U.S. patent application number 11/318410 was filed with the patent office on 2006-05-11 for surgical stapling device.
This patent application is currently assigned to Temedco, Ltd.. Invention is credited to Phillip Clay Brown.
Application Number | 20060097027 11/318410 |
Document ID | / |
Family ID | 29586321 |
Filed Date | 2006-05-11 |
United States Patent
Application |
20060097027 |
Kind Code |
A1 |
Brown; Phillip Clay |
May 11, 2006 |
Surgical stapling device
Abstract
A surgical stapling device having a removable staple cartridge
is disclosed. The cartridge includes a first opening in the
staple-forming end of the housing member to allow access to the a
staple and an aligned second opening to allow the lead staple to
move therethrough. The staple cartridge also comprises a fixed
blocking surface on the housing member and a traveling blocking
surface on a feeder shoe. The traveling blocking surface is sized
so that the feeder shoe moves relative to the fixed blocking
surface while moving the staple. The feeder shoe is further shaped
so that, when the trigger member is actuated when no staples remain
in the staple cartridge, the staple former is not blocked by the
feeder shoe.
Inventors: |
Brown; Phillip Clay; (El
Paso, TX) |
Correspondence
Address: |
AKIN, GUMP, STRAUSS, HAUER & FELD
1111 LOUISIANA STREET
44TH FLOOR
HOUSTON
TX
77002
US
|
Assignee: |
Temedco, Ltd.
San Antonio
TX
|
Family ID: |
29586321 |
Appl. No.: |
11/318410 |
Filed: |
December 23, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10227947 |
Aug 26, 2002 |
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11318410 |
Dec 23, 2005 |
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10156716 |
May 28, 2002 |
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10227947 |
Aug 26, 2002 |
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Current U.S.
Class: |
227/175.1 |
Current CPC
Class: |
A61B 17/0684 20130101;
A61B 2017/0688 20130101 |
Class at
Publication: |
227/175.1 |
International
Class: |
A61B 17/10 20060101
A61B017/10 |
Claims
1. A surgical stapling device, comprising: a body member having a
staple cartridge recess; a staple former movably positioned with
the body member; an anvil member positioned with the body member;
and means for moving the staple former between an at-rest position
and a staple-forming position.
2. The surgical stapling device of claim 1, further comprising a
staple cartridge removably positioned with the staple cartridge
recess, wherein when the staple cartridge is removed from the
staple cartridge recess, the anvil member remains positioned with
the body member.
3. The surgical stapling device of claim 1, further comprising a
staple cartridge removably positioned with the staple cartridge
recess, wherein when the staple cartridge is removed from the
staple cartridge recess, the staple former remains positioned with
the body member.
4. The surgical stapling device of claim 1, wherein the anvil
member having an anvil end.
5. The surgical stapling device of claim 1, wherein the means for
moving includes a trigger member.
6. A surgical stapling device, comprising: a body member having a
staple cartridge recess; a staple former movably positioned with
the body member; a staple cartridge having a staple, the staple
cartridge removably positioned with the staple cartridge recess;
and an anvil member positioned with the body member for
transforming the staple from a pre-implantation configuration to a
post-implantation configuration upon moving the staple former from
an at-rest position to a staple-forming position.
7. The surgical stapling device of claim 6, wherein the staple
cartridge comprises: a housing member having a staple-forming end;
and an opening adjacent the staple-forming end of the housing
member to allow a portion of the staple former to move
therethrough.
8. The surgical stapling device of claim 7, further comprising a
feeder shoe in the housing member, wherein when the feeder shoe
engages the staple-forming end of the staple cartridge, the staple
former will urge the feeder shoe away from the staple-forming
end.
9. A surgical stapling device, comprising: a body member having a
staple cartridge recess; a staple former movably positioned with
the body member; and a staple cartridge, comprising: a housing
member having a staple-forming end; a staple movably positioned in
the housing member; a feeder shoe movably positioned in the housing
member for urging the staple towards the staple-forming end.
10. The surgical stapling device of claim 9, wherein the feeder
shoe moves between an engaged position with the staple-forming end
of the housing member and a position away from the staple-forming
end of the housing member when pressure is exerted by the staple
former upon the feeder shoe.
11. A surgical stapling device, comprising: a body member having a
staple cartridge recess; a staple former movably positioned with
the body member; and a staple cartridge, comprising: a housing
member; and means for removably positioning the staple cartridge
with the staple cartridge recess.
