U.S. patent application number 10/098336 was filed with the patent office on 2002-08-08 for package for removable device tips.
Invention is credited to Crocetta, Michael J. JR., Johnson, Wayne, Shapeton, Mark.
Application Number | 20020104770 10/098336 |
Document ID | / |
Family ID | 24848804 |
Filed Date | 2002-08-08 |
United States Patent
Application |
20020104770 |
Kind Code |
A1 |
Shapeton, Mark ; et
al. |
August 8, 2002 |
Package for removable device tips
Abstract
A package for a tip, such as a replaceable tip for a bipolar
electrosurgical device, is used for insertion of the tip onto and
removal of the tip from the end of a device handle, without
requiring any direct contact between the user's hand and the tip.
The package includes a housing having a tip cavity shaped to
receive the tip and an opening through which the end of the handle
is insertable for removable attachment to the tip. A releasable
locking mechanism, which is releasable in response to the end of
the handle being disposed in the opening for removable attachment
to the tip, retains the tip in the tip cavity. The package may be
made from a single piece of molded material, such as a clear
plastic. The package may also be used with monopolar, diathermized
and non-bipolar tips, as well as other sharp tips such as cannulae,
pics and blades, that are attachable to the end of a handle.
Inventors: |
Shapeton, Mark; (Chestnut
Hill, MA) ; Johnson, Wayne; (Whitman, MA) ;
Crocetta, Michael J. JR.; (Santa Barbara, CA) |
Correspondence
Address: |
Robert H. Epstein
Epstein, Edell, Shapiro, Finnan & Lytle, LLC
Suite 400
1901 Research Blvd.
Rockville
MD
20850
US
|
Family ID: |
24848804 |
Appl. No.: |
10/098336 |
Filed: |
March 18, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10098336 |
Mar 18, 2002 |
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09661895 |
Sep 14, 2000 |
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6358241 |
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09661895 |
Sep 14, 2000 |
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09126699 |
Jul 30, 1998 |
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6183467 |
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09126699 |
Jul 30, 1998 |
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08709181 |
Sep 6, 1996 |
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5814043 |
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Current U.S.
Class: |
206/363 ;
206/365; 30/329; 606/1; 606/45 |
Current CPC
Class: |
A61B 2018/00178
20130101; A61B 18/1402 20130101; A61B 2018/00988 20130101; A61B
18/14 20130101 |
Class at
Publication: |
206/363 ; 606/1;
606/45; 30/329; 206/365 |
International
Class: |
A61B 017/00; B65D
083/10 |
Claims
1. A package for a tip of a surgical device capable of removable
attachment to an end of a handle, comprising a housing having a tip
cavity shaped to receive the tip and an opening through which the
end of the handle is insertable for removable attachment to the
tip.
2. The package of claim 1 further comprising a releasable locking
mechanism for retaining the tip in the tip cavity, the locking
mechanism being released in response to the end of the handle being
disposed in the opening for removable attachment to the tip.
3. The package of claim 2 wherein the releasable locking mechanism
is a movable protrusion of an inner surface of the housing which
forms the cavity, the releasable locking mechanism being movable by
the end of the handle to release the tip.
4. The package of claim 1 wherein the housing is made from a single
piece of molded material.
5. The package of claim 4 wherein the material is plastic.
6. The package of claim 4 wherein the material is co-polyester
PETG.
7. The package of claim 4 wherein the material is polyvinyl
chloride.
8. The package of claim 4 wherein the housing is made by vacuum
molding.
9. The package of claim 4 wherein the material is clear.
10. A package for a tip of a surgical device capable of removable
attachment to an end of a handle, comprising a top portion, a
bottom portion, and a hinging segment connecting the top portion
and the bottom portion, the top portion and the bottom portion
forming a tip cavity when the top portion and the bottom portion
are folded together along the hinging segment, the tip cavity being
shaped to receive the tip and having an opening through which the
end of the handle is insertable for removable attachment to the
tip.
11. The package of claim 10 further comprising a releasable locking
mechanism comprising a releasable locking recess formed in the top
portion and the bottom portion to hold the tip within the tip
cavity, the locking mechanism releasable in response to the end of
the handle being disposed in the opening for removable attachment
to the tip.
12. The package of claim 11 wherein the end of the handle has a
bevel and wherein the locking mechanism further comprises a ramp
disposed adjacent to the locking recess such that the bevel
contacts the ramp to release the locking mechanism.
