U.S. patent application number 12/815364 was filed with the patent office on 2010-09-30 for straight cutting tip for a full large bore subcutaneous implantation instrument.
Invention is credited to Gust H. Bardy.
Application Number | 20100249696 12/815364 |
Document ID | / |
Family ID | 38541947 |
Filed Date | 2010-09-30 |
United States Patent
Application |
20100249696 |
Kind Code |
A1 |
Bardy; Gust H. |
September 30, 2010 |
STRAIGHT CUTTING TIP FOR A FULL LARGE BORE SUBCUTANEOUS
IMPLANTATION INSTRUMENT
Abstract
A straight cutting tip for a full large bore subcutaneous
implantation instrument is provided. An incising shaft body defines
an axial bore extending continuously throughout the incising shaft
body's length. The axial bore is open on both distal and proximal
ends of the incising shaft body and has a non-circular cross
section of at least five millimeters. A beveled surface is
transversely formed beginning on a top surface and ending on a
bottom surface of the incising shaft body. A cutting tip with a
pair of longitudinal straight cutting edges is formed on each side
and is progressively defined outwardly from the cutting tip to the
sides of the beveled surface at the bottom surface of the incising
shaft body. An attachment point is formed on the proximal end of
the incising shaft body.
Inventors: |
Bardy; Gust H.; (Seattle,
WA) |
Correspondence
Address: |
CASCADIA INTELLECTUAL PROPERTY
500 UNION STREET, SUITE 1005
SEATTLE
WA
98101
US
|
Family ID: |
38541947 |
Appl. No.: |
12/815364 |
Filed: |
June 14, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11484084 |
Jul 10, 2006 |
7736330 |
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12815364 |
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11345617 |
Feb 1, 2006 |
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11484084 |
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11025770 |
Dec 20, 2004 |
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11345617 |
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10222719 |
Aug 15, 2002 |
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11025770 |
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09644666 |
Aug 24, 2000 |
6436068 |
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10222719 |
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Current U.S.
Class: |
604/60 |
Current CPC
Class: |
A61B 2017/3492 20130101;
Y10T 29/49826 20150115; A61M 37/0069 20130101; A61B 17/3468
20130101; A61B 2560/063 20130101 |
Class at
Publication: |
604/60 |
International
Class: |
A61M 31/00 20060101
A61M031/00 |
Claims
1. A straight cutting tip for a full large bore subcutaneous
implantation instrument, comprising: an incising shaft body that
defines an axial bore extending continuously throughout the
incising shaft body's length, wherein the axial bore is open on
both distal and proximal ends of the incising shaft body and has a
non-circular cross section of at least five millimeters; a beveled
surface transversely formed beginning on a top surface and ending
on a bottom surface of the incising shaft body; a cutting tip with
a pair of longitudinal straight cutting edges formed on each side
and progressively defined outwardly from the cutting tip to the
sides of the beveled surface at the bottom surface of the incising
shaft body; and an attachment point formed on the proximal end of
the incising shaft body.
2. A straight cutting tip according to claim 1, further comprising:
a syringe body that defines an axial bore extending continuously
throughout the syringe body's length, wherein the axial bore is
open on both distal and proximal ends of the syringe body and has a
non-circular cross section approximately equal to the incising
shaft body's axial bore, wherein the distal end of the syringe body
is attached to the incising shaft at the attachment point.
3. A straight cutting tip according to claim 2, further comprising:
a plunger assembly comprising handle and a plunger connected by a
plunger shaft with a combined length exceeding the lengths of the
bores of the incising shaft body and the syringe body, wherein the
plunger and plunger shaft are shaped to follow the cross sectional
contour of the incising shaft body and the syringe body.
4. A curved cutting tip for a full large bore subcutaneous
implantation instrument, comprising: an incising shaft body that
defines an axial bore extending continuously throughout the
incising shaft body's length, wherein the axial bore is open on
both distal and proximal ends of the incising shaft body and has a
non-circular cross section of at least five millimeters; a beveled
surface transversely formed beginning on a top surface and ending
on a bottom surface of the incising shaft body; a cutting tip with
a pair of longitudinal curved cutting edges formed on each side and
progressively defined concave outwardly from the cutting tip to the
sides of the beveled surface at the bottom surface of the incising
shaft body; and an attachment point formed on the proximal end of
the incising shaft body.
5. A curved cutting tip according to claim 4, wherein the curved
cutting edges are further defined concave upwardly.
6. A curved cutting tip according to claim 4, further comprising: a
syringe body that defines an axial bore extending continuously
throughout the syringe body's length, wherein the axial bore is
open on both distal and proximal ends of the syringe body and has a
non-circular cross section approximately equal to the incising
shaft body's axial bore, wherein the distal end of the syringe body
is attached to the incising shaft at the attachment point.
7. A curved cutting tip according to claim 6, further comprising: a
plunger assembly comprising handle and a plunger connected by a
plunger shaft with a combined length exceeding the lengths of the
bores of the incising shaft body and the syringe body, wherein the
plunger and plunger shaft are shaped to follow the cross sectional
contour of the incising shaft body and the syringe body.
8. A straight cutting tip for a partial large bore subcutaneous
implantation instrument, comprising: an incising shaft body that
defines an axial bore extending part way through the incising shaft
body's length and a plunger bore communicatively connected to the
axial bore, wherein the axial bore is open on only a distal end of
the incising shaft body and has a non-circular cross section of at
least five millimeters, and the plunger bore is open on only a
proximal end of the incising shaft body; a beveled surface
transversely formed beginning on a top surface and ending on a
bottom surface of the incising shaft body; a cutting tip with a
pair of longitudinal straight cutting edges formed on each side and
progressively defined outwardly from the cutting tip to the sides
of the beveled surface at the bottom surface of the incising shaft
body; and an attachment point formed on the proximal end of the
incising shaft body.
9. A straight cutting tip according to claim 8, further comprising:
a syringe body that defines an axial syringe bore extending
continuously throughout the syringe body's length, wherein the
axial syringe bore is open on both distal and proximal ends of the
syringe body, wherein the distal end of the syringe body is
attached to the incising shaft at the attachment point, and the
plunger bore communicatively connected to the axial syringe
bore.