12. The surgical stapling device of claim 11, wherein the means for
removably positioning the staple cartridge including a flexible arm
extending from the housing member and moving between a memory
position and a flexed position whereby a greater clearance is
provided between the flexible arm and the housing member when the
flexible arm is in the flexed position.
13. The surgical stapling device of claim 12, wherein the housing
member having a staple-forming end and the flexible arm is proximal
to the staple-forming end of the housing member.
14. A surgical stapling device, comprising: a body member adapted
to receive a staple cartridge; a staple former movably positioned
with the body member; and a staple cartridge, comprising: a housing
member having a snap fit for removably positioning the staple
cartridge with the body member.
15. The surgical stapling device of claim 14, wherein the housing
member is biased towards a memory position to engage the body
member.
16. A surgical stapling device, comprising: a body member having a
staple cartridge recess; a staple former movably positioned with
the body member; and a staple cartridge, comprising: a housing
member having a staple-forming end; a feeder shoe movably
positioned in the housing member and having a surface angled
relative to the staple-forming end of the housing member; a staple
urged by the feeder shoe towards the staple-forming end; and an
opening adjacent the staple-forming end sized to allow the staple
to move through the opening.
17. The surgical stapling device of claim 16, wherein the feeder
shoe moves between an engaged position with the staple-forming end
of the housing member and a position away from the staple-forming
end of the housing member when pressure is exerted upon the angled
surface by the staple former.
18. A surgical stapling device, comprising: a body member having a
staple cartridge recess; a staple former movably positioned with
the body member; and a staple cartridge, comprising: a housing
member having a staple-forming end; a staple movably positioned in
the housing member; and a feeder shoe movably positioned in the
housing member for urging the staple towards the staple-forming
end; and an anvil member positioned with the body member for
transforming the staple from a pre-implantation configuration to a
post-implantation configuration upon moving the staple former from
an at-rest position to a staple-forming position.
19. The surgical stapling device of claim 18, wherein the housing
member having a first opening adjacent the staple-forming end of
the housing member to allow a portion of the staple former to move
therethrough.
20. The surgical stapling device of claim 19, wherein the housing
member having a second opening adjacent the staple-forming end of
the housing member to allow the staple to move through the second
opening.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of co-pending U.S.
application Ser. No. 10/227,947, entitled "Surgical Stapling
Device," filed Aug. 26, 2002, which is a continuation-in-part of
U.S. application Ser. No. 10/156,716 filed on May 28, 2002, now
abandoned, which are hereby incorporated by reference in their
entirety for all purposes.
STATEMENTS REGARDING FEDERALLY SPONSORED RESEARCH OR
DEVELOPMENT
[0002] Not applicable.
REFERENCE TO A MICROFICHE APPENDIX
[0003] Not applicable.
BACKGROUND OF THE INVENTION
[0004] 1. Field of the Invention
[0005] The present invention relates to health care devices
comprising medical and veterinary devices, and more particularly to
devices useful in suturing or closing wounds or incisions.
[0006] 2. Description of the Related Art
[0007] The use of surgical staples in the health care field,
comprising both the medical and veterinary fields, to close wounds
and incisions has begun to, in many contexts, replace conventional
suture ligature.
[0008] Surgical skin stapling has been found to be desirable in
that it requires less skill of the health care clinician than
conventional suture ligature. In addition, removal of staples is
faster and easier than suture ligature. As in most fields,
simplicity in wound and incision closure decreases the possibility
of error, an accomplishment of particular importance in the health
care field. Surgical stapling also provides better post-surgery
aesthetic appearance than does conventional suture ligature and
needle wound closure. Further still, postoperative infection is
reduced in the use of skin stapling over suture ligature.
[0009] Because surgical stapling takes less time than conventional
suture ligature, surgical stapling is economically advantageous.
Both implanting and removing surgical staples is easier than
placing and removing conventional sutures. It is, for example,
estimated that the typical surgical stapling operation takes
approximately 10% of the time of a conventional ligature placement.
Thus, a significant time savings is involved in using surgical
staples for wound and incision closure.
[0010] However, not all clinicians are able to take advantage of
stapling technology because available surgical stapling devices are
expensive. For example, clinicians who work in low-income regions
or without insurance support, are often unable to afford currently
available surgical staple devices and supplies. However, clinicians
and their patients who can afford stapling devices end up
benefiting economically in the long run.