13. The package of claim 10 wherein the tip includes a protrusion
and wherein the top portion includes a positioning cavity shaped to
receive the protrusion, the positioning cavity preventing the tip
from rotating within the tip cavity.
14. The package of claim 10 wherein the package is made from a
single piece of molded plastic material.
15. The package of claim 14 wherein the top portion includes a
molded pocket and the bottom portion includes a molded boss, the
boss engaging the pocket to hold the top portion and the bottom
portion together when folded along the hinging segment.
16. The package of claim 14 wherein the top portion arid the bottom
portion include interlocking ribs.
17. The package of claim 14 wherein the top portion includes a
molded placement indicator to indicate placement of a user's
fingers.
18. The package of claim 14 wherein the top portion includes a
molded directional indicator to indicate a direction of movement of
the handle in the tip cavity.
19. A method of attachably engaging a tip of a surgical device to
an end of a handle, comprising providing a tip being releasably
retained in a package having an opening; inserting the end of the
handle into the opening to release the tip retained in the package;
pushing the end of the handle inserted into the opening to
attachably engage the tip to the end of the handle; and withdrawing
the end of the handle from the opening with the attachably engaged
tip.
20. The method of claim 19 further comprising applying pressure to
the package prior to the pushing step; and releasing the pressure
on the package prior to the withdrawing step.
21. A method of releasing a tip of a surgical device that is
removably attached to an end of a handle, comprising providing a
package having an opening; inserting the end of the handle with the
removably attached tip into the opening; pushing the end of the
handle inserted into the opening until the tip is released and
retained in the package; and withdrawing the end of the handle from
the opening.
22. The method of claim 21 further comprising applying pressure to
the package prior to the withdrawing step.
23. A surgical product, comprising a tip capable of removable
attachment to an end of a handle, and a housing having a tip cavity
in which said tip is disposed, said housing having an opening
through which the end of the handle is insertable for removable
attachment to the tip.
24. The product of claim 23 further comprising a releasable locking
mechanism for retaining the tip in the tip cavity, the locking
mechanism being released in response to the end of the handle being
disposed in the opening for removable attachment to the tip.
25. The product of claim 23 wherein the tip is a bipolar tip of the
kind used with a bipolar electrosurgical device.
26. The product of claim 23 wherein the tip is a sharp tip.
27. A surgical product, comprising a replaceable tip attachable to
a handle having an opening and a plurality of coaxial, axially
spaced electrical contacts therein, the tip comprising a tip
housing having a proximal end and a distal end, the proximal end of
the tip housing configured to be received within the opening of the
handle, a plurality of electrodes disposed through the tip housing,
the electrodes having distal ends that extend distally from the
distal end of the tip housing and proximal ends that are coaxial
and axially spaced from each other and that extend proximally from
the proximal end of the tip housing for connection to the coaxial,
axially spaced electrical contacts of the handle when the proximal
end of the tip housing is inserted in the opening of the handle,
the proximal end of the tip housing being constructed to be
releasably secured to the handle for operation of the surgical
device solely by inserting the proximal end of the tip housing
axially into the opening of the handle; and a housing having a tip
cavity in which the tip is disposed, said housing having an opening
through which the end of the handle is insertable for removable
attachment to the tip.
28. The product of claim 27 wherein the tip housing is configured
to provide a snap fit with the handle.
Description
[0001] This is a continuation-in-part of application Ser. No.
08/709,181, filed Sep. 6, 1996 (the "parent application").
BACKGROUND OF THE INVENTION
[0002] This invention relates to packages for surgical devices, and
particularly to packages for removable tips of such devices.
[0003] Examples of surgical devices with removable tips include
electrosurgical devices, such as monopolar cauterization devices
and diathermy devices. Other types of removable tips are sharp tips
(e.g., needles, pics, and blades) that are attached to the end of a
handle.
SUMMARY OF THE INVENTION
[0004] This invention features a package for a surgical device tip
which may be used for insertion of the tip onto and removal of the
tip from the handle of the surgical device, without requiring any
direct contact between the user's hand and the tip.
[0005] In one general aspect of the invention, a package for a tip
of a surgical device capable of removable attachment to an end of a
handle includes a housing having a tip cavity shaped to receive the
tip and an opening through which the end of the handle is
insertable for removable attachment to the tip. Related aspects of
the invention feature the combination of the package and a tip
disposed in the package, and methods of using the package to attach
the tip onto, and detach the tip from, the handle.