10. A straight cutting tip according to claim 9, further
comprising: a plunger assembly comprising handle and a plunger
connected by a plunger shaft with a combined length exceeding the
lengths of the bores of the incising shaft body and the syringe
body, wherein the plunger and plunger shaft are shaped to follow
the cross sectional contour of the incising shaft body and the
syringe body.
11. A curved cutting tip for a partial large bore subcutaneous
implantation instrument, comprising: an incising shaft body that
defines an axial bore extending part way through the incising shaft
body's length and a plunger bore communicatively connected to the
axial bore, wherein the axial bore is open on only a distal end of
the incising shaft body and has a non-circular cross section of at
least five millimeters, and the plunger bore is open on only a
proximal end of the incising shaft body; a beveled surface
transversely formed beginning on a top surface and ending on a
bottom surface of the incising shaft body; a cutting tip with a
pair of longitudinal curved cutting edges formed on each side and
progressively defined concave outwardly from the cutting tip to the
sides of the beveled surface at the bottom surface of the incising
shaft body; and an attachment point formed on the proximal end of
the incising shaft body.
12. A curved cutting tip according to claim 11, wherein the curved
cutting edges are further defined concave upwardly.
13. A curved cutting tip according to claim 11, further comprising:
a syringe body that defines an axial syringe bore extending
continuously throughout the syringe body's length, wherein the
axial syringe bore is open on both distal and proximal ends of the
syringe body, wherein the distal end of the syringe body is
attached to the incising shaft at the attachment point, and the
plunger bore communicatively connected to the axial syringe
bore.
14. A curved cutting tip according to claim 13, further comprising:
a plunger assembly comprising handle and a plunger connected by a
plunger shaft with a combined length exceeding the lengths of the
bores of the incising shaft body and the syringe body, wherein the
plunger and plunger shaft are shaped to follow the cross sectional
contour of the incising shaft body and the syringe body.
15. An upwardly curved cutting tip for a full large bore
subcutaneous implantation instrument, comprising: an incising shaft
body concavely curved on a top surface in an arc of approximately
20.degree. that defines an axial bore extending continuously
throughout the incising shaft body's length, wherein the axial bore
is open on both distal and proximal ends of the incising shaft body
and has a non-circular cross section of at least five millimeters;
a beveled surface transversely formed beginning on the top surface
and ending on a bottom surface of the incising shaft body; a
cutting tip with a pair of longitudinal straight cutting edges
formed on each side and progressively defined outwardly from the
cutting tip to the sides of the beveled surface at the bottom
surface of the incising shaft body; and an attachment point formed
on the proximal end of the incising shaft body.
16. An upwardly curved cutting tip according to claim 15, further
comprising: a syringe body concavely curved on a top surface in an
arc approximately equal to the incising shaft's arc and that
defines an axial bore extending continuously throughout the syringe
body's length, wherein the axial bore is open on both distal and
proximal ends of the syringe body and has a non-circular cross
section approximately equal to the incising shaft body's axial
bore, wherein the distal end of the syringe body is attached to the
incising shaft at the attachment point.
17. An upwardly curved cutting tip according to claim 16, further
comprising: a plunger assembly comprising handle and a plunger
connected by a curved plunger shaft curved on a top surface in an
arc approximately equal to the incising shaft's arc with a combined
length exceeding the lengths of the bores of the incising shaft
body and the syringe body, wherein the plunger and plunger shaft
are shaped to follow the cross sectional contour of the incising
shaft body and the syringe body.
18. A cutting tip for a large full bore subcutaneous implantation
instrument with penetration limiting mechanism, comprising: an
incising shaft body that defines an axial bore extending
continuously throughout the incising shaft body's length, wherein
the axial bore is open on both distal and proximal ends of the
incising shaft body and has a non-circular cross section of at
least five millimeters; a stopping flange mounted on a bottom
surface of the incising shaft body at an angle of between
approximately 30.degree. and 60.degree. bent in a proximal
direction; a beveled surface transversely formed beginning on a top
surface and ending on the bottom surface of the incising shaft
body; a cutting tip with a pair of longitudinal straight cutting
edges formed on each side and progressively defined outwardly from
the cutting tip to the sides of the beveled surface at the bottom
surface of the incising shaft body; and an attachment point formed
on the proximal end of the incising shaft body.
19. A cutting tip for a polygonal large bore subcutaneous
implantation instrument, comprising: an incising shaft body that
defines an axial bore extending continuously throughout the
incising shaft body's length, wherein the axial bore is open on
both distal and proximal ends of the incising shaft body and has a
cross section in the shape of a simple closed polygon with a height
of at least five millimeters; a beveled surface transversely formed
beginning on a top surface and ending on a bottom surface of the
incising shaft body; a cutting tip with a pair of longitudinal
straight cutting edges formed on each side and progressively
defined outwardly from the cutting tip to the sides of the beveled
surface at the bottom surface of the incising shaft body; and an
attachment point formed on the proximal end of the incising shaft
body.
20. A cutting tip according to claim 19, wherein the simple closed
polygon comprises one of a rectangular, square, pentagonal,
hexagonal, heptagonal, and octagonal shape.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This patent application is a continuation application of
U.S. patent application Ser. No. 11/484,084, filed Jul. 10, 2006,
pending; which is a continuation-in-part of U.S. patent application
Ser. No. 11/345,617, filed Feb. 1, 2006, pending; which is a
continuation of U.S. patent application Ser. No. 11/025,770, filed
Dec. 20, 2004, abandoned; which is a continuation of U.S. patent
application Ser. No. 10/222,719, filed Aug. 15, 2002, abandoned;
which is a continuation of U.S. Pat. No. 6,436,068, issued Aug. 20,
2002, the priority dates of which are claimed and the disclosures
of which are incorporated by reference.
FIELD
[0002] The present invention relates in general to subcutaneous
implantation instruments and methods and, in particular, to a
straight cutting tip for a full large bore subcutaneous
implantation instrument.
BACKGROUND
[0003] Health care assessment includes the review and analysis of
physiometry collected and recorded by electronic data sensors. The
type and quality of physiometry can depend upon the type and
location of sensor used. External sensors, such as thermometers,
blood pressure cuffs, heart rate monitors, and the like, are
limited in the kinds of information, which they are able to
collect, and can encumber the patient. Implantable in situ sensors
can provide a direct stream of recorded physiometry, but are
invasive and require surgical implantation.
