U.S. patent application number 12/038930 was filed with the patent office on 2008-08-28 for implantable medical device system with fixation member.
Invention is credited to Jean J.G. Rutten, Karel F.A.A. Smits.
Application Number | 20080208248 12/038930 |
Document ID | / |
Family ID | 39709229 |
Filed Date | 2008-08-28 |
United States Patent
Application |
20080208248 |
Kind Code |
A1 |
Rutten; Jean J.G. ; et
al. |
August 28, 2008 |
IMPLANTABLE MEDICAL DEVICE SYSTEM WITH FIXATION MEMBER
Abstract
A fixation device for a subcutaneous implantable medical device
includes a deformable tip portion that reduces in width when
coupled with a fixation tool such that implantation of the
implantable medical device through tissue is facilitated. Upon
release from the fixation tool, the fixation device returns to its
initial shape and stably secures the position of the implantable
medical device.
Inventors: |
Rutten; Jean J.G.;
(Bocholtz, NL) ; Smits; Karel F.A.A.;
(Munstergeleen, NL) |
Correspondence
Address: |
MEDTRONIC, INC.
710 MEDTRONIC PARKWAY NE
MINNEAPOLIS
MN
55432-9924
US
|
Family ID: |
39709229 |
Appl. No.: |
12/038930 |
Filed: |
February 28, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60892048 |
Feb 28, 2007 |
|
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Current U.S.
Class: |
606/205 |
Current CPC
Class: |
A61N 1/3956 20130101;
A61M 25/04 20130101; A61N 1/0504 20130101 |
Class at
Publication: |
606/205 |
International
Class: |
A61B 17/00 20060101
A61B017/00 |
Claims
1. A fixation member for use with an implantable medical device for
stabilizing the position of the implantable medical device at an
implant site, the fixation member comprising: a first side, a
second side, a distal tip formed by the convergence of the first
side and the second side, and a proximal base extending between the
first side and the second side.
2. The fixation member of claim 1 wherein the first side and the
second side form an aperture therebetween adapted to receive a
delivery tool used for advancing the medical device to the implant
site.
3. The fixation member of claim 1 wherein the base protrudes toward
the distal tip.
4. The fixation member of claim 1 further including a receptacle
extending proximally from the proximal base, the receptacle adapted
to be coupled to the medical device.
5. The fixation member of claim 1 wherein the first side, second
side, distal tip and proximal base have an approximately flat
profile.
6. The fixation member of claim 1 wherein the base is arcuate.
7. The fixation member of claim 1 wherein the first side and the
second side comprise at least one of an arcuate segment and a
straight segment.
8. The fixation member of claim 1 wherein the first side straight
segment and the second side straight segment are parallel.
9. The fixation member of claim 1 wherein the base has a stiffness
greater than a stiffness of each of the first side and the second
side.
10. The fixation member of claim 1 further comprising a support
structure extending between the base and at least one of the first
side and the second side.
11. The fixation member of claim 1 wherein a cross-section of each
of the first side and the second side is approximately
quadrilateral.
12. The fixation member of claim 1 wherein the base includes at
least one barb for promoting fixation of the fixation member at an
implant site.
13. The fixation member of claim 1 wherein the base is adapted to
wrap around a delivery tool such that the fixation member becomes
approximately isodiametric with the delivery tool.
14. The fixation member of claim 1 wherein a distance between the
first side and the second side is reduced upon stretching of the
fixation member in response to a proximally applied tension.
15. The fixation member of claim 14 wherein the distance between
the first side and the second side is initially increased before
being reduced in response to a proximally applied tension.
16. The fixation member of claim 1 is formed from silicone
rubber.
17. The fixation member of claim 1 further comprising a material
for promoting tissue adhesion.
18. The fixation member of claim 1 further comprising a port in
communication with a delivery lumen of the medical device.
19. The fixation member of claim 1 further comprising a break point
along which the fixation member splits in response to a proximally
applied tension.
20. The fixation member of claim 1 further comprising a
radio-opaque material.
21. The fixation member of claim 1 wherein the distal tip includes
a rigid material.
Description
RELATED APPLICATIONS
[0001] This application is related to, and claims the benefit of,
provisionally-filed U.S. Patent Application Ser. No. 60/892,048,
filed Feb. 28, 2007, and entitled "Implantable Medical Device
System with Fixation Member", which is incorporated herein by
reference in its entirety.
TECHNICAL FIELD
[0002] The invention relates generally to implantable medical
devices and, in particular, to a fixation member for an implantable
medical device.
BACKGROUND
[0003] Implantable medical devices are often provided with a
fixation member for maintaining the device at a desired location
within a patient's body. For example, elongated medical devices
such as catheters and electrical leads may include a fixation
member at or near the distal end of the device for maintaining the
position of the device at a targeted implant site. Fixation members
can include active and/or passive fixation members, for example in
the form of hooks, barbs, helices or tines.
[0004] Implantable medical leads are used for deploying electrodes
or physiological sensors to a targeted implant site. The lead
carries electrical conductors allowing electrical connection of the
deployed electrodes or sensors to a medical device such as a
pacemaker, implantable cardioverter defibrillator, neurostimulator,
or physiological monitor. Fluid delivery catheters may be used for
delivering a fluid to a targeted body site to achieve an optimal
effect. Fluid delivery catheters are generally coupled to a pump or
other fluid dispensing device. A fluid delivered to a targeted site
may be a dye used in a monitoring or diagnostic procedure, or a
pharmaceutical agent or genetic or biological material for
achieving a therapeutic effect. Reliable monitoring and/or therapy
delivery by an implanted medical device is typically dependent on
proper and stable positioning of the medical device. As such, many
medical devices require a fixation member that reliably maintains
the position of the device at a targeted body site without causing
significant tissue trauma. In some cases, a delivery tool is needed
for deploying the device to the targeted site.
