses, kits, systems and methods that provide for effective gripping of a therapy delivery element or simple delivery of an anchor, therapeutic efficacy may be enhanced or complications may be reduced. These and other advantages will be readily understood from the following detailed descriptions when read in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
“FIG. 1 is a schematic drawing of a diagrammatic representation of a perspective view of an environment of an implantable medical system in a patient.
“FIGS. 2A-D are schematic drawings of diagrammatic representations of perspective views of environments of medical devices implanted in patients.
“FIG. 3A is a schematic drawing of a top view of an anchor.
“FIG. 3B is a schematic drawing of a cross-section of the anchor in FIG. 3a taken through line 3b-3b.
“FIGS. 3C-D are schematic drawings of head on back and front views of the anchor of FIG. 3A, as viewed along lines 3c and 3d, respectively.
“FIG. 4 is a schematic drawing of a top view of an embodiment of an anchor.
“FIG. 5A is a schematic drawing of a top view of a representative system including an anchor, anchor receiving element, and a therapy delivery element.
“FIG. 5B is a schematic drawing of a cross section taken through line 5b-5b of FIG. 5A.
“FIG. 5C is a schematic drawing of an exploded top view of the system of FIG. 5A.
“FIGS. 5D-E are a schematic drawings of head on front and back views of the anchor receiving element depicted in FIG. 5C as viewed along lines 5d and 5e, respectively.
“FIGS. 6A-B are schematic drawings of a representative system showing deployment of an anchor from about an anchor receiving element to about a therapy delivery element.
“FIG. 6C is a schematic drawing of a cross section of an anchor disposed about a therapy delivery element taken along line 6c-6c of FIG. 6B.
“FIG. 7A is a schematic drawing of a top view of a system including an anchor, a therapy delivery element, and an anchor deployment apparatus that includes an anchor receiving element and an anchor engagement element.
“FIG. 7B is a schematic drawing of an exploded top view of the system depicted in FIG. 7A.
“FIG. 7C is a schematic drawing of an exploded side view of the anchor engagement element and anchor receiving element shown in FIG. 7A.
“FIG. 7D is a schematic drawing of an opposing side view (relative to FIG. 7C) of the anchor engagement element shown in FIG. 7C.
“FIG. 7E is a schematic drawing of a cross section taken along line 7e-7e of FIG. 7A.
“FIG. 7F is a schematic drawing of a cross section taken along line 7f-7f of FIG. 7A.
“FIG. 7G is a schematic drawing of an alternative embodiment of a cross section taken along line 7e-7e of FIG. 7A.
“FIGS. 8A-C are schematic diagrams of top views of a system showing an anchor engagement element employed to move an anchor along an anchor receiving element and onto and about a therapy delivery element.
“FIG. 9 is a schematic drawing of a side view of a longitudinal section taken along line 9-9 of FIG. 8B.
“FIG. 10A is a schematic diagram of a side view of an anchor engagement element.
“FIG. 10B is a schematic drawing of a top view of a longitudinal section of the anchor engagement element taken at line 10b-10b of FIG. 10A.
“FIG. 11 is a schematic top exploded view of an embodiment of an anchor deployment apparatus.
“FIG. 12 is a schematic perspective view of an embodiment of an anchor engagement element with a longitudinal section taken through line 12-12 of FIG. 11.
“FIGS. 13A-B are schematic sectional views of embodiments of portions of an alignment element with sections taken through lines 13a-13a and 13b-13b of FIG. 11, respectively.
“FIG. 14 is a schematic top view of an embodiment of anchor deployment apparatus.
“FIGS. 15A-B are schematic sectional views of embodiments of portions of an anchor deployment apparatus with sections taken through lines 15a-15a and 15b-15b of FIG. 14, respectively.
“FIGS. 16A-B are schematic sectional views of alternative embodiments of portions of an anchor deployment apparatus with sections taken through lines 15a-15a and 15b-15b of FIG. 14, respectively.
“FIG. 17 is a schematic top view of an embodiment of anchor deployment apparatus.
“FIG. 18 is a schematic top view of an embodiment of a anchor engagement element of the anchor deployment apparatus depicted in FIG. 18.
“FIG. 19 is a schematic sectional view of an embodiment of the anchor engagement element depicted in FIG. 18, taken through line 19-19.
“FIG. 20 is a schematic drawing of a top view of components of a kit.
“FIGS. 21A-C are schematic drawings of top views of a system including an anchor, an insertion element, and an anchor receiving element.
“FIG. 22 is a cross section of an anchor disposed about an insertion element taken along line 22-22 of FIG. 21. FIGS. 23A-B are schematic top views of an embodiment of an insertion element. FIGS. 24A-B are schematic top views of another embodiment of an insertion element.
“The drawings are not necessarily to scale. Like numbers used in the figures refer to like components, steps and the like. However, it will be understood that the use of a number to refer to a component in a given figure is not intended to limit the component in another figure labeled with the same number. In addition, the use of different numbers to refer to components is not intended to indicate that the different numbered components cannot be the same or similar.”
URL and more information on this patent application, see: Behymer, Bruce A.; Silverberg, Jacob W.; Klardie, Michael R.; Kern, Michael J. Anchor Deployment Apparatus. Filed December 27, 2013 and posted July 3, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1823&p=37&f=G&l=50&d=PG01&S1=20140626.PD.&OS=PD/20140626&RS=PD/20140626
Keywords for this news article include: Therapy, Medtronic Inc..
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