[0011] While advantageous in the respects discussed, current
surgical stapling devices present certain limitations. First,
surgical stapling devices without a removable cartridge are
designed so that the entire stapling device is discarded after all
staples have been used. Such stapling devices are not economically
advantageous in the long run. Also, because all parts of such a
stapling device are disposed of after the staples are used, the
quality of the parts must be sacrificed to keep costs down.
However, if premium quality components are used, disposing of these
parts each time the staples are used raises the cost of using the
stapling device.
[0012] Current surgical stapling devices which do use a replaceable
staple cartridge minimize the waste of many functional components
of the stapling device. This recycling of parts for reuse is
economically advantageous. However, current surgical stapling
devices employing a replaceable cartridge do not allow for reuse of
both a staple former and an anvil. Some of the staple cartridges
currently in use include both a staple former and an anvil as an
integral part of the replaceable cartridge, and all cartridges
include at least an anvil or a staple former. By including an anvil
and/or a staple former as an integral part of a replaceable
cartridge, these components are disposed of with the staple
cartridge. Reducing the disposal of functional parts is
economically advantageous. Therefore, it is desirable to have a
surgical stapling device in which a stapling cartridge does not
include either a staple former or an anvil as an integral component
of the staple cartridge.
[0013] Current surgical staple devices generally provide a feeder
shoe to urge a plurality of staples toward the staple-forming or
exiting end of the stapling device. A limitation in such feeder
shoes and urging mechanisms is that staples are allowed to jam on
the sliding surface as the staples move toward the staple-forming
or exiting end of the stapling device.
[0014] Such staple jams can be at least inconvenient to clinicians
who temporarily cannot utilize the stapling device. A limitation in
the feeder shoes and urging mechanisms which can lead to staple
jams is that while all such feeder shoes contact at least a part of
one of the staples, and some feeder shoes contact much of one side
of a staple, when a staple slips, the staple can be lodged in
spaces either between the staple stack containing a plurality of
staples and the track upon which the plurality of staples slide,
within other spaces existing within the feeder shoe itself, or
between the feeder shoe and the track upon which the staple stack
slides. It is therefore desirable to have a staple housing, such as
a staple cartridge, in which the outer surfaces of a feeder shoe
are continuous with the staple housing and in which the feeder shoe
acts as a traveling blocking surface against a fixed blocking
surface.
[0015] Another limitation of current feeder shoes is that if such
feeder shoes are extended completely to the end of the staple
cartridge, as when all staples in the staple cartridge have been
used so that no staples remain in the staple cartridge, forcing the
staple former on the feeder shoe can damage these parts. It is
therefore desirable to avoid this force on the feeder shoe and
staple former.
[0016] Finally, a limitation of current surgical stapling devices
is that staples are implanted substantially orthogonal to the skin
surface. By inserting staples at an angle of between about
10.degree.-45.degree. relative to the skin surface and then tilting
the staple so that the staple is ultimately positioned
substantially orthogonal to the skin surface, greater resulting
anastomosis can be obtained as the skin grows together. This
greater anastomosis allows for shorter healing time. Thus, it is
desirable to have a stapling device in which a staple can be
inserted at an angle of about 10.degree.-45.degree. relative to the
skin, the staple subsequently rotated to a final orientation being
substantially orthogonal to the skin's surface.
BRIEF SUMMARY OF THE INVENTION
[0017] According to the invention, a surgical stapling device has a
body member having a staple cartridge recess, a trigger member
movably positioned with the body member, a staple former positioned
with the body member movably positioned with the trigger member, a
staple cartridge having a staple, the staple cartridge removably
positioned with the staple cartridge recess and an anvil member
positioned with the body member for transforming the staple from a
pre-implantation configuration to a post-implantation configuration
upon movement of the trigger member from an at-rest position to a
staple-forming position. The preferred embodiment also includes a
body member having an aligning surface for implantation of the
staple at an insertion angle relative to the skin surface of
between about 10.degree. and about 45.degree..
[0018] The surgical staple cartridge includes a housing member
having a staple-forming end, a plurality of staples having a lead
staple movably positioned in the housing member and a first opening
in the staple-forming end of the housing member to allow access to
the lead staple and a second opening in the staple-forming end of
the housing member to allow the lead staple to move therethrough.