[0005] Depending upon the nature of the medical device, fixation
may be permanent or temporary. Thus, the fixation mechanisms is
selected accordingly. For example, a cardiac pacing/defibrillation
lead is implanted for long term use and the fixation mechanism may
be rather robust, such as a helical member screwed into tissue.
Conversely, many catheters are inserted on a temporary basis. Thus,
while important to secure these device in place as needed; it is
also important to be able to remove and retract these devices from
the human body without adverse consequence.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] Aspects and features of the present invention will be
appreciated as the same becomes better understood by reference to
the following detailed description of the embodiments of the
invention when considered in connection with the accompanying
drawings, wherein:
[0007] FIG. 1 depicts a patient implanted with a subcutaneous
implantable cardioverter defibrillator.
[0008] FIG. 2 is a plan view of the lead shown in FIG. 1.
[0009] FIG. 3 is a plan view of a fluid delivery device including a
fixation member.
[0010] FIGS. 4A through 4C are plan views of various embodiments of
a fixation member for use with an implantable medical device.
[0011] FIG. 5A is a side view of the fixation member shown in FIG.
4A.
[0012] FIG. 5B is a plan view of a fixation member including
material for promoting tissue ingrowth.
[0013] FIG. 6A is a cross-sectional view of a fixation member
side.
[0014] FIG. 6B is a cross-sectional view of a fixation member side
in an alternative embodiment.
[0015] FIGS. 7 and 8 are plan views of alternative embodiments of a
fixation member for use with a medical device.
[0016] FIGS. 9 and 10 are perspective views of alternative
embodiments of a fixation member.
[0017] FIG. 11 is a top plan view of a medical device having a
fixation member.
[0018] FIG. 12 is a side plan view of the medical device shown in
FIG. 11.
[0019] FIG. 13 is a side plan view and FIG. 14 is a top plan view
of a medical device delivery tool.
[0020] FIGS. 15 and 16 are top plan views of a medical device
including a fixation member being mounted on the delivery tool
shown in FIGS. 13 and 14.
[0021] FIG. 17 is a top plan view of a distal portion of the
fixation member mounted on the delivery tool shown in FIG. 16.
[0022] FIGS. 18 and 19 are side and top views, respectively, of a
delivery tool distal portion having an alternative release
mechanism used for releasing a fixation member from the delivery
tool.
[0023] FIGS. 20 and 21 are side and top views, respectively, of the
distal portion of the delivery tool shown in FIGS. 18 and 19
wherein the release mechanism has been actuated to release the
fixation member from the delivery tool.
[0024] FIG. 22 is a side sectional view of an alternative
embodiment of a delivery tool release mechanism.
[0025] FIGS. 23 and 24 are side and top views, respectively, of an
alternative embodiment of a delivery tool.
DETAILED DESCRIPTION
[0026] In the following description, references are made to
illustrative embodiments for carrying out the invention. It is
understood that other embodiments may be utilized without departing
from the scope of the invention. For purposes of clarity, the same
reference numbers are used in the drawings to identify similar
elements. Unless otherwise noted, drawings referred to herein are
not shown to scale.
[0027] Embodiments of the invention include implantable medical
device systems wherein an implantable medical device is provided
with a fixation member for maintaining a stable implant position.
Such systems will typically include an elongated medical device,
such as an electrical lead or a fluid delivery catheter, that is
tunneled or advanced to a targeted implant site for monitoring
physiological signals and/or delivering a therapy. Embodiments of a
medical device system include a delivery tool used to deploy the
elongated medical device to the target site. Exemplary applications
of various embodiments include implantable pacemaker systems,
implantable cardioverter defibrillator systems, implantable
neurostimulator systems, implantable drug delivery systems,
implantable physiological monitoring systems or any other
implantable medical device system relying on stable fixation of a
medical device at an implant site. Implant sites may be
subcutaneous sites, sub- or intramuscular sites, within the brain
cavity, thoracic cavity, pleural cavity, within an organ wall,
within a lumen of a vessel or organ, or any other internal body
site.
[0028] FIG. 1 depicts a patient 6 implanted with a subcutaneous
implantable cardioverter defibrillator (SubQ ICD) 4. SubQ ICD 4 is
coupled to an implantable medical lead 10. Lead 10 includes an
elongated lead body 12 including a coil electrode 20 and lead 10 is
adapted for subcutaneous implantation. Lead 10 includes a fixation
member 22 for maintaining the position of coil electrode 20 at a
desired body site. In FIG. 1, SubQ ICD 4 is implanted in an
anterior position relative to the patient's heart 8. The housing 9
of SubQ ICD 4 is used in conjunction with subcutaneous coil
electrode 20 for delivering high-voltage shocks to the patient's
heart. SubQ ICD 4 includes electrodes 7 that are used for sensing
electrical signals from the heart such as, for example, to detect
ventricular arrhythmias that need to be shocked. Lead body 12 is
passed through a subcutaneous tunnel disposed laterally along the
patient's chest wall, toward the patient's spine 5 to position coil
electrode 20 posteriorly, relative to the heart 8. Fixation member
22 maintains the position of coil electrode 20 in the posterior
position such that appropriate shocking vectors can be established
between SubQ ICD 4 and coil electrode 20 relative to heart 8 to
enable successful cardioversion/defibrillation of heart 8. SubQ ICD
4 and associated lead 10 illustrate one implantable medical device
system in which embodiments of the present invention may be
implemented.