[0006] Preferred embodiments may include one or more of the
following features.
[0007] A releasable locking mechanism, which is released in
response to the end of the handle being disposed in the opening for
removable attachment to the tip, retains the tip in the tip cavity.
The releasable locking mechanism is a movable protrusion of an
inner surface of the housing which forms the cavity, and is movable
by the end of the handle to release the tip.
[0008] The package is made from a single piece of molded material,
which may be a clear plastic material such as co-polyester PETG or
polyvinyl chloride. The package is made by molding, such as vacuum
molding.
[0009] In another general aspect of the invention, the package
includes a top portion, a bottom portion, and a hinging segment
connecting the top portion and the bottom portion. The top portion
and the bottom portion form a tip cavity when the top portion and
the bottom portion are folded together along the hinging segment.
The tip cavity is shaped to receive the tip and has an opening
through which the end of the handle is insertable for removable
attachment to the tip.
[0010] Preferred embodiments may also include one or more of the
following features.
[0011] A releasable locking mechanism, including a releasable
locking recess formed in the top portion and the bottom portion,
holds the tip within the tip cavity. The locking mechanism is
releasable in response to the end of the handle being disposed in
the opening for removable attachment to the tip.
[0012] The tip includes a protrusion, and the top portion includes
a positioning cavity shaped to receive the protrusion to prevent
the tip from rotating within the tip cavity. The end of the handle
has a bevel, and the locking mechanism has a ramp disposed adjacent
to the locking recess so that the bevel contacts the ramp to
release the locking mechanism.
[0013] The top and bottom portions include several molded features.
For example, the top portion includes a molded packet and the
bottom portion includes a molded boss, the boss engaging the pocket
to hold the top portion and the bottom portion together when folded
along the hinging segment. The top and bottom portions also include
interlocking ribs. The top portion includes a molded placement
indicator to indicate placement of a user's fingers, and a molded
directional indicator to indicate a direction of movement of the
handle in the tip cavity.
[0014] In use, a tip disposed within the package is attached to the
end of a handle by inserting the end of the handle into the package
opening to release the tip, pushing the end of the handle inserted
into the opening to attachably engage the tip to the end of the
handle, and withdrawing the end of the handle from the opening with
the attachably engaged tip. Similarly, the tip is detached from the
handle and stored in the package by inserting the end of the handle
with the removably attached tip into the package opening, pushing
the end of the handle inserted into the opening until the tip is
released and retained in the package, and withdrawing the end of
the handle from the opening. Pressure may be applied to and
released from the package to assist in the attachment of the tip
onto and the removal of the tip from the handle.
[0015] The invention is particularly well-suited, but by no means
limited, for use with bipolar electrosurgical devices with
removable bipolar tips which can be easily and conveniently
detached from the handle, such as the devices disclosed in the
parent application.
[0016] Thus, in one embodiment, the tip is attachable to a handle
having an opening and a plurality of coaxial, axially spaced
electrical contacts. The tip includes a tip housing having a
proximal end and a distal end, the proximal end of the tip housing
configured to be received within the opening of the handle. A
plurality of electrodes are disposed through the tip housing, the
electrodes having distal ends that extend distally from the distal
end of the tip housing and proximal ends that are coaxial and
axially spaced from each other and that extend proximally from the
proximal end of the tip housing for connection to the coaxial,
axially spaced electrical contacts of the handle when the proximal
end of the tip housing is inserted in the opening of the handle.
The proximal end of the tip housing is constructed to be releasably
secured to the handle (e.g., by a snap fit) for operation of the
surgical device solely by inserting the proximal end of the tip
housing axially into the opening of the handle. The package has a
tip cavity shaped to receive the tip. In an alternative embodiment,
the tip is a sharp tip.
[0017] In use, the user simply selects a packaged tip from an
inventory of such tips, and installs the tip onto the device handle
in the manner described above. The device is then ready for use in
surgery. After it is used, the tip is removed from the handle and
stored in the package, using the procedure described above, and
discarded or stored for subsequent use during the same surgical
procedure. If desired, another packaged tip may be selected,
inserted onto the handle, and used to perform a different treatment
(e.g., cauterization) during the same surgical procedure.
[0018] The package securely retains and protects each tip, thereby
eliminating several safety and sterility concerns that accompany
the use of removable surgical tips. Among other advantages, the
package eliminates the need for the user's hand to contact the tips
during either installation or removal of the tips. Use of the
package prevents contamination or exposure by the user to used
tips. Further, tips delivered in sterile packages can be attached
to the handle without risking contamination from the user's
hands.