The staple cartridge preferably contains a feeder shoe for urging
the plurality of staples toward the staple-forming end of the
housing member. To prevent staple jamming, the staple cartridge
also preferably contains a fixed blocking surface on the housing
member and a traveling blocking surface on the feeder shoe. The
traveling blocking surface is sized so that the feeder shoe moves
along the fixed blocking surface of the housing member while
blocking the staple. The staple cartridge also preferably includes
a flexible arm extending from the housing member and moving between
a memory position and a flexed position outwardly from the memory
position for a snap fit of the staple cartridge to the stapling
device. Additionally, the feeder shoe is angled to prevent damage
to the staple former and feeder shoe when the trigger member is
squeezed when no staples remain in the staple cartridge.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0019] Various objects and advantages of this invention will become
apparent and more readily appreciated from the following
description of the presently preferred exemplary embodiments, taken
in conjunction with the accompanying drawings, of which:
[0020] FIG. 1 is a side elevational view of the right body member
half of the surgical stapling device of the present invention to
better illustrate the trigger member in the at-rest position.
[0021] FIG. 2 is a side elevational view of the right body member
half of the stapling device of the present invention to better
illustrate the trigger member in the staple-forming position.
[0022] FIG. 3 is a cross sectional view taken along section line
3-3 of FIG. 1.
[0023] FIG. 4 is a cross sectional view taken along section line
4-4 of FIG. 2.
[0024] FIG. 5 is an exploded view of right and left body member
halves to better illustrate the trigger member, anvil, staple
cartridge and staple former.
[0025] FIG. 6 is a fragmentary side elevational view of the right
body member half of the stapling device of the present invention to
better illustrate the insertion of the staple cartridge into the
staple cartridge recess.
[0026] FIG. 7 is a fragmentary side elevational view of the right
body member half of the stapling device of the present invention to
better illustrate the inserted staple cartridge relative to the
staple former.
[0027] FIG. 8 is an enlarged fragmentary cross sectional view,
taken along section line 8-8 of FIG. 7.
[0028] FIG. 9 is a fragmentary cross sectional view, taken along
section line 9-9 of FIG. 8.
[0029] FIG. 10 is a fragmentary cross sectional view similar to
FIG. 9, illustrating insertion by the surgical stapling device of
the present invention of a pre-implantation configured staple into
skin.
[0030] FIG. 11 is a fragmentary cross sectional view similar to
FIGS. 9 and 10, illustrating insertion of a post-implantation
configured staple in the skin.
[0031] FIG. 12 is a fragmentary cross sectional view similar to
FIGS. 9-11, illustrating a post-implantation configured staple in
the skin.
[0032] FIG. 13 is an enlarged cross sectional view taken along
section line 13-13 of FIG. 11.
[0033] FIG. 14 is an enlarged cross sectional view taken along
section line 14-14 of FIG. 11.
[0034] FIG. 15 is a perspective exploded view of the staple
cartridge of the present invention.
[0035] FIG. 16 is a perspective view of the feeder shoe of the
present invention.
[0036] FIG. 17 is a fragmentary top elevational view of the staple
cartridge of the present invention inserted into the stapling
device.
[0037] FIG. 18 is a fragmentary cross sectional view of the staple
cartridge of the present invention inserted into the stapling
device and with the staple former in the at-rest position.
[0038] FIG. 19 is a fragmentary cross sectional view of the staple
cartridge of the present invention with the staple former urging
the feeder shoe away from the staple-forming end of the staple
cartridge.
[0039] FIG. 20. is a fragmentary top elevational view of the anvil
of the housing member of the present invention.
[0040] FIG. 21 is a fragmentary side elevational view of the
stapling device of the present invention to better illustrate the
relationship of the implanted staple and the anvil.
[0041] FIG. 22 is a fragmentary side elevational view of the
stapling device of the present invention to better illustrate the
relationship of the implanted staple and the anvil.