[0004] Recent advances in microchip technology have created a new
generation of highly integrated, implantable sensors and medical
devices, such as implantable cardioverter defibrillators,
pacemakers, and insertable loop recorders. For instance, PCT
Publication Nos. WO/2000/004945, to Habib et al., published Feb. 3,
2000, and WO/2000/004946, to Habib et al., published Feb. 3, 2000,
respectively describe an implantable sensor chip and treatment
regiment, the disclosures of which are incorporated by reference.
Each sensor chip can collect and transmit physiometric data by
wireless telemetry to a receiver external to a body. Similarly, the
emerging Bluetooth wireless communication standard, described at
http://www.bluetooth.com/developer/specification/specification.asp,
proposes a low cost, small form factor solution for short range
data communications, potentially suitable for use in implantable
sensor technology.
[0005] Nevertheless, microchip sensors must still be implanted via
some form of surgical procedure. Minimally invasive implantation
using large bore needles or flat-edged blades is impracticable
because sensors, particularly when embodied using microchip
technology, favor a prismatic shape with substantially rectangular
cross sections that are incompatible with circular bores. As well,
large bore needles can core out flesh, skin, or hide, when used in
animals, as the instruments are inserted subcutaneously, which
creates a risk of infection. Moreover, wider-tipped instruments,
such as a hollow point chisel, can potentially cause tearing,
gouging, or similar injury due to the width of the cutting
edge.
[0006] In addition, although current surgical implantation
approaches attempt to minimize the size of incision and degree of
invasiveness, implantation is, at best, costly, time-consuming,
traumatic, requires multiple instruments and maneuvers, and
potentially risky to the patient. For example, anesthetizing is
conventionally performed using a topical or local anesthetic agent
on the implantation site.
[0007] Subcutaneous implantable sensors offer the best compromise
between in situ sensors and external sensors and are potentially
insertable with a simple injection, rather than surgical procedure.
These sensors are typically implanted below the dermis in the layer
of subcutaneous fat. Several approaches to the subcutaneous
implantation of solid materials have been described.
[0008] An insertion and tunneling tool for a subcutaneous wire
patch electrode is described in U.S. Pat. No. 5,300,106, to Dahl et
al., issued Apr. 5, 1994. The tunneling tool includes a stylet and
a peel-away sheath. The tunneling tool is inserted into an incision
and the stylet is withdrawn once the tunneling tool reaches a
desired position. An electrode segment is inserted into the
subcutaneous tunnel and the peel-away sheath is removed. Although
providing a tool for subcutaneous implantation, the Dahl device
requires an incision into the subcutaneous fat layer and forms an
implantation site larger than the minimum sized required by the
electrode segment. Further more, the cylindrical bore precludes the
injection of non-conforming solid sensors or materials.
[0009] An implant system for animal identification that includes a
device for implanting an identification pellet in a fat layer
beneath the hide or skin of an animal is described in U.S. Pat. No.
4,909,250, to Smith, issued Mar. 20, 1990. The device includes a
curved needle-like tube that terminates at a tapered, sharpened
point. An elongated, flexible plunger is slidably received within
the needle-like tube. The pointed tip is inserted through the hide
or skin and the plunger is actuated to drive the identification
pellet from the tip into the fat layer. However, the Smith device
uses an oversized open bore which can cause coring of the hide or
flesh.
[0010] A trocar for inserting implants is described in PCT
Publication No. WO/1999/053991, to Peery, published Oct. 28, 1999.
An implant retention trocar includes a cannula for puncturing the
skin of an animal and an obturator for delivering the implant. A
spring element received within the cannula prevents an implant from
falling out during the implant process. The cannula has a distal
tip design which causes a minimum of trauma and tearing of tissue
during implant insertion. However, the distal tip design is
specifically directed to cannulas having a substantially circular
bore and thereby limits the size and shape of implant which can be
inserted through the Clarke trocar.
[0011] An instrument for injecting implants through animal hide is
described in U.S. Pat. No. 5,304,119, to Balaban et al., issued
Apr. 19, 1994. The instrument includes an injector having a tubular
body divided into two adjacent segments with a hollow interior
bore. A pair of laterally adjacent tines extend longitudinally from
the first segment to the distal end of the tubular body. A plunger
rod has an exterior diameter just slightly larger than the interior
diameter of the tubular body. With the second segment inserted
beneath the animal hide, the push rod is advanced longitudinally
through the tubular body, thereby pushing the implant through the
bore. As the implant and rod pass through the second segment, the
tines are forced radially away from each other, thereby dilating or
expanding the incision, and facilitating implant. The instrument is
removed from the incision following implantation. Though avoiding
the coring of animal hide or flesh, the instrument forms an
implantation site larger than the minimum sized required by the
implant and causes potentially damaging compaction of the implant
against the laterally adjacent times during implant delivery.
[0012] Therefore, there is need for a non-surgical instrument and
method for subcutaneous implantation of sensors and solid materials
that preferably does not require an incision preparatory to
instrument insertion.
[0013] There is a further need for a subcutaneous implantation
instrument and method capable of implanting sensors and other solid
materials that are not readily disposed to implantation through a
substantially circular bore.
[0014] Moreover, there is a further need for a subcutaneous
implantation instrument and method which is minimally invasive,
preferably creating the smallest needed implantation site, and
capable of implantation without exposing the implant to
longitudinal stresses.
[0015] There is a still further need for an implantation instrument
that provides a progressive widening of an implantation site. Such
progressive widening would facilitate the use of wider-tipped
instruments that provide sufficient girth to admit implantable
sensors and medical devices with lowered patient trauma.
Preferably, such an instrument would include provision for
application of an anesthetic agent.
SUMMARY
[0016] An implantation instrument and method of use for implanting
sensors and other solid materials in a subcutaneous or other site
is provided. As used herein, "subcutaneous" refers generally to
those implantation sites located within a body below the skin. The
implantation instrument consists of an incising shaft attached to a
syringe body. The syringe body and incising shaft both define a
substantially non-circular hollow bore for accommodating the sensor
or solid material. The subcutaneous site is formed by a cutting
edge on the distal end of the incising shaft. The subcutaneous site
can be cleared using a clearing trocar slidably received within the
hollow bore. The sensor or solid material is advanced through the
hollow bore and delivered into the subcutaneous site. The depth of
the subcutaneous site can be limited using a penetration limiting
mechanism.