[0019] The package allows for simple insertion of tips onto and
removal of tips from the handle of the surgical device. The package
may be shaped to accommodate various types of tips used with the
handle. The package, which may permit the user to see the tip
inside, allows for efficient organization of tips during a surgical
procedure.
[0020] The package also protects the user from the sharp ends of
the tips' electrodes. The interlocking ribs of the top and bottom
portions and the hinging segment help to avoid accidental release
of the tip retained in the package and to prevent the sharp end of
the tip electrode from sliding out through the sides of the
package. Also, the electrical contacts of the tip electrodes that
attach to the handle are recessed in the opening of the housing to
avoid accidental contact with the user's hands.
[0021] Other features and advantages of the invention will become
apparent from the following description and from the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] FIG. 1 is a perspective view of a surgical device with a tip
of the device separated from a handle, and the handle partially cut
away.
[0023] FIG. 2 is a side, partially cross-sectioned view of the tip
and handle of FIG. 1.
[0024] FIG. 3 is a perspective view of the surgical device of FIG.
1 with the tip inserted in the handle.
[0025] FIG. 4 is a side, partially cross-sectioned view of the
device of FIG. 3.
[0026] FIG. 5 is an enlarged view of the tip and handle of FIG.
1.
[0027] FIGS. 6A-6E show a variety of tips for use with the handle
of FIG. 1.
[0028] FIG. 7 is a schematic representation of the surgical device
of FIG. 1 in use.
[0029] FIG. 8 shows another embodiment of a surgical device and
removable tip.
[0030] FIG. 9 is a top plan view of a package for a removable tip
of a surgical device in an unfolded state.
[0031] FIG. 10 is a side view of the package of FIG. 9 in an
unfolded state.
[0032] FIG. 11 is a side, partially cross-sectioned view of the
package of FIG. 9, as folded, positioned to receive the surgical
device including the tip inserted onto the handle.
[0033] FIG. 12 is a side, partially cross-sectioned view of the
package of FIG. 9, as folded, receiving the tip of the surgical
device inserted onto the handle.
[0034] FIG. 13 is a side, partially cross-sectioned view of the
package of FIG. 9, as folded, retaining the tip of the surgical
device which has been removed from the handle.
[0035] FIG. 14 is a perspective view of the package of FIG. 9, as
folded.
[0036] FIG. 15 is a top plan view of the package of FIG. 14.
[0037] FIG. 16 is a bottom plan view of the package of FIG. 14.
[0038] FIG. 17 is an elevational view of one side of the package of
FIG. 14.
[0039] FIG. 18 is an elevational view of the other side of the
package of FIG. 14.
[0040] FIG. 19 is a front elevational view of the package of FIG.
14.
[0041] FIG. 20 is a rear elevational view of the package of FIG.
14.
[0042] FIG. 21 is a perspective view of the package of FIG. 9, as
folded, including the tip.
[0043] FIG. 22 is a top plan view of the tip and package of FIG.
21.
[0044] FIG. 23 is a bottom plan view of the tip; and package of
FIG. 21.
[0045] FIG. 24 is an elevational view of one side of the tip and
package of FIG. 21.
[0046] FIG. 25 is an elevational view of the other side of the tip
and package of FIG. 21.
[0047] FIG. 26 is a front elevational view of the tip and package
of FIG. 21.
[0048] FIG. 27 is a rear elevational view of the tip and package of
FIG. 21.
DESCRIPTION OF PREFERRED EMBODIMENTS
[0049] Before describing the package of the present invention, it
would be helpful to describe one kind of surgical instrument with
which the package may be used. Referring to FIGS. 1 and 2, a
surgical device 10 has a reusable handle 12 with a removable tip
14. In use, tip 14 is inserted into handle 12 as shown in FIGS. 3
and 4. After use, tip 14 is removed from handle 12, discarded, and
a new tip is inserted into handle 12.
[0050] Tip 14 comprises a solid, cylindrical inner electrode 16
disposed coaxially inside a hollow, cylindrical cuter electrode 18.
Electrodes 16, 18 are closely spaced and separated by a thin
coaxial insulator 20. Alternatively, tip 14 may be made by coating
outer electrode 18 onto an insulated inner electrode 16, as
described in the copending patent application of Harry Reimels et
al. entitled "Bipolar Electrosurgical Instrument and Method for
Making the Same," filed Jan. 26, 1996 as Ser. No. 63/591,953,
assigned to the present assignee and incorporated herein by
reference.