[0029] FIG. 2 is a plan view of the lead 10 shown in FIG. 1. Lead
10 includes elongated lead body 12 extending between a proximal end
14 and a distal end 16. Lead body 12 is typically fabricated from a
flexible insulative material including one or more lumens for
carrying conductors (not shown) extending between proximal end 14
and distal end 16. A connector assembly 18 at proximal end 14
facilitates electrical connection of lead 10 to an associated
medical device, such as SubQ ICD 4 shown in FIG. 1. One or more
electrodes and/or physiological sensors are positioned along lead
body 12, at or near distal lead body end 16. In the embodiment
shown in FIG. 2, a coil electrode 20 used in delivering high energy
shock pulses for cardioverting or defibrillating the heart is
positioned along lead body 12 near distal end 16.
[0030] In other embodiments, lead 10 may be adapted for use with
other implantable medical devices such as pacemakers,
neurostimulators, physiological monitors or the like. As such, it
is recognized that lead 10 may be adapted for carrying additional
electrodes and/or other physiological sensors. Lead 10 may include
additional coil electrodes, and/or lead 10 may include one or more
ring electrodes used for sensing and/or stimulation. Other sensors
carried by lead 10 may include temperature sensors, motion sensors,
pressure sensors, electrodes for measuring impedance, oxygen
sensors, etc.
[0031] A fixation member 22 is coupled to the lead body distal end
16 for maintaining a stable position of lead body distal end 16
upon deployment of lead 10 to an implant site. Fixation member 22
includes a first side 24 and a second side 26. First side 24 and
second side 26 converge to form a distal tip 28. A proximal base 30
extends between first side 24 and second side 26 along a proximal
end 32 of fixation member 22. Fixation member 22 is generally
tapered such that the distance 40 between first side 24 and second
side 26 near base 30 is greater than the distance 42 between first
side 24 and second side 26 near distal tip 28. Fixation member 22
is shown to be generally triangular in shape having substantially
straight first and second sides 24 and 26, which converge to form
distal tip 28.
[0032] First side 24 and second side 26 form an aperture 34
therebetween for receiving a delivery tool used for tunneling and
advancing lead 10 to a targeted implant site. Fixation member 22
further includes a receptacle 36 for receiving lead body distal end
16 to enable fixation member 22 to be coupled to lead body distal
end 16.
[0033] FIG. 3 is a plan view of a fluid delivery device including a
fixation member. Fluid delivery device 50 is embodied as a catheter
including an elongated body 52 forming a lumen 54 extending between
a proximal end 56 and distal end 58 of body 52. A fitting 60 is
provided at proximal end 56 to enable coupling of device 50 to a
fluid pump, syringe or other fluid dispensing device. Fixation
member 62 is provided at catheter body distal end 58 for
maintaining the position of distal end 58 at a desired body
site.
[0034] Fixation member 62 includes a first side 64 and a second
side 66, which converge to form a distal tip 68, forming an
aperture 74 therebetween for receiving a delivery tool adapted for
advancing fluid delivery device 50 to a desired body site. Fixation
member 62 is shown to be generally triangular in shape and includes
a proximal base 70 extending between first side 64 and second side
66 at fixation member proximal end 72. Fixation member 62 further
includes a receptacle 76 for receiving catheter body distal end 58
to facilitate coupling of fixation member 62 to catheter body 52.
Receptacle 76 may include a lumen 78 in communication with lumen 54
of catheter body 52 and a port 80 adapted to dispense a fluid
flowing through lumens 54 and 78 to a targeted body site. Other
apertures or ports may be provided along catheter body 52 in fluid
communication with lumen 54 for dispensing a fluid. Fluid delivery
device 50 may be used for delivering dyes, pharmaceutical
solutions, or biological or genetic material.
[0035] Although not shown, it is recognized that fluid delivery
device 50 may include electrodes or other sensors positioned along
catheter body 52 and coupled to insulated conductors extending
within catheter body 52. Likewise, it is recognized that the lead
10 shown in FIG. 2 could include a delivery lumen in communication
with delivery port for delivering fluids or other medical
devices.
[0036] FIG. 4A is a plan view of a fixation member 100 for use with
an implantable medical device. Fixation member 100 is coupled to
the distal end 120 of an elongated medical device 124 to provide
stable fixation of the medical device distal end 120 at a desired
body location. Receptacle 112 of fixation member 100 includes a
bore 114 adapted to receive distal medical device end 120. In one
embodiment, distal end 120 is press fit within bore 114 and may be
secured with an adhesive, such as silicone medical adhesive, to
fixedly attach distal end 120 within receptacle 112. In other
embodiments, bore 114 and medical device distal end 120 are
provided with interlocking members or other features for providing
a stable mechanical coupling of bore 114 with medical device distal
end 120. In the embodiment shown in FIG. 4A, bore 114 includes a
groove 116 adapted to mate with a flange 122 extending radially
from medical device distal end 120. Flange 122 and groove 116 are
adapted to allow medical device distal end 120 to be advanced into
bore 114 until flange 122 and groove 116 interlock and thereafter
act to retain medical device distal end 120 within receptacle 112.