[0017] One embodiment provides a straight cutting tip for a full
large bore subcutaneous implantation instrument. An incising shaft
body defines an axial bore extending continuously throughout the
incising shaft body's length. The axial bore is open on both distal
and proximal ends of the incising shaft body and has a non-circular
cross section of at least five millimeters. A beveled surface is
transversely formed beginning on a top surface and ending on a
bottom surface of the incising shaft body. A cutting tip with a
pair of longitudinal straight cutting edges is formed on each side
and is progressively defined outwardly from the cutting tip to the
sides of the beveled surface at the bottom surface of the incising
shaft body. An attachment point is formed on the proximal end of
the incising shaft body.
[0018] A further embodiment provides a curved cutting tip for a
full large bore subcutaneous implantation instrument. An incising
shaft body defines an axial bore extending continuously throughout
the incising shaft body's length. The axial bore is open on both
distal and proximal ends of the incising shaft body and has a
non-circular cross section of at least five millimeters. A beveled
surface is transversely formed beginning on a top surface and
ending on a bottom surface of the incising shaft body. A cutting
tip with a pair of longitudinal curved cutting edges is formed on
each side and is progressively defined concave outwardly from the
cutting tip to the sides of the beveled surface at the bottom
surface of the incising shaft body. An attachment point is formed
on the proximal end of the incising shaft body.
[0019] A further embodiment provides a straight cutting tip for a
partial large bore subcutaneous implantation instrument. An
incising shaft body defines an axial bore extending part way
through the incising shaft body's length and a plunger bore
communicatively connected to the axial bore. The axial bore is open
on only a distal end of the incising shaft body and has a
non-circular cross section of at least five millimeters. The
plunger bore is open on only a proximal end of the incising shaft
body. A beveled surface is transversely formed beginning on a top
surface and ending on a bottom surface of the incising shaft body.
A cutting tip with a pair of longitudinal straight cutting edges is
formed on each side and is progressively defined outwardly from the
cutting tip to the sides of the beveled surface at the bottom
surface of the incising shaft body. An attachment point is formed
on the proximal end of the incising shaft body.
[0020] A further embodiment provides a curved cutting tip for a
partial large bore subcutaneous implantation instrument. An
incising shaft body defines an axial bore extending part way
through the incising shaft body's length and a plunger bore
communicatively connected to the axial bore. The axial bore is open
on only a distal end of the incising shaft body and has a
non-circular cross section of at least five millimeters. The
plunger bore is open on only a proximal end of the incising shaft
body. A beveled surface is transversely formed beginning on a top
surface and ending on a bottom surface of the incising shaft body.
A cutting tip with a pair of longitudinal curved cutting edges is
formed on each side and is progressively defined concave outwardly
from the cutting tip to the sides of the beveled surface at the
bottom surface of the incising shaft body. An attachment point is
formed on the proximal end of the incising shaft body.
[0021] A further embodiment provides an upwardly curved cutting tip
for a full large bore subcutaneous implantation instrument. An
incising shaft body concavely curved on a top surface in an arc of
approximately 20.degree. defines an axial bore extending
continuously throughout the incising shaft body's length. The axial
bore is open on both distal and proximal ends of the incising shaft
body and has a non-circular cross section of at least five
millimeters. A beveled surface is transversely formed beginning on
the top surface and ending on a bottom surface of the incising
shaft body. A cutting tip with a pair of longitudinal straight
cutting edges is formed on each side and progressively defined
outwardly from the cutting tip to the sides of the beveled surface
at the bottom surface of the incising shaft body. An attachment
point is formed on the proximal end of the incising shaft body.
[0022] A further embodiment provides A cutting tip for a large full
bore subcutaneous implantation instrument with penetration limiting
mechanism. An incising shaft body defines an axial bore extending
continuously throughout the incising shaft body's length. The axial
bore is open on both distal and proximal ends of the incising shaft
body and has a non-circular cross section of at least five
millimeters. A stopping flange is mounted on a bottom surface of
the incising shaft body at an angle of between approximately
30.degree. and 60.degree. bent in a proximal direction. A beveled
surface is transversely formed beginning on a top surface and
ending on the bottom surface of the incising shaft body. A cutting
tip with a pair of longitudinal straight cutting edges is formed on
each side and is progressively defined outwardly from the cutting
tip to the sides of the beveled surface at the bottom surface of
the incising shaft body. An attachment point is formed on the
proximal end of the incising shaft body.
[0023] A further embodiment provides a cutting tip for a polygonal
large bore subcutaneous implantation instrument. An incising shaft
body defines an axial bore extending continuously throughout the
incising shaft body's length. The axial bore is open on both distal
and proximal ends of the incising shaft body and has a cross
section in the shape of a simple closed polygon with a height of at
least five millimeters. A beveled surface is transversely formed
beginning on a top surface and ending on a bottom surface of the
incising shaft body. A cutting tip with a pair of longitudinal
straight cutting edges is formed on each side and is progressively
defined outwardly from the cutting tip to the sides of the beveled
surface at the bottom surface of the incising shaft body. An
attachment point is formed on the proximal end of the incising
shaft body.
[0024] One principal value of such a subcutaneous implantation
instrument and method would be to enable the subcutaneous insertion
of implantable objects and devices, such as sensors, without an
operating room or special procedures room. In essence, the
subcutaneous implantation instrument and method reduce insertion of
implantable objects and devices having non-conforming shapes to be
the functional equivalent of an injection.
