U.S. patent application number 12/440149 was filed with the patent office on 2010-01-21 for method and apparatus for a two-way torque limited wrench.
Invention is credited to Scott Dahl, Benjamin R. Fruland, Kevin J. Persuitti.
Application Number | 20100016861 12/440149 |
Document ID | / |
Family ID | 39058297 |
Filed Date | 2010-01-21 |
United States Patent
Application |
20100016861 |
Kind Code |
A1 |
Fruland; Benjamin R. ; et
al. |
January 21, 2010 |
METHOD AND APPARATUS FOR A TWO-WAY TORQUE LIMITED WRENCH
Abstract
One embodiment of the present subject matter includes a system
(700) which includes a device (701) including a first body (702)
which is hermetically sealed, a first terminal (706) coupled to the
first body, a second body (704) which is part of the device and
which is hermetically sealed, a second terminal (708) coupled to
the second body, a threaded fastener (712) coupling the first
terminal and the second terminal and a torque wrench (716) matable
to the threaded fastener, the torque wrench including a tightening
clutch (604) and a loosening clutch (608), the tightening clutch
adapted to slip at a first torque, the loosening clutch adapted to
slip at a second torque other than the first torque. A method of
storing an implantable device (701) is also subject mater.
Inventors: |
Fruland; Benjamin R.;
(Plymouth, MN) ; Persuitti; Kevin J.; (Andover,
MN) ; Dahl; Scott; (Minneapolis, MN) |
Correspondence
Address: |
SCHWEGMAN, LUNDBERG & WOESSNER/BSC-CRM
PO BOX 2938
MINNEAPOLIS
MN
55402
US
|
Family ID: |
39058297 |
Appl. No.: |
12/440149 |
Filed: |
September 7, 2007 |
PCT Filed: |
September 7, 2007 |
PCT NO: |
PCT/US07/19603 |
371 Date: |
July 20, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60825052 |
Sep 8, 2006 |
|
|
|
Current U.S.
Class: |
606/104 ;
607/1 |
Current CPC
Class: |
A61N 1/3968
20130101 |
Class at
Publication: |
606/104 ;
607/1 |
International
Class: |
A61B 17/58 20060101
A61B017/58; A61N 1/39 20060101 A61N001/39 |
Claims
1-25. (canceled)
26. A system, comprising: a. a device including a first body which
is hermetically sealed; b. a first terminal coupled to the first
body; c. a second body which is part of the device and which is
hermetically sealed; d. a second terminal coupled to the second
body; e. a threaded fastener coupling the first terminal and the
second terminal; and f. a torque wrench matable to the threaded
fastener, the torque wrench including a tightening clutch and a
loosening clutch, the tightening clutch adapted to slip at a first
torque, the loosening clutch adapted to slip at a second torque
other than the first torque.
27. The system of claim 26, further comprising a wrench that is
mateable to the threaded fastener and that does not include a
clutch.
28. The system of claim 26, wherein the torque wrench includes a
regular hexagonal driver.
29. The system of claim 26, wherein the second body includes a
lead.
30. The system of claim 26, wherein the first torque is around 15
inch pounds and the second torque is around 22 inch pounds.
31. The system of claim 26, wherein the tightening clutch and the
loosening clutch do not include a lubricant.
32. The system of claim 31, wherein the torque wrench includes
plastic, with the tightening clutch and the loosening clutch both
being plastic.
33. The system of claim 26, wherein torque wrench includes a driver
which includes a stress riser.
34. The system of claim 33, wherein the stress riser is adapted to
fail at a torque which is greater than the first torque and the
second torque.
35. The system of claim 26, wherein the first body includes a case
including pulse generation electronics.
36. The system of claim 35, wherein the pulse generation
electronics include pacemaker electronics.
37. The system of claim 36, wherein the pulse generation
electronics include defibrillation electronics.
38. The system of claim 26, wherein the first terminal includes a
female recess and the second terminal includes a male terminal.
39. The system of claim 38, wherein the fastener has an at least
partially threaded body and a flanged head adapted to mate with the
torque wrench, the fastener disposed at least part of the way in
the female recess, the flange having a diameter which is larger
than a diameter of an at least partially threaded recess adapted to
receive the fastener, and further comprising a flexible septum
coupled to the first body and covering the at least partially
threaded recess, the flexible septum having an opening sized for
passage of the torque wrench.
40. The system of claim 39, wherein the opening includes a
slit.
41. The system of claim 39, wherein the flexible septum includes
silicone.
42. The system of claim 39, wherein the first terminal includes a
flexible septum coupled to the first body and covering the at least
partially threaded recess, the flexible septum having an opening
sized for passage of the torque wrench, a. wherein in a first mode
of operation, the male terminal is clamped between the first body
and the fastener, with the opening closed and sealed, and in a
second mode of operation, the male terminal is not clamped between
the first body and the fastener, and while in the second mode of
operation, the flange abuts the flexible septum such that the
opening is open and unsealed.