[0051] A distal treatment end 22 of the electrodes includes a flat
surface 24 that is applied to tissue during surgery. A proximal
connection end 25 of the electrodes is configured for connection to
handle 12. Electrodes 16, 18 form a substantially straight line
from connection end 25 to treatment end 22.
[0052] At connection end 25, a proximal end 17 of inner electrode
16 is axially displaced from a proximal end 19 of outer electrode
18. A proximal end 21 of insulator 20 is disposed intermediate the
proximal ends 17, 19 of electrodes 16, 18. As a result, a length
(a) of electrode 18, a length (b) of insulator 20 and a length (c)
of electrode 16 are exposed (FIG. 2).
[0053] Handle 12 includes an opening 56 at one end. The end of
handle 12 also has a sloped bevel 57, the width of which increases
as the distance to opening 56 increases. Two cylindrical electrical
contacts 74, 76 separated by cylindrical receptacle 78 are arranged
coaxially in opening 56. Contact 74 has one end 82 abutting an end
of receptacle 78. Another end of receptacle 78 is adjacent to an
end of contact 76. Contact 76 has a smaller radius than contact 74,
and receptacle 78 has a radius intermediate those of contacts 74,
76.
[0054] The length of contact 74 matches the combined lengths of
outer electrode 18 and insulator 20 at connection end 25 (i.e.
length a +length b in FIG. 2). The length of receptacle 78 and
contact 76 together equal the length (c) of electrode 16 exposed at
tip end 25.
[0055] A ring-like conductor 75, 77 is disposed on the inside
surface of each electrical contact 74, 76. The inner diameter of
conductors 75, 77 is only slightly larger than the diameter of
electrodes 18, 16, respectively. In addition, each contact 74, 76
is connected by a wire 84, 86 to a connector pin 88, 90 at a
proximal end of handle 12. Pins 88, 90 are adapted for connection
to a high frequency power source.
[0056] Tip 14 also includes a plastic housing 28 mounted around the
exterior of electrode 18. Treatment end 22 and connection end 25 of
electrodes 16, 18 extend distally and proximally, respectively,
from housing 28. The distal end of housing 28 is conically shaped
and has a sloping, grooved exterior surface 30. A proximal end of
housing 14 comprises a conical section 32 that terminates in a
cylindrically-shaped nose 34. The shape of handle opening 56 is
complementary to that of the proximal end of housing 28 so that
housing 28 snugly mates with handle 12. Thus, the distal end of
opening 56 includes a conically-shaped inner surface 70 that meets
a cylindrically-shaped inner surface 72.
[0057] Handle 12 is formed as a cylindrical body 50 (made from,
e.g. metal or composite material) with a distal section 54 that is
threaded onto a proximal section 55. Opening 56 is disposed in
distal section 54, while proximal section 55 includes the
electrical contacts 74, 76, receptacle 78, wires 82, 86 and pins
88, 90. A series of grooves 52 is formed in the exterior surface of
proximal section 55 to define a set of raised circumferential ribs
53 that assist the user in gripping the device.
[0058] Referring also to FIG. 5, tip 14 includes a protrusion 38
extending from grooved surface 30 to an edge of tapered section 32,
at a predetermined radial position with respect to electrodes 16,
18. Protrusion 38 has an axially-extending rectangular tab 40 that
terminates proximally in a round button 42. The diameter of button
42 is slightly larger than the width of tab 40.
[0059] Distal end 54 of handle 14 includes an axially-extending,
tapered slot 58 that communicates with opening 56. The proximal end
59 of slot 58 meets a round opening 60 that is only slightly larger
than button 42 on tip 14. The diameter of round opening 60 slightly
exceeds the width of slot 58 at end 59.
[0060] FIGS. 6A-6E show an inventory of tips 14 compatible with
handle 12. Treatment ends 22 of tips 14 have a variety of
configurations. For example, some tips 14 have treatment ends with
a flat distal surface 24 (e.g., treatment end 22) which may be
beveled (e.g., treatment end 22.sub.3), while others tips 14 have a
concave distal surface 24 (e.g., end 22.sub.4). Still other tips 14
in the inventory have treatment ends that are tapered to a fine
point (e.g., treatment end 22.sub.10), to a round, blunt distal
surface 24 (e.g., treatment end 22.sub.6) or to a flat surface
(e.g., end 22.sub.5). The treatment ends of some tips form a
straight line from housing 28 to surface 24 (e.g., end 22), while
others include a bend of 30.degree., 45.degree., or 90.degree.