[0025] Still other embodiments of the present invention will become
readily apparent to those skilled in the art from the following
detailed description, wherein is described embodiments of the
invention by way of illustrating the best mode contemplated for
carrying out the invention. As will be realized, the invention is
capable of other and different embodiments and its several details
are capable of modifications in various obvious respects, all
without departing from the spirit and the scope of the present
invention. Accordingly, the drawings and detailed description are
to be regarded as illustrative in nature and not as
restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] FIG. 1 is a perspective view of an instrument for implanting
sensors or solid materials in a subcutaneous or other tissue
location in accordance with the present invention;
[0027] FIG. 2A is a longitudinal cross-sectional view of the
implantation instrument with a straight incising shaft;
[0028] FIG. 2B is a longitudinal cross-sectional view of the
implantation instrument with a curved incising shaft;
[0029] FIG. 3 is a diagrammatic view illustrating the implantation
of an object into a subcutaneous site;
[0030] FIG. 4A is a diagrammatic view illustrating the clearing of
a subcutaneous site using the implantation instrument fitted with a
clearing trocar in accordance with a further embodiment;
[0031] FIG. 4B is a diagrammatic view illustrating the subcutaneous
implantation of an object using the implantation instrument fitted
with a pushing stylet in accordance with a further embodiment;
[0032] FIGS. 5A-D are transverse cross-sectional views of the
implantation instrument illustrating, by way of example, various
bore configurations;
[0033] FIG. 6 is a segmented side view of a clearing trocar;
[0034] FIG. 7 is a segmented side view of a pushing stylet; and
[0035] FIGS. 8A-8B are section views illustrating penetration
limiting mechanisms for use with the implantation instrument;
[0036] FIG. 9 is a perspective view of an instrument for implanting
objects in a subcutaneous or other tissue location in accordance
with a further embodiment of the present invention;
[0037] FIGS. 10A-10C are perspective views of cutting edges formed
on distal edges of incising shafts, in accordance with further
embodiments;
[0038] FIG. 11 is a longitudinal cross-sectional view of a
subcutaneous implantation instrument in accordance with a further
embodiment;
[0039] FIG. 12 is a top plan view of the subcutaneous implantation
instrument of FIG. 11;
[0040] FIGS. 13-15 are transverse cross-sectional views of the
dissecting tool assembly of FIG. 11;
[0041] FIG. 16 is a longitudinal cross-sectional view of a
subcutaneous implantation instrument in accordance with a still
further embodiment;
[0042] FIG. 17 is a top plan view of a subcutaneous implantation
instrument in accordance with an even further embodiment; and
[0043] FIGS. 18-20 are perspective diagrams showing a method of use
for the subcutaneous implantation instrument in accordance with one
embodiment.
DETAILED DESCRIPTION
[0044] FIG. 1 is a perspective view of an instrument 10 for
implanting objects in a subcutaneous or other tissue location in
accordance with the present invention. The implantation instrument
10 consists of two principal groups of components, an incising body
consisting of an incising shaft 11 and a syringe body 15, and a
delivery assembly consisting of a plunger assembly 20. The
instrument 10 can be used to non-surgically implant an object, such
as a sensor or monitor, medical therapeutic device, or other solid
or semi-solid object. The delivery assembly is received into the
syringe body bore by sliding the plunger assembly 20 through
proximal bore opening 19. An implantable object is received into
the syringe body bore. During an implant procedure, the implantable
object is deployed into the incising shaft and thence inserted
subcutaneously into an implantation site by progressive distal
urging of the plunger assembly 20, as further described below
beginning with reference to FIG. 18.
[0045] The incising shaft 11 is a hollow point chisel that is
formed with a beveled and rounded tip 12 that tapers into a
surgically sharp cutting edge 13 formed on a distal edge. The
beveled tip 12 includes a distal bore opening 14 through which the
implantable object is delivered into the implantation site.
[0046] The implantable object includes medical monitoring and
diagnostic devices, such as an implantable physiometry sensor, and
non-medical monitoring devices, such as an environmental or
activity monitor. Such sensors generally record data for subsequent
retrieval and can be autonomously triggered or triggered manually
by the implant recipient. One implantable sensor microchip suitable
for use in the present invention is described in PCT Publication
No. WO/2000/004945, to Habib et al., published Feb. 3, 2000, the
disclosure of which is incorporated by reference. Such a sensor
could be used for monitoring and collecting physiological or
chemical measures. A further implantable monitoring device suitable
for use is the Reveal insertable loop recorder, manufactured by
Medtronic, Inc., Minneapolis, Minn., which is an implantable heart
monitor for diagnosing the causes of syncope and other transient
heart symptoms involving rhythm-related disorders, as described in
U.S. Pat. No. 5,331,966, issued Jul. 26, 1994 to Bennett et al;
U.S. Pat. No. 6,230,059, issued May 8, 2001 to Duffin; and U.S.
Pat. No. 6,317,626, issued Nov. 13, 2001 to Warman, the disclosures
of which are incorporated by reference. Other medical monitoring
and diagnostic devices are possible.
[0047] The implantable object also includes non-sensor-type
implantable medical devices, including implantable medical devices
for therapeutic uses, such as administering cardiac pacing or
rhythm therapy; providing neural, muscle, or organ stimulation;
cancer treatment; and delivering or dosing medication. As well, the
present invention has equal applicability to implantation of other
types of non-medical sensors, including location and identification
sensors, such as radio frequency identification (RFID) tags. Such
sensors could include data transmitters with which to exchange
recorded data and instructional signals.
[0048] Finally, the implantable object can include solid or
semi-solid materials, such as a gelatinous drug bolus. In one
embodiment, the implantable object has approximate dimensions of 5
mm by 10 mm by 20 mm, although other dimensions can be equally
suitable. The critical dimension is the cross-sectional profile,
that is, the height and width, of the implant, which must conform
to passage through the syringe body and incising shaft bores. Other
non-linear, prismatic shapes are equally usable provided the
implantable object can fit within the confines of the syringe body
and incising shaft bores. The implant could also be folded or
compacted to minimize the cross-sectional profile with the implant
unfolding or expanding upon implantation. As well, the implant is
preferably protected against damage by encasement within, for
example, a mannitol pellet in the case of a solid drug delivery
system or epoxy in the case of an implantable sensor or medical
device. Other sizes, shapes, and types of non-liquid implantable
objects are possible.
[0049] The incising shaft 11 is fixably attached to the syringe
body 15 through frictional, adhesive, or preformed constructive
means, as is known in the art. Both the incising shaft 11 and
syringe body 15 define a substantially non-circular hollow bore
extending continuously along a shared longitudinal axis, as further
described below with reference to FIGS. 5A-D.
[0050] The plunger assembly includes a plunger 16, an
interconnecting plunger shaft 17 and a plunger end piece 18. The
plunger 16 is conformably shaped to fit within the syringe body
bore. The plunger end piece 18 facilitates deployment of the
plunger assembly through the syringe body bore and is preferably
shaped to fit a thumb or palm impression. In a further embodiment,
the non-circular hollow bore opens to the distal end of the
incising shaft 11 and extends only partly through to thereby form a
cavity, rather than a tube, but with provision for the sliding of
the plunger shaft 17.