Coupling between receptacle 112 and medical device distal end 120
may be further stabilized by using an adhesive, such as a silicone
medical adhesive. It is recognized that other interlocking or
mating structures may be provided to promote a stable mechanical
junction between fixation member 100 and medical device distal end
120. In alternative embodiments, fixation member 100 may be molded
onto medical device distal end 120.
[0037] Fixation member 100 is formed from a resilient, biostable,
polymeric material, such as a medical grade silicone rubber. In one
embodiment, fixation member is molded from silicone rubber having a
70 durometer Shore A hardness. Appropriate silicone rubber
materials are available from NuSil Technology, Carpinteria, Calif.
As will be further described below, fixation member 100 is mounted
on a delivery tool which is used to advance fixation member 100 to
a desired body site. Fixation member 100 is configured to withstand
tunneling forces required during an implant procedure and
stretching that may be applied to mount fixation member on the
delivery tool. Fixation member 100 is further configured to have a
bending flexibility that allows it to wrap around and narrowly
conform to the delivery tool during advancement to an implant site.
However, the bending flexibility is balanced with a stiffness and
resiliency needed to cause fixation member 100 to resume its
previous shape upon release from the delivery tool and to retain
that shape during body movement. Various aspects of fixation member
100 that allow member 100 to be designed with a desired tensile
strength, stiffness and bending flexibility for optimal performance
will be further described herein.
[0038] Fixation member 100 includes a delivery tool aperture 106
formed by first side 102 and second side 104. Distal tip 105 is
shown to be a generally rounded, atraumatic tip. However, it is
recognized that in alternative embodiments, tip 105 may be provided
as a sharper or pointed tip to facilitate tunneling through tissue
to an implant site. In some embodiments tip 105 may be formed
having a greater stiffness to withstand tunneling forces. Once
positioned at a targeted site, the width of fixation member 100
along proximal base 108 inhibits retraction or dislodgment of
fixation member 100 away from the target site.
[0039] Base 108 may be provided with barbs 117 and 118 extending in
a generally proximal direction to inhibit retraction of fixation
member 100 from a desired implant site. Barbs 117 and 118 also
inhibit retraction or dislodgment of fixation member 100 and act to
prevent curling or flexing of fixation member, thereby maintaining
fixation member in a generally flat configuration.
[0040] Base 108 is shown as an arcuate segment, curving slightly
inward toward distal tip 105. Body motion, such as movement
associated with respiration or activity, may cause tugging on
elongated body 120. Proximal tension applied to fixation member
100, e.g. tugging on elongated body 120 that may occur with body
motion, will initially cause the proximal end 140 of fixation
member to widen from a normal width 142 to an extended width 144.
Widening of proximal end 140 is caused by the straightening of
arcuate base 108, as indicated by dashed line 115, and the
resultant outward flexing of barbs 117 and 118 as proximal tension
is applied by elongated body 120. A distance 146 between first side
102 and second side 104 in a relaxed state initially increases to a
greater distance 148 in response to proximal tension. This initial
widening of fixation member 100 in response to applied tension
inhibits retraction or dislodgment of member 100 from the implant
site.
[0041] Application of greater proximal tension causes fixation
member 100 to elongate and narrow. As such, if retraction of
fixation member 100 is required, greater proximal tension may be
used to retract fixation member 100. In one embodiment, fixation
member 100 is designed to withstand a retraction force of
approximately 2 Newtons prior to becoming dislodged from a
subcutaneous implant location.
[0042] Fixation member 100 includes support beams 110 extending
between first side 102 and base 108 and between second side 104 and
base 108. Support beams 110 serve to support first and second sides
102 and 104 and base 108 in a generally flat profile after
implantation, i.e. beams 110 act to reduce bending or flexing of
fixation member 100 after implantation.
[0043] It is recognized that a fixation member may be provided with
alternative base configurations in various embodiments of the
invention. In FIG. 4B, a base 108' of fixation member 100' is shown
having an inverted "V" shape. Base 108' extends inward toward
distal tip 105'. In this configuration, proximal tension applied to
base 108' will cause initial widening of fixation member 100' as
base 108' is straightened in response to the proximal tension.
[0044] In FIG. 4C, a base 108'' of fixation member 100'' is shown
having a "V" shape. Proximal tension applied to base 108'' will
cause narrowing of fixation member 100'' as it is stretched over a
delivery tool for advancement to an implant site. Barbs 117'' and
118'' may be provided which flex slightly outward in response to
proximal tension causing an initial widening of fixation member
100''.
[0045] FIG. 5A is a side view of fixation member 100 shown in FIG.
4A. Fixation member 100 has a generally flat profile. As described
above, fixation member 100 includes first side 102 (not visible in
the side view of FIG. 5), second side 104, distal tip 105, proximal
base 108 having barb 118 and a receptacle 112 forming a bore 114
for receiving a medical device distal end. The flat profile allows
stable fixation of a medical device in a subcutaneous position
while minimizing patient discomfort. To reduce bending or flexing
of first side 102, second side 104 and base 108 after implantation,
base 108 is provided with a greater thickness 130 than the
thickness 132 of sides 102 and 104. A greater stiffness of base
108, corresponding to its greater thickness, helps to maintain the
flat, generally triangular shape of fixation member 100. As will be
described in greater detail below, the greater stiffness of base
108 also supports expansion of fixation member from a stretched and
rolled or wrapped configuration when mounted on a delivery tool to
an expanded, generally flat configuration upon release from the
delivery tool. Relatively thinner sides 102 and 104 facilitate
easier mounting and releasing from the delivery tool and allow for
an overall smaller size of fixation member 100 and an associated
delivery tool. A smaller sized fixation member and smaller delivery
tool will generally cause less tissue trauma. The thickness and
stiffness of base 108 relative to sides 102 and 104 may be designed
according to a particular application for achieving desired tensile
strength and bending stiffness of fixation member 100.