43. A method, comprising: a. coupling a female terminal and a male
terminal to connect an implantable lead to a body of an implantable
device; b. pinching the male terminal against a surface of the body
which is inside a recess defined by the female terminal by
torquing, with a torque wrench, a fastener to a first torque; and
c. unpinching the male terminal by untorquing the fastener at a
second torque, other than the first torque, which is less than a
torque large enough to cause inelastic deformation of the torque
wrench.
44. The method of claim 43, further comprising delivering
electrical pulses from the implantable device to an electrode of
the implantable lead over a conduction path through the male
terminal and the female terminal.
45. The method of claim 43, further comprising untorquing the
fastener with a second wrench at a torque which is greater than the
second torque.
46. The method of claim 43, further comprising scoring a driver of
the torque wrench to define a stress riser.
47. The method of claim 43, further comprising inserting a driver
of the torque wrench through a flexible septum coupled to the body
and covering an at least partially threaded recess in which the
fastener is disposed, the flexible septum having an opening sized
for passage of the driver.
48. A system, including: a. a device including a first body which
is hermetically sealed; b. a first terminal coupled to the first
body; c. a second body which is part of the device and which is
hermetically sealed; d. a second terminal coupled to the second
body; e. means for removably coupling the first terminal and the
second terminal by applying a torque; and f. means for torquing at
a first torque, and untorquing at a second torque other than the
first torque, the means for removably coupling the first terminal
and the second terminal by applying a torque.
49. The system of claim 48, wherein the means for removably
coupling the first terminal and the second terminal by applying a
torque include a threaded fastener.
50. The system of claim 48, wherein the means for torquing at a
first torque, and untorquing at a second torque other than the
first torque, the means for removably coupling the first terminal
and the second terminal by applying a torque include a torque
wrench including a tightening clutch and a loosening clutch, the
tightening clutch adapted to slip at a first torque, the loosening
clutch adapted to slip at a second torque other than the first
torque.
Description
CLAIM OF PRIORITY
[0001] Benefit of priority is hereby claimed to U.S. Provisional
Patent Application Ser. No. 60/825,052, filed on Sep. 8, 2006,
which application is herein incorporated by reference.
TECHNICAL FIELD
[0002] This disclosure relates generally to fasteners, and more
particularly to a method and apparatus for a fastener with a septum
seal cover.
BACKGROUND
[0003] There is an ongoing need to provide devices which can be
exposed to fluids without malfunctioning. Some designs cannot
simply be encased in a fluid compatible, sealed material, as they
must be manipulated in use. Such is the case with some devices
which are implanted in a person. Some implantable systems include
interchangeable components which conduct electricity. For example,
some designs use a set fastener to pinch a lead. Devices such as
these must provide reliable electrical and mechanical connection
which does not degrade in use.
[0004] Various problems are associated with such designs. Bodily
fluids can reduce the operability of these devices by binding
components to one another. As such, workers have attempted to
provide covers for these devices. However, many covers which
provide good sealing characteristics, such as silicone covers,
present a problem of bonding to other components, or to themselves,
in use and in storage.
[0005] An additional problem is that a fastener can become
misaligned, or skew to their mating feature, during surgery.
Further, some fastener designs encourage cross threading,
especially when a doctor is inserting a driver through a seal. When
inserting a driver through a seal, it is important to have the
fastener in alignment with the seal opening; some designs do not
encourage this. An additional problem is that some fastener designs
can crush and damage the leads they pinch.
SUMMARY
[0006] One embodiment of the present subject matter includes a
system which includes a device including a first body which is
hermetically sealed, a first terminal coupled to the first body, a
second body which is part of the device and which is hermetically
sealed, a second terminal coupled to the second body, a threaded
fastener coupling the first terminal and the second terminal and a
torque wrench matable to the threaded fastener, the torque wrench
including a tightening clutch and a loosening clutch, the
tightening clutch adapted to slip at a first torque, the loosening
clutch adapted to slip at a second torque other than the first
torque.
[0007] Another embodiment is contemplated which provides a method
which includes coupling a female terminal and a male terminal to
connect an implantable lead to a body of an implantable device,
pinching the male terminal against a surface of the body which is
inside a recess defined by the female terminal by torquing, with a
torque wrench, a fastener to a first torque and unpinching the male
terminal by untorquing the fastener at a second torque, other than
the first torque, which is less than a torque large enough to cause
inelastic deformation of the torque wrench.
[0008] One embodiment of the present subject matter includes a
system which includes a device including a first body which is
hermetically sealed, a first terminal coupled to the first body, a
second body which is part of the device and which is hermetically
sealed, a second terminal coupled to the second body, means for
removably coupling the first terminal and the second terminal by
applying a torque; and means for torquing at a first torque, and
untorquing at a second torque other than the first torque, the
means for removably coupling the first terminal and the second
terminal by applying a torque.
[0009] The present subject matter includes optional features in
additional embodiments. Some of those embodiments include a
fastener which is part of a cardiac rhythm management device, such
as a pacemaker or a defibrillator. Some embodiments include a
silicone cover. Some embodiments include a fastener having a convex
distal portion. Some embodiments include a fastener mateable to a
male hex driver. Embodiments include taking a device out of storage
and inserting a male terminal into the device, and securing that
terminal to the device using a fastener of the present subject
matter. Openings in covers of the present subject matter are
lubricated, in various embodiments. Other options are disclosed
herein.