[0051] In the described embodiment, the implantation instrument 10
is designed for inexpensive and disposable use utilizing low-cost,
sanitizable materials. The implantation instrument 10 can be used
for out-patient or non-surgical subcutaneous implant and insertion
of an implantable object, as further described below beginning with
reference to FIG. 18. The incising shaft 11 can be fashioned from
surgical grade stainless steel and has the approximate dimensions
of approximately 10 mm by 5 mm in cross section. The incising shaft
11 is approximately 50 mm long and the length can be varied to
accommodate different implantation depths. The plunger 16 is formed
from plastic and rubber and preferably forms a watertight seal
within the syringe body bore and has the approximate dimensions of
approximately 8 mm by 3 mm in cross section. The plunger shaft 17
and plunger end piece 18 are formed from plastic or similar
material. Other materials, as would be recognized by one skilled in
the art, could be substituted.
[0052] In a further embodiment, the syringe body 15 and plunger
assembly can be replaced by an automated injection system, such as
used with immunization injection guns or similar devices. These
devices typically employ compressed air or other inert gases to
administer medication in lieu of manual plungers. Other automated
variations include spring-loaded and similar mechanical injection
systems. The incising shaft 11 is fixably attached to the automated
injection system which functions as a delivery mechanism in place
of the syringe body 15 and plunger assembly. Thus, the implant
would be pushed through the incising shaft bore using the
compressed air or gas, or mechanical equivalent.
[0053] FIG. 2A is a longitudinal cross-sectional view of the
implantation instrument 10 with a straight incising shaft 11. The
hollow bore defined by both the incising shaft 11 and the syringe
body 15 runs along a common shared axis. The incising shaft bore 22
is sized to allow the implant to advance smoothly into the
implantation site under the forward lateral urging of the plunger
assembly 20. The syringe body bore 23 must be at least as large as
the incising shaft bore 22, but can be slightly larger to
accommodate lubricants, anesthetizing agents, or similar coatings,
such as mannitol, applied over the implantable object.
[0054] The syringe body 15 preferably includes a circular collar
21, pair of winglets, ears, or eyelets, or similar structure,
optionally formed on a proximal end of the syringe body 15 to
assist a user in depressing the plunger assembly 20.
[0055] FIG. 2B is a longitudinal cross-sectional view of the
implantation instrument with a curved incising shaft 24. The curved
incising shaft 24, as well as the syringe body 15 and related
components, are shaped into a substantially continuous curve along
the ventral side. The curvature helps regulate the penetration
depth of the incising shaft and, in the described embodiment, has
an arc of approximately 20 degrees.
[0056] FIG. 3 is a diagrammatic view illustrating the implantation
of an implantable object 28, including a sensor, implantable
medical device, such as an implantable cardioverter defibrillator,
pacemaker, or insertable loop recorder, or other solid material
into a subcutaneous site. Other implantable objects are possible.
During implantation, the incising shaft 11 is inserted through the
dermis 25 and guided into the layer of subcutaneous fat 26, above
the layer of muscle 27, to a subcutaneous implantation site. The
implantable object 28 is fed through the proximal bore opening 19
or received through the distal bore opening of the syringe body 15.
The implantable object 28 is then further advanced through the
syringe body bore 23 and the incising shaft bore 22 by the plunger
16 into the subcutaneous site. Note that although the foregoing
view illustrates an implant into the subcutaneous fat layer, one
skilled in the art would appreciate that subcutaneous implantation
locations are not strictly limited to the subcutaneous fat layer
and are generally termed as those implantation locations situated
subdurally within a body under the skin. Accordingly, subcutaneous
implantation sites further include locations that are intramuscular
and submuscular, or within a body cavity, including
intrathoracic.
[0057] FIG. 4A is a diagrammatic view illustrating the clearing of
a subcutaneous site using the implantation instrument 10 fitted
with a clearing trocar 29 in accordance with a further embodiment.
The clearing trocar 29, as further described below with reference
to FIG. 6, is mounted to its own handle or plunger assembly and has
a sharp cutting tip 30 for optionally clearing a subcutaneous site
prior to delivery of the implant.
[0058] Prior to implantation, the clearing trocar 29 is slidably
received into the syringe body 15 and is advanced until the cutting
tip 30 is even with the proximal bore opening 19 of the incising
shaft 11. During operation, the incising shaft 11 and clearing
trocar 29 are inserted through the dermis 25 and guided into the
layer of subcutaneous fat 26, above the layer of muscle 27.
[0059] The cutting edge 13 of the beveled tip 12 makes an entry
incision through the dermis 25 and is laterally pushed into the
subcutaneous fat 26 until the cutting edge 13 is adjacent to the
subcutaneous site. The clearing trocar 29 is then urged through the
subcutaneous fat 26 by advancement of its handle or plunger
assembly to prepare the implantation site for delivery of the
implantable object 28, including an implantable sensor, medical
device, or other solid material. The clearing trocar 29 is then
withdrawn from the subcutaneous site and out of the implantation
instrument 10.
[0060] FIG. 4B is a diagrammatic view illustrating the subcutaneous
implantation of an implantable object 28 using the implantation
instrument 10 fitted with a pushing stylet 31 in accordance with a
further embodiment. The pushing stylet 31, as further described
below with reference to FIG. 7, has a blunt tip 32 for advancing
the implantable object 28 through the syringe body bore 23 and
incising shaft bore 22 and into the subcutaneous site. The cross
section of the pushing stylet 31 closely conforms to the incising
shaft bore 22 while the plunger 16 closely conforms to the syringe
body bore 23. The pushing stylet 31 thus extends the reach of the
plunger assembly 20 and allows the syringe body bore 23 to have a
different cross-section than the incising shaft bore 22.
[0061] The pushing stylet 31 is used while the incising shaft 11 is
in situ in the subcutaneous layer 26. Prior to delivery, the
implantable object 28 is fed through the proximal bore opening 19
of the syringe body 15 and further advanced within the syringe body
bore 23 by contact with the plunger 16. The pushing stylet 31 is
slidably received into the syringe body 15 and is advanced until
the blunt tip 32 contacts the implantable object 28. During
operation, the implantable object 28 is urged through the incising
shaft bore 22 by the pushing stylet 31 and into the subcutaneous
site by advancement of the plunger assembly. Upon delivery of the
implantable object 28 into the subcutaneous site, the incising
shaft 11 and pushing stylet 31 are withdrawn.