DETAILED DESCRIPTION OF THE INVENTION
[0042] As shown in FIG. 1, the surgical stapling device of the
present invention comprises a body member, generally indicated as
10, and a trigger member 12 movably positioned with the body member
10. As best shown in FIG. 5, the trigger member 12 is pivotally
movable about a trigger pivot opening 12C. Preferably, the body
member 10 comprises a right body member half 10A and a left body
member half 10B. The body halves are assembled in mated
relationship, as best shown in FIG. 5. Also as shown in FIG. 5, the
trigger pivot opening 12C is received about right trigger pivot
male member 14A and a left trigger pivot female member 14B that are
interengaged in a mated relationship. As best shown in FIG. 4, the
body member 10 has a rearward portion 10C constituting a handle
portion and a forward portion 10D. As best shown in FIGS. 6 and 7,
a staple cartridge 16 is located within a staple cartridge recess
18 in the forward portion 10D. Returning to FIG. 1, the rearward or
handle portion 10C of body member 10 is used at an angle related to
the forward portion 10D so that the instrument can be properly
positioned in the hand of a clinician. An aligning surface 10E of
the body member 10 facilitates application of staples at a
consistent angle relative to the skin surface. As shown in FIGS. 1
and 2, this insertion angle is about 10.degree.. However, other
embodiments consistent with the present disclosure provide for
aligning surfaces corresponding to insertion angles of about
10.degree. to about 45.degree. relative to the skin surface. The
desired angle will be determined by the height of the user of the
stapling device. For example, a shorter person would desire a
smaller angle.
[0043] Turning again to FIG. 5, the right body member half 10A has
edge portions 10F, 10G and 10H adapted to engage and be joined to
edge portions 101, 10J and 10K, respectively, of left body member
half 10B. As can be seen from FIG. 3, right and left body member
halves 10A and 10B are oppositely stepped so as to have an
overlapping mating relationship when abutted. As shown in FIG. 5,
right body member half 10A has five male members 20A, 22A, 24A, 26A
and 28A formed thereon. The left body member half 10B has five
corresponding female members 20B, 22B, 24B, 26B and 28B thereon.
When the body member halves 10A and 10B are joined together, male
members 20A, 22A, 24A, 26A and 28A are received within female
members 20B, 22B, 24B, 26B and 28B, respectively, with a snap fit.
The pivot members 14A and 14B are simultaneously snap fitted when
the halves are joined.
[0044] The body member halves 10A and 10B in the embodiment
illustrated are molded of appropriate plastic material suitable for
use in a surgical environment and capable of withstanding
sterilization by any one or more of the standard sterilization
procedures well known in the art. Preferably, a polycarbonate or
like thermoplastic resin is used. Once the internal components of
the surgical stapling device (to be described hereinafter) have
been assembled in one of the body halves, the body halves are
joined together. The halves are joined preferably by an arbor
press, but may be joined by any similar joining means known in the
art. In addition to the frictional engagement of female members
20B, 22B, 24B, 26B and 28B with male members 20A, 22A, 24A, 26A and
28A, the mated edges 10F, 10G and 10H and 10I, 10J and 10K may be
permanently bonded by gluing, welding or the like. It will be
understood by one skilled in the art that if the instrument of the
present invention is to be non-disposable and reusable, body member
halves 10A and 10B can be fabricated of stainless steel or other
appropriate material suitable for use in a surgical environment and
capable of being sterilized. Under such circumstances, the body
member halves 10A and 10B will be held together by removable
fastening means such as screws or the like.
[0045] Remaining at FIG. 5, right body member half 10A has an
annular flange 30A, a rectilinear flange 32A, and three
triangularly conjoined rectilinear flanges 34A, 36A and 38A. The
left body member half 10B has an annular flange 30B, equivalent to
annular flange 30A, a rectilinear flange 32B, equivalent to
rectilinear flange 32A, and three triangularly conjoined
rectilinear flanges 34B, 36B and 38B equivalent to flanges 34A, 36A
and 38A, respectively. When the body halves are assembled, annular
flanges 30A and 30B are opposed and coaxial, and flanges 32A, 34A,
36A and 38A are in opposed relationship to flanges 32B, 34B, 36B
and 38B, respectively.
[0046] Reference is now made to FIGS. 1 and 2, which illustrate the
right body member half 10A of the stapling device with the internal
elements mounted therein. Turning first to the forward portion 10D
of the stapling device, there is housed therein an anvil member 40.
The anvil member 40 is best seen in FIG. 20. The anvil member 40 is
preferably formed of an appropriate metal for use in a surgical
environment, such as stainless steel or the like. The anvil member
40 has a longitudinally extending raised central portion 42. At its
forwardmost end, the raised central portion 42 has an extended tab
40A comprising an integral one-piece part of the raised central
portion 42 and lying at a slight angle thereto. The tab 40A
constitutes an anvil and the upper surface 40B of tab 40A
constitutes an anvil surface which is coextensive with the upper
surface of the raised central portion 42.