[0010] One embodiment of the present subject matter includes a
system for fastening a male terminal with a driver. The embodiment
includes a body defining an at least partially threaded recess
which intersects with a female recess adapted to receive the male
terminal. The embodiment includes a fastener having an at least
partially threaded body and a flanged head adapted to mate with the
driver, the fastener disposed at least part of the way in the first
recess, the flange having a diameter which is larger than a
diameter of the at least partially threaded recess. The embodiment
includes a flexible septum coupled to the body and covering the
first recess, the flexible septum having an opening sized for
passage of the driver. In the embodiment, a first mode of
operation, the system is adapted to clamp the male terminal between
the body and the fastener, with the opening closed and sealed, and
in a second mode of operation the system is adapted to not clamp
the male terminal between the body and the fastener while the
flange abuts the flexible septum such that the opening is open and
unsealed.
[0011] Another embodiment is contemplated which provides a method
storing an implantable device. The embodiments include assembling a
fastener into a recess in a body of the implantable device, the
recess being covered by a flexible septum having a slit. The
embodiment further includes opening the slit by adjusting the
fastener with respect to the device such that a flange of the
fastener abuts the flexible septum. The embodiment includes
packaging the implantable device for storage. The embodiment
further includes storing the implantable device.
[0012] One embodiment of the present subject matter includes body
means for receiving a fastener and a male terminal. The embodiment
includes fastener means for securing the male terminal to the body
means, for limiting the travel of the fastener into the body means,
and for preserving alignment of the fastener means with respect to
the body means when the male terminal is not secured to the body
means. The embodiment further includes cover means for covering the
fastener and for sealing the fastener means and the body means.
[0013] The present subject matter includes optional features in
additional embodiments. Some of those embodiments include a
fastener which is part of a cardiac rhythm management device, such
as a pacemaker or a defibrillator. Some embodiments include a
silicone cover. Some embodiments include a fastener having a convex
distal portion. Some embodiments include a fastener mateable to a
male hex driver. Embodiments include taking a device out of storage
and inserting a male terminal into the device, and securing that
terminal to the device using a fastener of the present subject
matter. Openings in covers of the present subject matter are
lubricated, in various embodiments. Other options are disclosed
herein.
[0014] This Summary is an overview of some of the teachings of the
present application and not intended to be an exclusive or
exhaustive treatment of the present subject matter. Further details
about the present subject matter are found in the detailed
description and appended claims. Other aspects will be apparent to
persons skilled in the art upon reading and understanding the
following detailed description and viewing the drawings that form a
part thereof, each of which are not to be taken in a limiting
sense. The scope of the present invention is defined by the
appended claims and their legal equivalents.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1A illustrates a cross section of a fastener and a lead
in an unfastened position, according to one embodiment of the
present subject matter.
[0016] FIG. 1B illustrates a cross section of a fastener and a lead
in a fastened position, according to one embodiment of the present
subject matter.
[0017] FIG. 2 illustrates a cross section of a fastener and a lead
in a lead unfastened position, according to one embodiment of the
present subject matter.
[0018] FIG. 3A illustrates a partial side view of a cross section
of a fastener in an unfastened position, according to one
embodiment of the present subject matter.
[0019] FIG. 3B illustrates a top view of the view in FIG. 3A.
[0020] FIG. 4 illustrates a partial perspective view of a fastener,
according to one embodiment of the present subject matter.
[0021] FIG. 5 illustrates a partial cross section of a fastener,
according to one embodiment of the present subject matter.
[0022] FIG. 6 illustrates a torque wrench, according to some
embodiments of the present subject matter.
[0023] FIG. 7 illustrates a system including a torque wrench, a
fastener, and terminals, according to various embodiments of the
present subject matter.
[0024] FIG. 8 shows a method of connecting a lead and a body,
according to some embodiments of the present subject matter.
DETAILED DESCRIPTION
[0025] The following detailed description of the present subject
matter refers to subject matter in the accompanying drawings which
show, by way of illustration, specific aspects and embodiments in
which the present subject matter may be practiced. These
embodiments are described in sufficient detail to enable those
skilled in the art to practice the present subject matter.
References to "an", "one", or "various" embodiments in this
disclosure are not necessarily to the same embodiment, and such
references contemplate more than one embodiment. The following
detailed description is demonstrative and not to be taken in a
limiting sense. The scope of the present subject matter is defined
by the appended claims, along with the full scope of legal
equivalents to which such claims are entitled.
[0026] The present subject matter provides a connector for
connecting a terminal of one component of a system to another
component of a system. The terminals are male and female. In
various embodiments, the present subject matter provides a first
terminal for connection of an implantable lead to a second terminal
which is part of an implantable device. Devices contemplated
include, but are not limited to, cardiac rhythm management
electronics including, but not limited to, pacemakers,
defibrillators, cardioverter defibrillators. The present subject
matter additionally contemplates other devices which deliver an
electrical pulse to the body. Additional devices beyond these also
benefit from features disclosed herein. In various embodiments, the
terminal for the lead is male, although the present subject matter
is not so limited. Among the embodiments contemplated are those in
which a fastener is threaded into a device such that the fastener
may encroach into a recess of a female terminal of a device. As the
fastener is tightened, it pinches against a male terminal inserted
into the female terminal, in various embodiments. The present
subject matter contemplated embodiments in which the female
terminal is a portion of a lead, and the male terminal is a portion
of the device.