[0046] Fixation member 100 is shown having material 134 coupled
along side 104. Material 134 is provided to promote tissue
adhesions to further promote stable fixation of member 100.
Material 134 may be provided as a mesh or porous material that
encourages tissue ingrowth. In one embodiment, material 134 is
provided as polyethylene terephthalate fiber material (Dacron.RTM.,
available from DuPont).
[0047] FIG. 5B is a plan view of a fixation member including
additional material for promoting tissue ingrowth. In addition to,
or alternatively to, providing a material covering a portion of the
fixation member for promoting tissue adhesion, material 136 may be
provided extending between any of first side 137, second side 138,
base 139 and/or support beams 141 of a fixation member 135.
Material 136 increases the stiffness of fixation member 135 which
will improve the stable fixation of member 135 at an implant site
acutely. By promoting tissue ingrowth, material 136 improves
chronic stability of the fixation member at the implant site.
[0048] FIG. 6A is a cross-section of fixation member first side 102
along view A-A shown in FIG. 4A. The cross-sectional shape of sides
102 and 104 and base 108 may be generally quadrilateral as shown,
for example, in FIG. 6A. In particular, side 102 is shown having a
rectangular cross-section with squared corners 154. Squared corners
154 are expected to reduce slippage of fixation member 100 after
implantation in comparison to rounded corners. Moreover, providing
first and second sides 102 and 104 with a quadrilateral
cross-section allows fixation member 100 to be designed with a
desired balance between tensile strength and bending stiffness. The
balance between tensile strength and bending stiffness is
controlled by adjusting the thickness 150 and the width 152 of side
102 (and second side 104 and base 108). A rectangular cross-section
allows better control over the balance of tensile strength and
flexibility than a circular cross-section. For example the
flexibility of side 102 can be increased by reducing thickness 150
while the tensile strength can be increased by increasing width
152. However, it is recognized that the cross-sectional shape of
sides 102 and 104 as well as base 108 may include one or more
rounded corners. For example, side 102' is shown to be generally
D-shaped in FIG. 6B. In still other embodiments, sides 102 and 104
and base 108 may be generally circular or oval in
cross-section.
[0049] It is contemplated that numerous configurations for a
fixation member having first and second sides converging to form a
distal tip and forming a delivery tool aperture there between may
be conceived. In alternative embodiments the first and second sides
may include curved (concave or convex) and parallel segments, or
any combination of thereof. For example, as shown in FIG. 7,
fixation member 200 includes sides 202 and 204 each having
generally straight, parallel segments 206 and 210, respectively,
and generally curved segments 208 and 212, respectively. Curved
segments 208 and 212 converge to form distal tip 214.
[0050] In some embodiments distal tip 214 may include a rigid
plastic or metal material. Distal tip 214 is shown in FIG. 7 having
a rigid pointed cap 216 for facilitating tunneling of fixation
member 200 to an implant site. Rigid cap 216 may be formed of a
relatively stiffer silicone rubber, a rigid polymer, or a metal. In
some embodiments, a rigid material is coupled to first and second
sides 202 and 204 as they converge to form a rigid distal tip.
[0051] Support beams extending between the first and second sides
and the proximal base may also be provided in a variety of
configurations. In FIG. 7, a "Y" shaped support beam 222 extends
between each of sides 202 and 204 and base 218. An aperture 230 is
formed by sides 202 and 204 and support beam 222 for receiving a
delivery tool.
[0052] The shape and size of barbs provided on the proximal base
may also vary. Base 218 is provided with rounded barbs 220
extending in a generally proximal direction.
[0053] In FIG. 8, fixation member 250 includes convex first and
second sides 252 and 254 which converge to form distal tip 256. A
support beam 262 extends between distal tip 256 and base 258. Base
258 includes pointed barbs 260 extending in a generally proximal
direction for inhibiting retraction of fixation member 250.
Apertures 264 and 265 are formed by support beam 262 and side 252
and side 254, respectively. One or both apertures 264 and 265 may
be adapted to receive a delivery tool.
[0054] Fixation member 250 may be provided as a splittable member
having one or more break points indicated by lines 272 and 270.
Fixation member 250 is designed to have a tensile strength that
withstands the pushing forces needed to tunnel fixation member 250
to a desired implant site when mounted on a delivery tool. In some
situations, retraction of the medical device and fixation member
250 is required. In order to facilitate retraction of fixation
member 250, fixation member 250 is provided with a relatively
weaker break point 272 or 270. Upon applying a retraction force
exceeding the tensile strength of fixation member 250 across the
break point 272 or 270, fixation member 250 will split along the
break point 270 or 272. A break point 272 provided along distal tip
256, or along either side 252 and 254, will allow fixation member
250 to split, then elongate and collapse inward as it is retracted
through a tissue tunnel.