(e.g., ends 22.sub.7, 22.sub.6, 22.sub.9, respectively). Another
type of tip 14 includes a treatment end 22.sub.13 with two bends,
appropriate for performing a capsulotomy.
[0061] In operation, a user selects a tip 14 from the inventory and
inserts the selected tip 14 into handle 12 simply by aligning
protrusion 38 on housing 28 with slot 58 in handle 12 and inserting
connection end 25 of tip 14 into handle opening 56. The proximal
end of housing 12 enters handle opening 56, and protrusion 38
slides into slot 58. As button 42 of protrusion 38 enters round
opening 60, end 59 of slot 58 expands. After tip 14 is fully
inserted, end 59 of slot 58 snaps back to its original size to hold
button 42 firmly in opening 60. The exterior surfaces of housing
sections 32, 34 also frictionally engage inner surfaces 70, 72 of
opening 56. Tip 14 is thus held in handle 12 by a friction fit as
well as by a snap fit.
[0062] As tip 14 is being inserted, outer electrode 18 and
insulator 20 enter contact 76, and outer electrode 18 firmly
contacts conductor 75. Similarly, inner electrode 16 slides into
contact 74 and receptacle 78, and proximal end 17 of electrode 16
engages conductor 77. Friction between the adjacent surfaces of
electrodes 16, 18 and conductors 77, 75 provides a reliable, secure
electrical connection, and also helps avoid tip 14 disengaging from
handle 12.
[0063] Referring to FIG. 7, the user connects device 10 to a high
frequency power source 150 by connecting a standard socket 152 on a
cable 153 to connector pins 88, 90. Power source 150 provides
electrical power to contacts 74, 76 via pins 88, 90, which in turn
provide the power to electrodes 16, 18 (FIG. 1). Holding body 50 of
handle 12 and housing 28 of tip 14, the user places surface 24 of
electrodes 16, 18 on tissue 154 to be treated, e.g., within the
eye. The voltage applied by electrodes 16, 18 induces a high
frequency current in the tissue, thereby performing cauterization,
coagulation, or other surgical operations.
[0064] After use, the user detaches tip 14 from handle 12 by
pulling tip 14 axially out of opening 56. Protrusion 38 on tip 14
forces edges 59 of slot 58 outward as button 42 is pulled through
slot 58. The user discards tip 14, and sterilizes handle 12 (e.g.,
by autoclaving) for subsequent use.
[0065] The user then selects a new tip from the inventory of tips.
For example, the user may choose tip 14 with treatment end
22.sub.1, shown in FIG. 7. The user then inserts the new tip in
handle 12, as described above, and performs a new surgical
procedure.
[0066] Alternatively, the user may sterilize and reuse tip 14
instead of discarding tip 14 after a single use. In this case, tip
14 would be made from reusable material capable of, e.g.,
withstanding autoclaving.
[0067] Proximal section 55 and distal section 54 of handle 12 may
also be combined into a unitary, molded body. The handle and tip
may have other shapes: For example, referring to FIG. 8, surgical
device 100 has a non-cylindrical handle 112 that axially tapers
between relatively large diameter regions 112a, 112c and smaller
waist regions 112b, 112d. This contoured shape fits comfortably in
the user's hand. In particular, narrow waist region 112d can be
gripped between the user's fingers to assist in precisely treatment
end 122 of tip 114 in the body.
[0068] The housing 128 of tip 114 is hourglass-shaped, tapering
from a relatively wide proximal region 129 to a narrow intermediate
waist 130, and then to a somewhat larger-diameter distal region
131. With this shape, housing 128 fits securely in the user's hand
(with waist 130 being gripped between the user's fingers) when
inserting tip 114 into and removing tip 114 from handle 112. Both
handle 112 arid tip housing 128 may be ribbed 133 to further
enhance gripping.
[0069] Referring to FIGS. 9-27, tip 14 (or tip 114) may be
delivered in a reinforced, sterile "blister" package 200 which
allows for easy insertion of the tip onto handle 12 arid removal of
the tip from the handle, without any direct contact between the
user's hand and the tip. Package 200 can be sterilized and sealed
within a sterile pouch (not shown) for use during surgery. Package
200 containing tip 14 may also be sterilized after insertion in the
sterile pouch preferably using ethylene oxide (ETO) or gamma
rays.