[0027] The present subject matter covers a range of fastener
embodiments. Some embodiments contemplated include threads.
Additional embodiments contemplated include fasteners which include
a shaft with grooves which are adapted to mate with pins in a
recess such that rotation of the fastener with respect to the
recess receives the pins in the grooves and draws the fastener into
the recess. Some of these embodiments limit the radial motion of
the fastener. For example, fasteners contemplated by the present
subject matter go from being uncoupled to a recess at 0 degrees
rotation, to fully coupled with a recess at 270 degrees rotation.
Some of these embodiments provide tactile feedback so a fastener
operator can feel when the fastener is fully engaged. Some
embodiments provide features in the grooves of the fastener, such
as ribs, which provide additional feedback. Such features
additionally may discourage disengagement of the fastener from the
recess.
[0028] Some embodiments of the present subject matter provide a
cover for the fastener. Various embodiments include a septum which
covers the fastener. In some of these embodiments, the septum
provides at least a partial seal against bodily fluids. In some
embodiments, the septum includes an opening through which a driver
can be inserted to adjust the fastener.
[0029] Various embodiments of the present subject matter provide an
improved fastener. Some embodiments provide a fastener with a
flanged head such that the fastener cannot be fastened into a
fastener hole beyond a predetermined depth. These embodiments work
to reduce damage to a male terminal during tightening of the
fastener. The flange serves additional functions as well. Some of
these are discussed herein.
[0030] Some embodiments provide a fastener having an unthreaded
portion which extends away from the threads and leads the fastener
into a mating fastener hole. These embodiments reduce instances of
the fastener tipping, or become skew with respect to its mating
recess, after it is disengaged from its recess. These embodiments
additionally reduce instances of a fastener going out of alignment
with an access opening in a cover which covers the fastener.
[0031] In various embodiments, materials which bond to themselves
or which bond to other objects over time are provided. For example,
in some embodiments, a silicone cover is provided with an opening
in it for accessing a fastener of the present subject matter. In
various embodiments, the fastener helps to keep an opening of a
cover open so that the opening does not stick close or bond closed.
In various embodiments, the fastener keeps an opening of the cover
open in storage. In some embodiments, the flanged head of the
fastener keeps the opening open. In some embodiment, the opening is
a slit, and is shaped to work in conjunction with the fastener to
open when the fastener is backed out of the recess.
[0032] FIG. 1A illustrates a cross section of a fastener and a lead
in an unfastened position, according to one embodiment of the
present subject matter. FIG. 1B illustrates a cross section of a
fastener and a lead in a fastened position, according to one
embodiment of the present subject matter. The illustrated fastener
106 is a set screw, but the present subject matter is not so
limited, as other fasteners, including fasteners having a head, are
contemplated by the present subject matter.
[0033] Various embodiments of the present subject matter provide a
system for fastening a fastener 106 with a driver. Drivers
contemplated by the present subject matter include a range of
interfaces. Interfaces contemplated by the present subject matter
include, but are not limited to, hex socket, hex head, TORX, slot,
PHILLIPS, and/or combinations thereof. This list is not exhaustive
or exclusive of the present subject matter, and additional
fasteners designs are also contemplated. TORX is a registered
trademark of Textron, Inc., which is incorporated in Delaware and
has an office at 40 Westminster Street in Providence, R.I. 02903.
PHILLIPS is a registered trademark of Phillips Screw Company, which
is incorporated in Delaware and has an office at 8 Mercer Road in
Natick, Mass. 01760. In some embodiments of the present subject
matter, the driver provides the male interface, and the fastener
provides the female interface. Additional embodiments are
contemplated in which the driver includes the female interface, and
the fastener includes the male interface. Additional drives which
engage fasteners using techniques not expressly disclosed here are
also contemplated.
[0034] Various embodiments of the present subject matter provide a
body 102 defining an at least partially threaded recess 112 for a
fastener. In various embodiments, the recess 112 includes a distal
portion 124 and a proximal portion 126. Bodies which are
contemplated by the present subject matter include housings for
implantable devices, as well as feedthroughs or headers which are
attached to one or more additional devices. Some of these
embodiments provide a body 102 which seals its contents. For
example, some bodies seal housed electronics from the encroachment
of bodily fluids.
[0035] In various embodiments, the recess intersects with a female
recess 110 adapted to receive the male terminal 108. Various male
terminals are contemplated by the present subject matter, including
male terminals for leads. Male terminals for sensors and for
stimulation electrodes which are not on a lead are also
contemplated. Other components having a male terminal are
additionally compatible with the present subject matter. Although
the illustrated embodiments shows a lead with a male terminal, and
a body with a female terminal, the present subject matter is not so
limited, and embodiments which are configured otherwise are
additionally contemplated. For example, various embodiments include
a body having a male terminal which is configured to mate with a
female terminal conducted to one or more devices. In some of these
embodiments, the female terminal is connected to a lead.