[0055] Alternatively, a break point 270 may be provided along
receptacle 274, at a point distal to the coupling between fixation
member 256 and a medical device. Break point 270 would allow the
receptacle 274 to split from the remaining portion of fixation
member 250. Upon retraction of the medical device, fixation member
250 would be left behind at the implant site. Fixation member 250
could then be removed from a subcutaneous position via a small
incision if desired. Break points 270 and 272 may be formed, for
example, as splittable seams, perforated lines, or as a narrowed
outer diameter to create a weakened tensile strength across the
break point relative to the remaining portions of fixation member
250.
[0056] In some embodiments, fixation member 250 is provided with
radio-opaque markers 280 to allow visualization of fixation member
250 after implantation. Radio-opaque markers 280 may be used to
verify the location of fixation member 250 during the implant
procedure. If fixation member 250 is provide with a break point 272
along receptacle 274 and is left behind after retracting the
associated medical device, radio-opaque markers 280 may be used to
locate fixation member 250 for surgical removal.
[0057] Depending on the specific application, fixation member 100
may alternatively be formed having a more three-dimensional
geometry rather than the substantially planar, low-profile
geometries described above. FIG. 9 illustrates a fixation member
300 having a generally pyramidal shape, including multiple sides
302, 304, 306 and 308 converging to form distal tip 310. Fixation
member 300 includes multiple base segments 312, 314, 316, 318 and
320 extending between respective pairs of sides 302, 304, 306 and
308. Sides 304 and 306 form an aperture 322 for receiving a
delivery tool. Sides 304 and 306 are not joined by a base segment
to allow more room for a delivery tool to be inserted into aperture
322. A receptacle 324 extends proximally from the intersection of
base segments 316 and 318 for receiving a medical device distal
end.
[0058] FIG. 10 is a perspective view of an alternative embodiment
of a fixation member 350. Fixation member 350 is formed having
first and second sides 352 and 354 which converge to from distal
tip 356. Sides 352 and 354 form a portion of a hemisphere and are
narrower near distal tip 356 and wider near proximal base 358.
Sides 352 and 354 form an aperture 362 there between for receiving
a delivery tool. A receptacle 360 extends proximally from base 358
for receiving a medical device distal end to allow coupling of
fixation member 350 to the medical device. It is recognized that a
variety of geometries for a fixation member may be conceived,
including generally conical, pyramidal, or hemispherical
shapes.
[0059] FIG. 11 is a top plan view of a medical device 400 having a
fixation member 410. Fixation members provided according to various
embodiments of the invention will generally be coupled to a distal
end of an elongated medical device. However, according to an
embodiment of the present invention, a fixation member 410 may be
coupled at other points along an elongated body, or along other
features of a medical device. For example, as illustrated in FIG.
11, a medical device 400 includes an elongated body 402 having a
distal end 404. Fixation member 410 includes a first side 412 and
second side 414, which converge to form a distal tip 420, and form
a delivery tool aperture 422 there between. A proximal base 418
extends between first and second sides 412 and 414. A receptacle
416 extends proximally from base 418 and is coupled to medical
device body 402 at a location proximal to distal end 404.
[0060] FIG. 12 is a side plan view of the medical device 400 shown
in FIG. 11 having fixation member 410. Receptacle 416 is offset
from the plane of base 418 and second side 414 such that fixation
member 410 can be coupled along elongated body 402, proximal to
distal end 404. Fixation member 410 is offset from and extends
substantially parallel to elongated body 402. It is recognized that
fixation member 410 may alternatively be offset from and oriented
at other angles with respect to elongated body 402.
[0061] The various embodiments of a fixation member described
herein include an aperture for receiving a delivery tool. FIG. 13
is a side plan view and FIG. 14 is a top plan view of a medical
device delivery tool 500. Delivery tool 500 may be used for
deploying a medical device having a fixation member as described
above. Delivery tool 500 includes a shaft 502 which may be provided
as a malleable shaft formed of stainless steel. Shaft 502 extends
between a proximal end 504 and a distal end 506. A handle 510 is
provided at proximal end 504 for maneuvering shaft 502 during an
implant procedure. A delivery tool head 520 is provided at shaft
distal end 506 for carrying a medical device during an implant
procedure. In particular, delivery tool head 520 is adapted for
carrying a fixation member coupled to an elongated medical
device.
[0062] Delivery tool head 520 includes a distal tunneling tip 522
that is generally pointed for facilitating tunneling of tool 500
through body tissues to an implant site. Tunneling tip 522 may be
rounded to reduce tissue trauma or more pointed to cut more easily
through tissues thereby reducing the pushing force needed to
advance delivery tool 500.
[0063] Delivery tool head 520 includes a mounting portion 525 for
carrying a fixation member of a medical device. Mounting portion
525 is provided with a groove 524 extending along each side of
mounting portion 525 and around tunneling tip 522. Groove 524
receives a medical device fixation member as will be further
described below. Delivery tool head 520 includes a narrowed neck
portion 527 extending proximally from mounting portion 525.
Narrowed neck portion 527 allows a medical device fixation member
to wrap around delivery tool head 520 such that the fixation member
and head 520 become approximately isodiametric during advancement
to an implant site.