[0047] Remaining at FIG. 20, the raised central portion 42 of anvil
member 40 has lateral edges which terminate in downwardly depending
portions 40C and 40D (see also FIG. 3). The downwardly depending
portions 40C and 40D, in turn, terminate in laterally extending
flanges 40E and 40F. Flange 40E is provided with three extensions
40, 40H and 401. Similarly, flange 40F is provided with three
extensions 40J, 40K and 40L. The right body member half 10A (see
FIG. 20) has three recesses 10L, 10M and 10N formed therein. In
similar fashion, the left body member half 10B has three recesses
10P, 10Q and 10R formed therein. When the body member halves 10A
and 10B are joined together with the anvil member 40 properly
located therebetween, the extensions 40G, 40H and 40I of flange 40E
will be received within recesses 10L, 10M and 10N of right body
member half 10A, respectively. Similarly, the extensions 40J, 40K
and 40L of flange 40F will be received within recesses 10P, 10Q and
10R of left body member half 10B. In this way the anvil member 40
is properly located and locked within the body halves. It is also
evident from FIG. 3 that anvil member flanges 40E and 40F rest upon
the bottom portions of right and left body halves 10A and 10B.
[0048] Turning now to FIGS. 6, 7 and 9, mounted within the forward
portion 10D of the stapling device body member 10 there is a staple
former 44. As can be best seen in FIG. 9, the staple former 44
comprises a substantially planar, substantially rectangular element
preferably made of metal suitable for use in a surgical
environment, such as stainless steel or the like. The staple former
44 is provided with a tab 44A rearwardly extending from the staple
former 44. The purpose of the tab 44A will be described
hereinafter.
[0049] At its lowermost end the staple former 44 has staple-forming
notches 44B and 44I formed therein, as shown in FIG. 9. To the
right side of staple-forming notch 44B and the left side of
staple-forming notch 441 are two prongs 44C and 44D of staple
former 44. At the lowermost corners 44E and 44F of the notches, the
staple former 44 may be slightly rounded, as shown in FIG. 9. This
assists in bending the staples, as will be described hereinafter.
The lowermost edges 44G and 44H and the adjacent rounded corners
44E and 44F (the first portions of the staple former 44 to contact
the crown of a staple) may be slightly grooved to assure that the
staple being formed by the staple former 44 is properly aligned
during the initial phase of the staple-forming procedure.
[0050] As is most clearly shown in FIG. 6, the staple former 44 is
located in abutment with the front inside surface 10S of the
forward portion 10D of the body member 10. The staple former 44 is
slidable along inside surface 10S between a first retracted or
at-rest position illustrated in FIGS. 1, 6, 7 and 9, and a second
extended or staple-forming position shown in FIGS. 2 and 11. Female
member 26B, which receives male member 26A as shown in FIG. 5,
serves as a stop for nose portion 12B of trigger member 12 so as to
determine a first retracted or at-rest position of staple former
44.
[0051] To shift the staple former 44 between its first and second
positions, as illustrated in FIGS. 1 and 2, the trigger member 12
is actuated. The trigger member 12 (best shown in FIG. 5) lends
itself well to be molded of an appropriate plastic material for use
in a surgical environment and comprises a handle portion 12A and a
nose portion 12B. The handle portion 12A is hollow and extends
through an elongated opening created by edges 10T (see FIGS. 1, 2,
and 5) in the body member 10. The lower edge portion of trigger
member 12 is adapted to be grasped by the fingers of the clinician
and, to this end, may be notched or serrated as at 46. The nose
portion 12B of trigger member 12 is on the other side of trigger
pivot opening 12C. The trigger pivot opening 12C is adapted to
rotatively receive annular flange 30A of right body member half 10A
and annular flange 30B of left body member half 10B.
[0052] As best shown in FIG. 5, the nose portion 12B of trigger
member 12 terminates in surfaces 12D and 12E, flanking a central
surface 12F. As best shown in FIGS. 6 and 7, the forward end of
nose portion 12B comprises an attachment channel 12G which is
adapted to receive rearwardly extending tab 44A of staple former
44. Thus, the nose portion 12B of trigger member 12 maintains the
staple former 44 in abutment with the front inside surface 10S of
the forward portion 10D of the body member 10.