[0036] In various embodiments, a male terminal 108 is inserted into
the female terminal, and is pinched. In some of these embodiments,
pinching is performed by twisting a driver coupled to the fastener.
In various embodiments, the driver is torque limited. In additional
embodiments, the driver is not torque limited.
[0037] Various embodiments of the present subject matter include a
cover 104 for the fastener 106. In some embodiments, the cover 104
is integrated with the body 102. Some of these embodiments provide
a polymer body 102 and cover 104. This configuration is one
embodiment contemplated by the present subject matter. Additional
embodiments, in which the cover 104 is not integrated with the body
102 are contemplated as well.
[0038] In various embodiments, the fastener 106 includes a proximal
portion 114 and a distal portion 128. In various embodiments,
recess 116 is an opening countersunk into body 102. In some of
these embodiments, the recess 116 is cylindrical, but other shapes
are possible. In embodiments having such a recess, various
embodiments include a cover 104 which is fit into recess 116. In
various embodiments, the cover 104 is a plug which is interference
fit into recess 116. In various embodiments, the interference/fit
includes additional features, such as ribs, threads, teeth, or
other fastening features. In various embodiments, the fit of cover
104 into recess 116 is such that the fastener 106 can open an
opening 118 in cover 104 without unseating the cover 104 from the
recess 116.
[0039] In various embodiments, the cover 104 defines a septum which
defines a chamber 120 under which fastener 106 is disposed. Such a
relationship, in various embodiments, reduces instances of
encroachment of fluids into chamber 120. Although the pictured
embodiment includes a chamber 120 which is larger than the fastener
106, the present subject matter is not so limited and includes
chambers which are form fitting to the fastener. Such designs can
reduce the size of a device. In implanted embodiments, this can
result in improved patient comfort. In various embodiments, this
can also result in easier implantation procedures for care
givers.
[0040] In various embodiments, the septum is flexible. In various
embodiments, the septum includes silicone. In additional
embodiments, the septum is another polymer, or a combination of
another polymer and silicone. This is not an exhaustive or
exclusive list of the present subject matter, and additional
materials are contemplated.
[0041] In various embodiments, the septum includes an opening sized
for passage of a driver. Some embodiments of the present subject
matter include a septum having an opening sized for passage of a
hex head driver mateable to the fastener 106. In various
embodiments, the opening is sized such that the driver may pass
through the opening without tearing or otherwise harming the
opening.
[0042] In various embodiments, the present subject matter provides
a first mode of operation. One of these embodiments is depicted in
FIG. 1B. In that mode, a system of the present subject matter
clamps the male terminal between the body and the fastener, with
the opening closed and sealed. Some sealed embodiments provide a
seal which resists flow of bodily fluids. Additional seals within
the scope of the present subject matter do not resist the flow of
bodily fluids, but otherwise provide a seal. Examples of such seals
are seals which keep out dust. Other seals are additionally
contemplated by the present subject matter.
[0043] The present subject matter provides a second mode of
operation, in various embodiments. One of these embodiments is
depicted in FIG. 1A. The second mode includes a system of the
present subject matter which does not clamp the male terminal
between the body and the fastener. This second mode, in various
embodiments, includes a fastener 106 which abuts the septum 122
such that the opening is open and unsealed. In various embodiments,
the opening 118 is shaped like a slit in the cover 104. The present
subject matter includes openings having additional shapes as well,
such as circular holes adapted to seal unto themselves.
[0044] In various embodiments, the fastener 106 is radioopaque. In
some of these embodiments, care givers are able to better determine
the orientation of an implantable device with respect to a patient.
An additional benefit is that the engagement of the male terminal
with the female terminal can be studied without explant. This is
not an exhaustive or exclusive list of benefits provided.
[0045] FIG. 2 illustrates a cross section of a fastener 208 and a
lead 210 in a lead unfastened position, according to one embodiment
of the present subject matter. A cover 206 is provided. In the
illustration, the cover is flexed such that an opening 214 is
demonstrated. In various embodiments, the opening 214 is large
enough for the fastener 208 to pass through. In various
embodiments, a driver which can couple with the fastener and apply
a torque to the fastener is contemplated.
[0046] The fastener 208 illustrated is one of a range of
embodiments which are partially threaded. The fastener includes a
proximal end 222 and a distal end 220. The fastener includes a
threaded portion 204 and an unthreaded portion 202. In various
embodiments, the fastener is partially engaged with the recess 218.
The recess 218 includes a proximal end 224 and a distal end 226. In
various embodiments, the unthreaded portion 202 extends into the
recess and at least partially engages the recess 218. One or more
threads of the fastener 208 may engage one or more threads of the
recess 218, in various embodiments.
[0047] In some of the embodiments in which the threaded portion of
the fastener 208 is not fully threaded into the recess 218, a
device operator is extracting fastener 208 from the recess 218. An
operator may seek to perform such an operation for various reasons.