[0064] Delivery tool head 520 further includes restraint 526 for
retaining a portion of the medical device fixation member carried
by tool head 520. Restraint 526 is designed to releasably hold a
portion of the medical device fixation member. As will be further
described below, a fixation member is stretched over mounting
portion 525 with the fixation member proximal base held by
restraint 526. Restraint 526 is designed to function as both a
retaining and release mechanism. Proximal handle 510 includes a
mechanical switch 512 for controlling restraint 526. In one
embodiment, activation of switch 512 from a first position 514 (as
shown) to a second position 516 (indicated by dashed line) actuates
restraint 526 from a retaining position 540 (as shown) to a release
position 542 (indicated by dashed line). Activation of switch 512
causes a rotation of restraint 526 via a pull wire (not shown). The
rotation of restraint 526 pushes the fixation member proximal base
up and away from delivery tool head 520. In alternative
embodiments, delivery tool head 520 may include separate restraint
and release mechanisms.
[0065] Switch 512 is a bistable switch in some embodiments in which
a first stable position 514 corresponds to retaining a fixation
member on delivery tool head 520 and a second stable position 516
corresponds to releasing the fixation member from the delivery tool
head. Switch 512 may alternatively be provided as a monostable
switch having a stable position corresponding to retaining the
fixation member and provides tactile or audible feedback
corresponding to the release of the fixation member from the
delivery tool head. The circumferential position of switch 512 on
handle 510 can also serve as an indicator of the orientation of
delivery tool head 520.
[0066] Shaft 502 may be formed with a contoured outer surface, e.g.
a concave surface 530, for accommodating an elongated body of the
medical device. The length and cross-sectional contour of shaft 502
may vary depending on the particular application. Shaft 502 further
includes one or more flanges 532 and 534 for maintaining the
position of the elongated body along shaft 502 and inhibiting
rotation or twisting of the elongated body of a medical device
extending along shaft 502. Flanges 532 and 534 do not limit
longitudinal movement (along the tool axis) of the elongated body
relative to the shaft 502. As such, flanges 532 and 534 do not form
a tight fit with the elongated body and provide a space
therebetween so as to readily release the elongated body from tool
500 upon release of the fixation member from delivery tool head
520. However, it is contemplated that in some embodiments, flanges
532 and 534 may retain the elongated body for inhibiting
longitudinal movement (along the tool axis) of the elongated body
relative to shaft 502 as well as rotational movement. Shaft 502
further includes a stop surface 528 for interfacing with a surface
of the medical device to prevent over-stretching of the fixation
member carried by delivery tool head 520 as will be further
described below.
[0067] FIGS. 15 and 16 are top plan views of a medical device 550
including a fixation member 560 being mounted on the delivery tool
500 shown in FIGS. 13 and 14. Delivery tool shaft 502 is shown in
FIG. 15 having a pre-shaped curve or bend 518. Shaft 502 may be
provided having one or more pre-shaped bends or curves to
facilitate advancement of delivery tool 500 to an implant site. The
particular configuration of shaft 502 may be selected according to
the intended application.
[0068] In FIG. 15, fixation member 560 is shown in an unstretched,
normal state. Fixation member 560 includes a first side 562 and a
second side 564 which converge to form a distal tip 566. First side
562 and second side 564 form a delivery tool aperture 572 for
receiving delivery tool head 520. Fixation member 560 includes
proximal base 568 extending between first side 562 and second side
564. Base 568 is provided with barbs 580. A receptacle 570 extends
proximally from base 568. A distal end 554 of medical device
elongated body 552 is coupled to receptacle 570.
[0069] Delivery tool head 520 is inserted through fixation member
aperture 572, and fixation member distal tip 566 is positioned in
the groove 524 (shown in FIG. 13) of mounting portion 525. Medical
device elongated body 552 extends along delivery tool shaft 502,
resting along concave surface 530. Flanges 532 and 534 inhibit
rotation or twisting of elongated body 552 relative to shaft
502.
[0070] In FIG. 16, fixation member 560 is shown in a stretched
state, positioned on delivery tool head 520 for advancement to an
implant site. Base 568 is stretched proximally by pulling medical
device 550 back toward proximal end 504 of shaft 502 with distal
tip 566 positioned within groove 524 of mounting portion 525 and
held in the stretched position by restraint 526. In the stretched
position, fixation member 560 becomes elongated and narrower to
facilitate tunneling through tissue to an implant site. A distance
590 (FIG. 15) between first and second sides 562 and 564 along base
568 in relaxed state is reduced to a shorter distance 592 (FIG. 16)
upon stretching fixation member 560 over delivery tool head 520.
First and second sides 562 and 564 reside in groove 524 of mounting
portion 525. Fixation member distal tip 566 and sides 562 and 564
protrude slightly from groove 524 of mounting portion 525. It is
recognized that in some embodiments, fixation member distal tip 566
and first and second sides 562 and 564 may reside entirely within
groove 524 of mounting portion 525. Groove 524 is sized to form a
snug fit with fixation member 560 to prevent fixation member 560
from falling off delivery tool head 520 and to prevent tissue from
becoming pinched between delivery tool head 520 and fixation member
560 during advancement to an implant site. Fixation member distal
tip 566 and sides 562 and 564 are protected within groove 524
during advancement to a tissue site.
[0071] Fixation member 560, being stretched over delivery tool
head, becomes narrower to facilitate tunneling to an implant site.
Restraint 526 maintains the tension of fixation member 560 to keep
member 560 from falling off the delivery tool head. In one
embodiment, fixation member 560 is stretched to approximately 120%
to 200% of its normal length when mounted on delivery tool head
520. In the stretched position, a proximal face 574 of receptacle
570 interfaces with stop surface 528 to prevent overstretching of
fixation member 560. In some embodiments, restraint 526 is optional
and stretching of fixation member 560 may be accomplished by an
implanting clinician maintaining tension on the proximal end of the
elongated medical device 550. The stop surface 528 prevents the
clinician from overstretching fixation member 560.