[0070] Package 200 is made from a single piece of thin, flexible
plastic material, preferably 0.015 inch thick Kodak "Kodar" 6763
clear co-polyester medical PETG. Another material that may be used
for package 200 is polyvinyl chloride. Package 200 is preferably
made by vacuum molding the plastic material. Other methods of
making package 200 include injection molding and pressure or vacuum
thermoforming of the plastic material.
[0071] Referring to FIGS. 9-11, package 200 includes a top portion
205 and a bottom portion 206 connected by a rigid hinging segment
207. Hinging segment 207 includes two hinging points 207a which
create a blunt shelf 207b, and two walls 207c which provide
rigidity for the hinging segment. Package 200 is folded into a
closed position by folding top portion 205 and bottom portion 206
toward each other along hinging segment 207, and forming the
hinging segment itself by folding along hinging points 207a. FIGS.
9 and 10 show package 200 prior to folding, and FIGS. 11-14 show
the package with the top and bottom portions folded together.
[0072] Referring to FIGS. 11-14, when package 200 is folded
together, molded top portion 205 and molded bottom portion 206 form
a cavity 220 shaped to receive the entire tip 14. Top portion 205
and bottom portion 206 both include flat surfaces 262 and 264 that
substantially meet each other when package 200 is folded together.
Cavity 220 may be shaped to accept, discharge and protect all types
of shapes of tips that are used with handle 12 (e.g., the tips
shown in FIGS. 6A-6E). Cavity 220 includes an upper chamber 224 and
a lower chamber 226. Cavity 220 is also shaped to receive the
conically shaped housing 28 of tip 14, including sloping, grooved
exterior surface 30. Cavity 220 has an opening 222 into lower
chamber 226 that is large enough only to receive the end of handle
12 for inserting tip 14 onto and removing the tip from the handle.
The electrical contacts of the tip electrodes which extend from tip
14 and attach to handle 12 are recessed within opening 222 to avoid
accidental contact with the user's hands.
[0073] Upper chamber 224 is formed by molded sections 208 and 209
in top portion 205 and bottom portion 206, respectively, when the
top and bottom portions are folded toward each other. Upper chamber
224 is large enough to accommodate the electrodes of both straight
and bent tips, such as the tips shown in FIGS. 6A-6E.
[0074] Housing 28 of tip 14 is securely held and properly oriented
in package 200 within lower chamber 226. Lower chamber 226 includes
positioning cavity 201 and a releasable locking mechanism, which
includes locking recesses 202, 202a and ramps 203, 203a adjacent to
the locking recesses. Positioning cavity 201 is shaped to receive
tab 40 and button 42 of protrusion 30 on tip 14. Positioning cavity
201 prevents tip 14 from rotating about central axis 260 within
cavity 220. Positioning cavity 201 also prevents damage to the
electrodes of tip 14 by restraining the tip from being pushed too
far forward into upper chamber 224.
[0075] Tip 14 is rearwardly retained within cavity 220 by locking
recesses 202, 202a. Locking recesses 202, 202a protrude into the
path of movement of tip 14 along central axis 260 to hold the tip
in place and prevent the tip from sliding out of opening 222.
Locking recesses 202, 202a can be separated slightly radially
outward from central axis 260 by pushing against ramps 203, 203a to
release tip 14 from cavity 220.
[0076] Top portion 205 includes molded pockets 210, and bottom
portion 206 includes corresponding molded interlocking bosses 211.
Pockets 210 and bosses 211 are positioned so that when top portion
205 and bottom portion 206 are folded toward each other, the bosses
engage the pockets. Bosses 211 are shaped so that they fit snugly
into and are frictionally held within corresponding pockets 210
when the bosses are firmly pushed into the pockets. The combination
of pockets 210 and bosses 211, as well as rigid hinging segment
207, helps to maintain package 200 in a closed position during
shipping and usage, but allows the package to be opened manually if
necessary.