One reason is that a care giver might want to explant a first
device to replace it with a second device. The care giver may want
to mate the lead of the first device to the second device. Other
reasons are additionally contemplated. In these situations, the
care giver backs the fastener 208 out of the recess 218 using
multiple turns with a driver. In some of these embodiments, the
care giver backs the fastener 208 out of the recess 218 until no
threads of the fastener 208 engage threads of the recess 218. In
embodiments which do not include a threaded portion 212 of the
fastener 208, the fastener 208 might tip or otherwise go out of
alignment with the recess 218, making reinsertion of the fastener
208 into the recess 218 more difficult. Embodiments of the present
subject matter address this issue. Embodiments may additionally
address issues not recited herein expressly.
[0048] Some embodiments of the present subject matter reduce the
need to include features in recess 218 which stop the progress of
fastener 208 as it is positioned within recess 218. For example,
some embodiments of the present subject matter which do not include
unthreaded portion 220 can tip upon extraction from the recess 218.
As such, in some embodiments, a fastener is fully disposed in a
recess. A stopper is then inserted near the proximal end 224 of the
recess such that the fastener cannot be removed easily from the
recess 218, in various embodiments. One example of a stopper is a
washer welded into recess 218, but other embodiments are
contemplated. These embodiments present an issue when an operator
uses excessive torque in an attempt to overcome the stopper without
realizing that the stopper is impeding the progress of the
extraction of the fastener from the recess. The issue is that the
stopper and the fastener can become wedged together. To reduce
instances of wedging, the present subject matter provides an
unthreaded portion 212 to reduce instances of tipping.
[0049] FIG. 3A illustrates a partial side view of a cross section
of a fastener in an unfastened position, according to one
embodiment of the-present subject matter. FIG. 3B illustrates a top
view of the view in FIG. 3A. Various embodiments include a fastener
310 which is fastened to body 312. In various embodiments, the
fastener includes a flanged portion 304. The fastener additionally
includes a recess 306 mateable to a driver, in various embodiments.
In additional embodiments, the fastener is a hex head fastener.
Embodiments are contemplated in which the fastener 310 does not
include a recess 306 and is actuated another way.
[0050] Various embodiments include a cover 302. In some of these
embodiments, the cover 302 has a slit 308. In various embodiments,
the slit is closeable such that it seals a chamber 314. In some
embodiments, the chamber 314 is sealed from the encroachment of
bodily fluids into the chamber 314.
[0051] In some embodiments, the cover 302 is manufactured from
silicone. Over prolonged periods of time, two pieces of silicone
can partially or fully bond together when put into contact with one
another. As such, the present subject matter provides an operator
of the fastener 310 the option to store device 316 with the
fastener configured as illustrated in FIG. 3A. The fastener
includes a flange 304 which is oversized, having a large diameter
than the diameter of the recess 318. This allows for various
functions. One function is to hold open an opening in the cover 302
so that silicone does not bond with itself. Another function is to
limit the travel of the fastener 310 into the recess 318. Such a
limit can protect against crushing of a male terminal which the
fastener 310 cinches against the body 312. In some embodiments, if
a fastener system can protect against crushing, device 316 sellers
do not have to package the device with a torque limited driver.
Further, reducing instances of crushing can reduce the need to
train operators on how to avoid crushing a terminal while operating
fastener 310. Another benefit of the present subject matter is that
the opening in the cover 302 provides a visual cue that the
fastener 310 is not yet inserted into the recess 318.
[0052] FIG. 4 illustrates a partial perspective view of a fastener,
according to one embodiment of the present subject matter. The
fastener 402, in various embodiments, includes a recess 404. In
some of these embodiments, the recess 404 is a hex socket, as
pictured. Embodiments of the present subject matter additionally
include a slot 406, either alone, or in combination with another
feature suited for coupling fastener 402 with a driver. Embodiments
may additionally include other features as disclosed herein.
[0053] FIG. 5 illustrates a partial cross section of a fastener,
according to one embodiment of the present subject matter.
Illustrated is a fastener 506, according to some embodiments of the
present subject matter. The illustrated cross section is the distal
portion of a fastener 506. The fastener includes a threaded portion
504. Additional embodiments are not threaded. In various
embodiments, the distal end of the fastener 506 is substantially
convex. In some embodiments, the substantially convex feature
includes a substantially planar portion 508 and a bevel 502.
Additional shapes are possible, however, including a partial sphere
shape, in some embodiments.
[0054] Various processes are contemplated by the present subject
matter. Some embodiments of the present subject matter include a
method storing an implantable device. Some of these embodiments
include assembling a fastener into a recess in a body of the
implantable device. In some embodiments, the recess is covered. In
some of these embodiments, the recess is covered by a flexible
septum.
[0055] In some embodiments, the septum has an opening. In some of
these embodiments, the opening is a slit. In some embodiments, the
slit may be opened by adjusting the fastener with respect to the
device. In some embodiments, the fastener backs into the septum and
forces the slit open. In some embodiments, the fastener includes a
flange which aids in opening the slit. In some embodiments
including a flange, the flange of the fastener abuts the flexible
septum. The flange additionally prevents overtorquing of the
fastening during tightening, in various embodiments.