[0062] Although operation of the implantation instrument 10 is
described with reference to the implantation of sensors or solid
materials into a subcutaneous site situated within the layer of
subcutaneous fat 26, implantations could also be effected in other
subcutaneous, intramuscular, intraperitoneal, intrathoracic,
intracranial, intra joint, as well as other organ or
non-subcutaneous sites, as would be recognized by one skilled in
the art. In addition, the foregoing procedure could be modified to
forego the use of the clearing trocar 29 for small implantable
objects 28. The clearing effect of the clearing trocar 29 can be
approximated by use of the incising shaft 11 alone whereby the
incising shaft 11 is inserted into the subcutaneous site and then
withdrawn by reverse deployment, thereby forming a slightly
overwide implantation site.
[0063] The operations of subcutaneous implantation can be carried
out over a plurality of sites and with the same or different
implantable objects 28. Similarly, several implantable object 28
could be implanted at the same subcutaneous site during a single
implantation operation.
[0064] FIGS. 5A-D are transverse cross-sectional views of the
implantation instrument 10 illustrating, by way of example, various
bore configurations. FIG. 5A illustrates an incising shaft 35 with
a substantially rectangular bore 36. FIG. 5B illustrates an
incising shaft 37 with a substantially square bore 38. FIG. 5C
illustrates an incising shaft 39 with a substantially oval bore 40.
And FIG. 5D illustrates an incising shaft 41 with a substantially
hexagonal bore 42. Note the circumferential shape of the incising
shaft need not follow the internal shape of the incising shaft
bore. Other bore configurations, including variations on oval,
rectangular, square, pentagonal, hexagonal, heptagonal, octagonal,
and similar equilateral or non-equilateral shapes, are
feasible.
[0065] In the described embodiment, the rectangular bore 36 has the
dimensions of approximately 10 mm by 5 mm. The syringe body bore 23
has a length of approximately 5 cm.
[0066] FIG. 6 is a segmented side view of a clearing trocar 45. The
clearing trocar 45 consists of a beveled tip 47 on the distal end
of the clearing trocar 45 and a clearing trocar shaft 46 affixed,
either fixably or removably, to the distal end of a plunger 16.
[0067] During a clearing operation, the clearing trocar 45 is fully
extended from the distal bore opening 14 of the incising shaft 11.
The clearing trocar shaft 46 is only long enough to clear out the
subcutaneous site. The plunger 16 acts as a stop that limits the
extent of penetration of the clearing trocar 45, thereby preventing
the clearing trocar 29 from incising too deeply into the
subcutaneous fat 29. In addition, the clearing trocar 29 is sized
to approximate the girth of the incising shaft bore 22 and will
clear a subcutaneous site only as wide as minimally necessary to
facilitate implantation of the implantable object. In the described
embodiment, the clearing trocar 45 has a length of approximately 2
cm beyond the tip of the syringe body 15.
[0068] FIG. 7 is a segmented side view of a pushing stylet 50. The
pushing stylet 50 consists of a blunt tip 52 on the distal end of
the pushing stylet 50 and a pushing stylet shaft 51 affixed, either
fixably or removably, to the distal end of a plunger 16.
[0069] During a delivery operation, the pushing stylet 50 is
extended from the distal bore opening 14 of the incising shaft 11.
The pushing stylet shaft 51 is only long enough to clear the distal
bore opening 14. The plunger 16 acts as a stop that limits the
lateral travel of the pushing stylet 50. In the described
embodiment, the pushing stylet 50 has an additional length of
approximately 2 cm beyond the tip of the syringe body 15.
[0070] FIGS. 8A-8B are section views illustrating penetration
limiting mechanisms for use with the implantation instrument 10.
The penetration limiting mechanisms limit the depth of penetration
of the incising shaft 11 and help prevent excessive penetration.
FIG. 8A shows a fixed penetration limiting mechanism consisting of
a stopping flange 55 attached to the incising shaft 11. The
position of the stopping flange 55 along the incising shaft 11 can
be adjusted by loosening a hold-down screw 58 and sliding the
stopping flange 55 into the desired location. The lower edge of the
stopping flange 55 has a bend 57 with an angle .tau., preferably
between approximately 30.degree. and 60.degree., thereby forming an
elbow 56 which stops lateral travel upon contact with the skin.
[0071] FIG. 8B shows an adjustable penetration limiting mechanism
consisting of a stopping flange 60 attached a frictional collar 64.
The stopping flange 60 and frictional collar 64 are slidably
attached to the incising shaft 11. An adjustable collar 64,
preferably in threaded communication 65 with the frictional collar
64, manually stops deployment of the penetration limiting mechanism
by tightening the frictional collar 64 against the incising shaft
11. The lower edge of the stopping flange 60 has a bend 62 with an
angle .upsilon., preferably between approximately 30.degree. and
60.degree., thereby forming an elbow 61 which stops lateral travel
upon contact with the skin.
[0072] FIG. 9 is a perspective view of an instrument for implanting
objects in a subcutaneous or other tissue location in accordance
with a further embodiment of the present invention. The instrument
is equipped with the stopping flange 55 shown in FIG. 8A. Other
forms of penetration limiting mechanisms, both fixed and
adjustable, could be used, as would be readily apparent to one
skilled in the art.
[0073] In addition to being flat and chisel-like, the cutting edge
of the incising shaft can be shaped as a progressive cutting or
clearing blade, or a dissecting tool suitable for use in
facilitating subcutaneous insertion. FIGS. 10A-10C are perspective
views of progressive cutting edges 71, 81, 91 formed on distal
edges of incising shafts 70, 80, 90 in accordance with further
embodiments. The cutting edge can be shaped to facilitate
subcutaneous insertion, such as when necessary to penetrate areas
of thick epidermis, for instance, on the hands or feet, or animal
hide. For instance, the cutting edge 71 can be shaped into a point
or semi-point, which can initially pierce and progressively enlarge
an implantation site. Similarly, the cutting edge 81 can be shaped
into a rounded or curved edge, which can also progressively enlarge
an implantation site, but without initial piercing. In addition,
the cutting edge 91 upwardly curved or angled, which can help shape
the implantation site to more closely follow the contours of the
object to be implanted. Other cutting edge shapes are possible.
Moreover, dissecting tools could be used in addition to or in lieu
of the progressive cutting edges, such as a flat or shaped
dissecting tool.