[0077] Top portion 205 and bottom portion 206 also contain
interlocking horseshoe-shaped ribs 248 and 250, respectively, which
provide additional rigidity to package 200. Ribs 248 and 250 also
provide a 4-layer barrier between cavity 220 and the package
exterior to help to avoid accidental release of the tip retained in
the package and to prevent the sharp end of the tip electrode from
sliding out through the sides of package 200. As with pockets 210
and bosses 211, ribs 248 and 250 are positioned so that when top
portion 205 and bottom portion 206 are folded together the ribs
engage each other, and the ribs are shaped so that one of the ribs
fits snugly into and is frictionally held within corresponding the
rib. Hinging segment 207 and ribs 248 and 250 prevent accidental
opening of package 200 during insertion of tip 14 onto and removal
of the tip from handle 12, which helps to avoid contact between the
tip and the user's hand.
[0078] Double arrows 242 molded into top portion 205 indicate the
location for proper placement of the user's fingers to grasp
package 200 during insertion of tip 14 onto and removal of the tip
from handle 12. Single directional arrow 244 molded onto the top
portion 205 of package 200 indicates the direction of handle
movement and ensures correct alignment between handle 12 and tip 14
during insertion and removal. Top portion 205 may also contain a
labeling area 246, in which a message or text is molded into the
plastic, preferably by hot stamping.
[0079] Referring to FIGS. 11-13, package 200 is used to insert tip
14 onto and to remove the tip from handle 12 without direct contact
between the tip and the user's hand. To insert tip 14 onto handle
12, the user firmly grasps package 200 between double arrows 242
and pushes the end of the handle into opening 222 along the
direction of single directional arrow 244. When the end of handle
12 is pushed into package 200 through opening 222, bevel 57 of
handle 12 urges locking recesses 202, 202a radially outward and
away from tip housing 28 by pushing against ramps 203, 203a, thus
releasing tip 14 from lower chamber 226. Handle 12 is pushed into
cavity 220 until tip 14 is fully inserted onto the handle. The
interface between tip 14 and handle 12 prevents locking recesses
202, 202a from recapturing tip housing 28 during withdrawal of the
handle from package 200 with the fully inserted tip.
[0080] To remove inserted tip 14 from package 200, the user
releases the tension placed on the package between double arrows
242 and withdraws handle 12 in the direction opposite to single
directional arrow 244. The retention of tip 14 on handle 12 is
sufficient to keep tip 14 fully inserted on handle 12 during
withdrawal from package 200 and during use in a surgical procedure,
but allows for ease of removal of tip 14 from handle 12 with or
without the use of package 200.
[0081] Package 200 may also be used to remove an inserted tip 14
from handle 12. The user pushes handle 12 with inserted tip 14 into
opening 222 in the direction of arrow 244, making sure that
protrusion 30 of tip 14 is aligned to slide into positioning cavity
201. As the user pushes handle 12 through opening 222 and tip 14
enters cavity 220, bevel 57 of handle 12 contacts ramps 203, 203a
to urge locking recesses 202, 202a radially outward from central
axis 260, allowing tip 14 to fully enter cavity 220. The user then
grasps package 200 between double arrows 242 with his or her
fingers to apply pressure to hold tip 14 within cavity 220. Tip 14
is then separated from handle 12-by pulling the handle away from
the tip. As the user withdraws handle 12 from opening 222, the
interface between tip 14 and handle 12 separates, and handle 12
moves down ramps 203, 203a allowing locking recesses 202, 202a to
recede radially inward toward central axis 260 and recapture tip
14. Tip 14, securely held within its package 200, may then be
discarded or stored for subsequent use during the same surgical
procedure.
[0082] The use of package 200 for each tip provides the user with
efficient access to a variety of different tips during surgery.
Since a tip may be used several times for the same patient during a
single surgical procedure, the tips used with the patient may be
efficiently stored in their packages during the surgical procedure,
without contamination due to handling by the user. The return of
the tips to their packages during a surgical procedure allows for
minimal disposal and waste of tips. Further, by placing each tip
into its package after it is used during a surgical procedure, a
variety of tips used with a single handle during the surgical
procedure may be efficiently organized.
[0083] Moreover, package 200 allows the user to remove used tips
from the handle in a simple fashion and without direct contact
between the tips and the user's hand. Thus, patient-contaminated
tips may be safely manipulated and stored during surgery and
disposed of after surgery. In particular, use of the package to
insert tips onto and remove tips from the handle decreases the risk
of puncturing hazardous waste bags and infecting the user or
clinical staff.
[0084] Other embodiments are within the following claims. For
example, the package can also be used with monopolar, diathermized
and non-bipolar tips, as well as other sharp tips such as cannulae,
pics and blades, that are removably attachable to a handle.
[0085] What is claimed is:
* * * * *