[0056] Some embodiments include packaging the implantable device
for storage. Some embodiments include storing the implantable
device. Storage practices contemplated include, but are not limited
to, warehousing, storing with a reseller, storing with a sales
person, and other storing practices not recited herein
expressly.
[0057] An additional process contemplated by the present subject
matter includes removing the device from storage and inserting a
male terminal into the body of the implantable medical device. Some
of these embodiments include coupling the male terminal to the body
of the device by tightening the fastener against the male
terminal.
[0058] Additional processes contemplated by the present subject
matter include applying a lubricant to the slit. Examples of
lubricants contemplated by the present subject matter include, but
are not limited to, MDX4-4159, NuSil MED420, MED-4159, MED-4162,
MED1-4162, and/or NUSIL, and combinations thereof. NUSIL is a
registered trademark of NUSIL TECHNOLOGY headquartered in
Carpinteria, Calif., USA. MDX4-4159, NuSil MED420, MED-4159,
MED-4162, MED1-4162 each are manufactured by DOW CORNING, which is
headquartered in Midland, Mich., USA.
[0059] The present subject matter additionally contemplates
bundling the implantable device with a torque limited driver for
adjusting the fastener. In various embodiments, the torque driver
is torque limited during tightening. In additional embodiments, the
torque driver is torque limited during loosening. Torque drivers
which are torque limited during tightening and loosening are
additionally contemplated by the present subject matter.
Embodiments are contemplated in which a non-torque limited driver
is bundled with a device of the present subject matter.
[0060] FIG. 6 illustrates a torque wrench, according to some
embodiments of the present subject matter. Various embodiments
include a torque wrench 600. Some embodiments include a torque
wrench having head 602 which includes a first clutch 604. In
various embodiments, a handle 606 is included to provide mechanical
advantage. The first clutch 604 provides a specified amount of
torque during torquing and slips when that torque is exceeded. The
specified torque can be reached during tightening only, during
loosening only, or during both tightening and loosening. Some
embodiments which provide for slipping at a specified torque during
both tightening and loosening include a switch to toggle between
tightening mode and loosening mode. Additional embodiments do not
require a switch to switch between tightening mode and loosening
mode.
[0061] Various embodiments click when the specified torque is
reached. Some embodiments do not click when the specified torque is
reached. Some embodiments provide tactile feedback when a specified
torque is reached.
[0062] In some examples, the specified torque is predetermined and
a care provider cannot adjust the torque. For example, some
embodiments include a first clutch 604 which slips at a specified
torque, and which is not adjustable without remanufacturing the
clutch.
[0063] Some embodiments include a second clutch 608 which slips at
a different torque than the first clutch 604 slips at. Such
embodiments can provide a first torque during tightening, and a
second torque during loosening. The second clutch can be adjustable
or nonadjustable, and can optionally provide feedback (e.g.,
audible, tactile) if desired. As such, some examples provide a
torque wrench including a tightening clutch and a loosening clutch,
the tightening clutch adapted to slip at a first torque, the
loosening clutch adapted to slip at a second torque other than the
first torque.
[0064] In various embodiments, the torque wrench 600 includes a
driver 610. The driver can be any of the drivers discussed here,
including hex drivers. In various embodiments, the driver includes
a stress riser 612. The stress riser, in various embodiments, is
intended to facilitate a controlled failure of the driver 610 under
torque. For example, in some embodiments, first clutch slips as a
first torque (e.g., around 15 inch pounds during tightening),
second clutch slips at a second torque (e.g., around 22 inch pounds
during loosening), and the stress riser causes a controlled break
of driver 610 at a torque above the second torque. Such a design
reduces instances of debris in a wound during driver 610 breakage.
In various embodiments, the stress riser 612 is the result of
scoring. Scoring can include cast features, ground features,
excised features, pressed features, and other features which result
in a stress riser.
[0065] In various embodiments, tightening clutch does not include
lubricant. In additional embodiments, the clutch does not include a
lubricant. Some embodiments incorporate a torque wrench which
includes plastic, such as a plastic handle or one or more plastic
clutch housing. Some embodiments include a tightening clutch which
is plastic. Additional embodiments include a loosening clutch which
is plastic.
[0066] FIG. 7 illustrates a system 700 including a torque wrench, a
fastener, and terminals, according to various embodiments of the
present subject matter. Illustrated is a device 701 which includes
a first body 702 and a second body 704. In various embodiments, the
first body 702 and the second body 704 are implantable. In various
embodiments, one or both of the first body 702 and the second body
704 are hermetically sealed. Various embodiments include a first
terminal 706. The first terminal includes a physical component
which couples the first terminal 706 to the first body 702 in
various embodiments. For example, in some embodiments, including
the illustrated embodiment, the first terminal 706 is a recess
defined in part by the first body 702. Such a configuration
provides a female terminal. Other configurations are possible,
including embodiments which the first terminal 706 is not a female
terminal.