[0074] FIG. 11 is a longitudinal cross-sectional view of a
subcutaneous implantation instrument 100 in accordance with a
further embodiment. A dissecting tool assembly 101 is removably
affixed to the distal end of the incising shaft 11 with a coupling
sheath 103, which can be constructed as an over sleeve frictionally
fit over the incising shaft 11, a snap-off assembly that detaches
from the incising shaft 11 by twisting or distal movement, or some
other type of coupling that is non-integral to the incising shaft
11. The dissecting tool assembly 101 includes a needle tip 102 that
defines a lumen that internally interfaces to the bore opening 14
of the incising shaft 11 and which can be used to inject a local
anesthetic agent or other liquid or semi-liquid substance into the
implantation site. The needle tip 102 also progressively defines a
pair of cutting blades along each outward facing edge.
[0075] FIG. 12 is a top plan view of the subcutaneous implantation
instrument 100 of FIG. 11. The cutting blades are oriented
longitudinally and planar to the cutting edge 13 of the incising
shaft 11. The cutting blades provide cutting edges 105, which
gradually increase the width of the incision made when the
implantation instrument 100 is inserted subcutaneously. The cutting
edges 105 can be straight, concave, convex, or a combination
thereof.
[0076] FIGS. 13-15 are transverse cross-sectional views of the
dissecting tool assembly 101 of FIG. 11. On a distal end, the
needle tip 102 internally defines a lumen of approximately 16
French, which tapers outwardly to a larger diameter bore and
substantially non-circular bore of approximately 30 gauge on the
proximal end. The cutting edges 105 become increasingly pronounced
towards the proximal end of the needle tip 102. Other lumen, bore
sizes, and cutting edge arrangements are possible.
[0077] FIG. 16 is a longitudinal cross-sectional view of a
subcutaneous implantation instrument 110 in accordance with a still
further embodiment. A curved dissecting tool assembly 111 bends in
a gradual arc 112 upwardly towards the incising blade 11 to
facilitate implantation. The curved dissecting tool assembly 111
can be used with either the straight incising shaft 11 or curved
incising shaft 24. The curvature enables the implantable object to
be more easily oriented parallel to the surface of the skin, rather
than at an angle.
[0078] FIG. 17 is a top plan view of a subcutaneous implantation
instrument 121 in accordance with an even further embodiment. A
scissored dissecting tool assembly 122 is divided into two halves,
which are each attached to a handle 123 that is pivotably mounted
124, in the manner of a pair of scissors. The handles 123 can be
operated outwardly to cause the distal end of the scissored
dissecting tool assembly 122 to open and longitudinally cut into
the surrounding tissues, thereby widening the implantation site.
Once the implantation site has been suitably cleared, the scissored
dissecting tool assembly 122 remains open and the plunger assembly
20 is progressive urged distally to insert the implantable object.
The scissored dissecting tool assembly 122 can be straight or
curved to facilitate implantation. Other forms of scissored
dissecting tool assemblies are possible.
[0079] FIGS. 18-20 are perspective diagrams showing a method of use
for the subcutaneous implantation instrument 121 in accordance with
one embodiment. Referring first to FIG. 18, the subcutaneous
implantation instrument 130 can be used for out-patient or
non-surgical subcutaneous insertion of an implantable object, such
as an implantable sensor, medical device, or solid material. The
implantation instrument 10 enables the subcutaneous insertion of
implantable objects and devices, such as sensors, without an
operating room or special procedures room. The implantation
instrument 10 reduce insertion of implantable objects and devices
having non-conforming shapes to be the functional equivalent of an
injection.
[0080] The subcutaneous implantation instrument 130 can be sold or
marketed as part of a package that combines an implantable object
134 with the subcutaneous implantation instrument 130, particularly
where the subcutaneous implantation instrument 130 is provided as a
single-use disposable unit. Thus, the subcutaneous implantation
instrument 130 can be offered with an implantable 134 object
already disposed within the syringe body 131, with the entire
package sealed ready for use inside sterile packaging (not shown).
Alternatively, the subcutaneous implantation instrument 130 can be
offered in combination with an implantable object 134 that is
packaged separately.
[0081] At the outset of the procedure, an implantation site 137 can
be locally anesthetized using the subcutaneous implantation
instrument 130 by fitting the incising shaft 132 with a dissecting
tool assembly 136, as provided in a further embodiment, described
above with reference to FIG. 11 et seq. The coupling sheath 103 of
the dissecting tool assembly 136 removably fits over the distal end
of the incising shaft 132. The implantation site 137 is cleaned and
sterilized and the needle tip 102 is inserted subcutaneously. The
needle tip 102 and cutting blades on the dissecting tool assembly
136 form a progressively larger opening as the subcutaneous
implantation instrument 130 is pressed downward through the skin.
The plunger assembly 133 is then pressed distally to inject a local
anesthetic agent into the subcutaneous implantation site.
[0082] Referring next to FIG. 19, the dissecting tool assembly 136
is withdrawn from the implantation site 137 and removed from the
incising shaft 132, thereby exposing the cutting edge of the
incising shaft 132. The bare incising shaft 132 is inserted into
the previously cleared implantation site 137 and pressed downward.
Depending upon the configuration of the cutting edges 105 of the
dissecting tool assembly 136, the cutting edge of the incising
shaft 132 may only need to enlarge the opening, rather than
clearing a full width opening.
[0083] Referring finally to FIG. 20, downward movement of the
subcutaneous implantation instrument 130 is stopped when the
appropriate depth for implantation has been reached and, if
necessary, is urged slight back to clear the incising shaft 137
from the actual subcutaneous implantation site. The plunger
assembly 133 is again pressed distally to deploy the implantable
object 134 into the incising shaft 134 and thence to insert the
implantable object 134 into the subcutaneous implantation site. The
incising shaft 132 is withdrawn and the wound is appropriately
dressed to complete the implantation procedure. Through use of the
method, the subcutaneous sensor insertion of implantable objects
and devices, such as sensors, having non-conforming shapes is
thereby reduced to be the functional equivalent of an
injection.
[0084] While the invention has been particularly shown and
described as referenced to the embodiments thereof, those skilled
in the art will understand that the foregoing and other changes in
form and detail may be made therein without departing from the
spirit and scope of the invention.
* * * * *
References