[0072] FIG. 17 is a top plan view of a distal portion of the
fixation member 560 mounted on the delivery tool 500 shown in FIG.
16. As the tunneling tip 522 of delivery tool 500 is tunneled
through tissue to a desired implant site, sides 562 and 564 of
fixation member 560 fold in around narrowed neck portion 527 of
delivery tool head 520. Fixation member 560 thus becomes
substantially isodiametric with delivery tool head 520. As delivery
tool head 520 and fixation member 560 are tunneled to an implant
site a relatively narrow passage through the tissue is formed. A
smaller diameter of the delivery tool head with a mounted fixation
member will generally require lower tunneling forces. Upon release
of fixation member 560 from delivery tool head 520, fixation member
520 regains its normal shape. As described previously, fixation
member base 568 is formed with a greater stiffness than sides 562
and 564 such that base 568 will straighten upon release from tool
500 and thereby act to restore the generally triangular shape of
fixation member 560. The wide base 568 of fixation member 560 and
barbs 580 will inhibit the retraction of member 560 back through
the narrow tissue tunnel formed by delivery device 500.
[0073] FIGS. 18 and 19 are side and top views, respectively, of a
delivery tool distal portion having an alternative release
mechanism used for releasing a fixation member from the delivery
tool. A medical device 620 is shown mounted on delivery tool 600.
Medical device 620 includes an elongated body 622 coupled to a
receptacle 632 of fixation member 630. First and second sides of
fixation member 630 are not shown for the sake of clarity in
illustrating the release mechanism 604. Delivery tool 600 includes
a shaft 610 and delivery tool head 601. Delivery tool head 601
includes a restraint 602 for retaining the base 634 of fixation
member 630 in a stretched position.
[0074] Release mechanism 604 is embodied as a lever coupled to an
actuation member 606, embodied as a push-pull rod. Actuation member
606 extends to a proximal handle of delivery tool 600 where it is
attached to a mechanical switch (not shown) used to actuate release
mechanism 604 via actuation member 606. Restraint 602 includes a
groove 603 (FIG. 19) to allow longitudinal movement (along the tool
axis) of release mechanism 604, toward and away from base 634.
[0075] FIGS. 20 and 21 are side and top views, respectively, of the
distal portion of the delivery tool 600 shown in FIGS. 18 and 19
wherein the release mechanism has been actuated to release fixation
member 630 from delivery tool 600. Actuation of release mechanism
604 by a switch coupled to actuation member 606 causes release
mechanism 604 to slide proximally toward base 634. Base 634 will be
stretched slightly further by release mechanism 604 and pushed
upward, as indicated by the arrow in FIG. 20, until base 634 is
released from restraint 602. Fixation member 630 will then slip off
delivery tool head 601 allowing tool head to be retracted and
removed and leaving fixation member 630 at the implant site.
[0076] FIG. 22 is a side sectional view of an alternative
embodiment of a delivery tool release mechanism. An actuation
member may alternatively be provided in the form of a pull wire 652
and spring member 654 instead of a push-pull rod as shown in FIGS.
18-21A. Tension applied to pull wire 652 by way of a proximal
switch will pull release mechanism 650 proximally to release
fixation member 630 from restraint 660. Spring member 654 will
return release mechanism 650 back, distally, to its normal position
corresponding to retaining a fixation member by restraint 660.
Spring member 654 may be formed as a metal or polymer spring or an
elastic element. In some embodiments, release member 650 may be
designed having elastic properties that cause release member 650 to
return to a normal position when not activated by pull wire
652.
[0077] While particular embodiments of release mechanisms have been
shown and described herein, it is recognized that numerous delivery
tool configurations may be conceived which enable restraint and
release of a fixation member. Such arrangements may include a
lever, spring, rod, or other member actuated by a mechanical switch
for longitudinal or rotational movement that causes release of a
medical device fixation member from the delivery tool. The
particular details of such mechanisms may vary widely but such
variations are considered within the scope of the present
invention.
[0078] FIGS. 23 and 24 are side and top views, respectively, of an
alternative embodiment of a delivery tool. Delivery tool 700
includes a mounting portion 725 positioned proximal to tunneling
tip 722. Delivery tool 700 includes a shaft 702 having a contoured
surface 730 for accommodating an elongated body of a medical device
(not shown in FIGS. 23 and 24). Shaft 702 includes flanges 732 and
734 for inhibiting rotation and lateral movement of the medical
device relative to shaft 702 and a stop surface 728 to prevent
over-stretching of a fixation member mounted on delivery tool
700.
[0079] Delivery tool 700 further includes a delivery tool head 720
having a distal tunneling tip 722, a mounting portion 725 spaced
proximally from tunneling tip 722 and a narrowed neck portion 727
extending toward shaft 702. A restraint 726 is provided for
maintaining a fixation member in a stretched position when the
fixation member is mounted along groove 724 of mounting portion 725
as described previously. A fixation member mounted on delivery tool
head 720 is not exposed to the tunneling forces met by tunneling
tip 722.
[0080] Thus, a medical device system including an implantable
medical device having a fixation member and a delivery tool used
for deploying the device have been presented in the foregoing
description with reference to specific embodiments. It is
appreciated that various modifications to the referenced
embodiments may be made without departing from the scope of the
invention as set forth in the following claims.
* * * * *