[0067] Additionally provided in various embodiments is a second
terminal 708. In various embodiments, the second terminal 708 is
coupled to the second body 704. Some embodiments, including the
illustrated embodiment, provide a second body 704 and a second
terminal 708 which is mateable to a recess, such as the first
terminal 706. Such a configuration provides a male terminal. In
various embodiments, a conductor 707 is included in the first
terminal 706. The second terminal 708 additionally includes
conductor (e.g., a metallic coating) so that, when connected, the
first terminal 706 can conduct electrical current with the second
terminal 708. The illustrated conductor 707 includes metal, and the
illustrated second terminal 708 includes at least a metal coating.
In various embodiments, the first terminal 706 is integrated with
the conductor, such as by potting or by another method. In some
embodiments, the entire first terminal includes conductor. Other
conductor configurations are possible, including male/female
parings for the conductors, and other conductor connection
configurations. Some embodiments include a seal 710 which seals one
or more conductors from the ambient atmosphere of system 700.
[0068] Various embodiments include a fastener 712. Some embodiments
include a threaded fastener. The threaded fastener illustrated is
disposed at least partially across the female terminal 706. The
threaded fastener is disposed in an at least partially threaded
recess adapted to receive the fastener, in various embodiments. In
some embodiments, the first body 702 defines a recess to receive
the fastener 712. In various embodiments, the fastener 712 couples
the male terminal and the female terminal. In various embodiments,
the fastener 712 has an at least partially threaded body and a
flanged head adapted to mate with the torque wrench 716, the
fastener disposed at least part of the way in the female recess
(e.g., the first terminal 706), the flange having a diameter which
is larger than a diameter of an at least partially threaded recess
adapted to receive the fastener.
[0069] Some embodiments include a seal 714 which seals the fastener
and the recess in which the fastener is disposed. In some
embodiments, the seal 714 seals the fastener 712 from exposure to
the atmosphere of system 700. In various embodiments, the seal 714
includes a flexible septum coupled to the first body 702 and
covering the at least partially threaded recess, the flexible
septum having an opening sized for passage of the torque wrench. In
various embodiments, an opening includes a slit. In some
embodiments, the flexible septum includes silicone.
[0070] Various embodiments include a torque wrench 716 which is
matable to the threaded fastener 712. In various embodiments, the
torque wrench includes a head 718 which includes at least one
clutch (e.g., a tightening clutch and a loosening clutch). The
torque wrench 716 includes a driver 720 in various embodiments.
Various embodiments include a wrench that is mateable to the
threaded fastener and that does not include a clutch. A standard
L-shape or T-shaped style hex wrench is provided in various
embodiments. Some of these embodiments include a stress riser.
[0071] In various embodiments, in a first mode of operation, the
male terminal 704 is clamped between the first body 702 and the
fastener 712. In various embodiments, in a second mode of
operation, the male terminal 704 is not clamped between the first
body 702 and the fastener 712. If the system 700 includes a septum
as part of the seal 714, that septum functions, in some
embodiments, as do septums mentioned in other discussions in this
document.
[0072] In various embodiments, the first body 712 includes a case
including pulse generation electronics. Titanium cases are
contemplated in some embodiments. Cases which are hermetically
sealed are also contemplated. In various embodiments, the pulse
generation electronics include pacemaker electronics. In additional
embodiments, the pulse generation electronics include
defibrillation electronics.
[0073] FIG. 8 shows a method 800 of connecting a lead and a body,
according to some embodiments of the present subject matter. At
802, various embodiments include coupling a female terminal and a
male terminal to connect an implantable lead to a body of an
implantable device. At 804, various embodiments include pinching
the male terminal against a surface of the body inside the female
recess by torquing a fastener to a first torque. In various
embodiments, a torque wrench is used to apply the torque. At 806,
various embodiments include unpinching the male terminal by turning
the fastener to a second torque. In some of these embodiments, the
second torque is less than a torque large enough to cause inelastic
deformation of the torque wrench. Various embodiments include
untorquing the fastener with a second wrench at a torque which is
greater than the second torque. Some embodiments include delivering
electrical pulses from the implantable device to an electrode of
the implantable lead over a conduction path through the male
terminal and the female terminal.
[0074] Some embodiments include a torque wrench with a driver. In
some of these embodiments, the driver is scored. As such, various
embodiments include scoring a driver of the torque wrench to define
a stress riser. Various additional embodiments include inserting a
driver of the torque wrench through a flexible septum coupled to
the body and covering an at least partially threaded recess in
which the fastener is disposed, the flexible septum having an
opening sized for passage of the driver.
[0075] Although specific embodiments have been illustrated and
described herein, it will be appreciated by those of ordinary skill
in the art that any arrangement which is calculated to achieve the
same purpose may be substituted for the specific embodiment shown.
This application is intended to cover adaptations or variations of
the present subject matter. It is to be understood that the above
description is intended to be illustrative, and not restrictive.
Combinations of the above embodiments, and other embodiments will
be apparent to those of skill in the art upon reviewing the above
description. The scope of the present subject matter should be
determined with reference to the appended claims, along with the
full scope of equivalents to which such claims are entitled.
* * * * *