[0053] As shown in FIGS. 6 and 7, the tab 44A is inserted into an
attachment channel 12G at the forwardmost tip of nose portion 12B
of the trigger member 12. As shown in FIGS. 1 and 2, when handle
portion 12A of the trigger member 12 is squeezed against the action
of a leaf spring member, generally indicated at 48, the nose
portion 12B of the trigger member 12 pivots in a counterclockwise
direction so that the attachment channel 12G and tab 44A contained
therein moves downward toward the staple cartridge 16.
[0054] As is best shown in FIGS. 1 and 2, leaf spring member 48 is
mounted in the body member 10. The leaf spring member 48 is
substantially V-shaped, having a first leg 48A bearing against the
upper inside surface of body member 10 and a second leg 48B lying
along the upper surface of trigger member 12. Both legs move about
female member 24B. Leaf spring member 48 will maintain trigger
member 12 in its at-rest position, as illustrated in FIG. 1. This,
in turn, assures that staple former 44 is in its first retracted or
at-rest position. Upon squeezing trigger member 12 to cause it to
pivot in a counterclockwise position (as viewed in FIGS. 1 and 2),
the nose portion 12B thereof will cause staple former 44 to shift
to its second extended or staple-forming position, as shown in FIG.
2.
[0055] As best shown in FIGS. 5-8, the staple cartridge 16 is
removably inserted into the staple cartridge recess 18. As seen in
FIGS. 8 and 15, the staple cartridge 16 comprises a housing member
50. The housing member 50 is preferably constructed from an
appropriate plastic material for use in a surgical environment, but
may be made from any material appropriate for housing staples,
including metals.
[0056] A cap 52 is attached to the rear end of the housing member
50. The cap 52 is affixed to the housing member 50 by snaps,
generally indicated at 54A and 56A. Snap 54A is removably affixed
to snap receptacle 54B on the housing member 50. Snap 56A is
removably affixed to snap receptacle 56B on the housing member 50.
Snaps 54A and 56A are located on flexible arms 52A and 52B,
respectively, of the cap 52. As best seen in FIG. 8, the arms 52A
and 52B are biased outward toward a memory position resting against
housing member 50. The snaps are preferably bonded by permanent
bonding means known in the art such as ultrasonic bonding, gluing,
welding or any bonding method which can permanently affix the cap
52 to the housing member 50. It is intended that cap 52 upon being
affixed is not removable or replaceable and that staple cartridge
16 is not reusable.
[0057] As shown in FIG. 8, the cap 52 also comprises a pusher rod
58 centrally attached to the cap 52 of housing member 50. Housing
member 50 also includes flexible arms 50A and 50B, by which the
housing member 50 is attached to the body member 10 of the stapling
device by snaps, generally indicated as 60 and 62, respectively.
Snap 60 is removably affixed to snap receptacle 60A on side 10U of
body member 10 of the stapling device. Snap 62 is removably affixed
to snap receptacle 62A on side 10V of body member 10 of the
stapling device.
[0058] Snaps 60 and 62 are located on arms 50A and 50B,
respectively, of the housing member 50. Arms 50A and 50B are biased
inward toward a memory position against sides 10U and 10V of body
member 10, as seen in FIG. 8, but both arms 50A and 50B may be
flexed outward to insert and remove snaps 60 and 62.
[0059] As shown best in FIG. 17, housing member 50 comprises first
openings 50C and 50D adjacent the front or staple-forming end 50L
of housing member 50. First openings 50C and 50D are aligned
vertically with lead staple 64, as shown in FIG. 7. First openings
50C and 50D allow staple former 44 to move into housing member 50
and to apply a force to lead staple 64. As shown in FIG. 17, angled
surfaces assist in guiding prongs 44C and 44D of staple former 44
to lead staple 64.
[0060] A second opening 50G in the staple-forming end 50L of
housing member 50 is also aligned vertically with lead staple 64,
as shown in FIGS. 6 and 7, as well as FIGS. 17-19. This second
opening 50G is created by the ending of the bottom wall 66, as
shown in FIG. 7. The second opening 50G allows lead staple 64 to
move through the second opening 50G and strike anvil tab 40A upon
the lead staple 64 being struck by staple former 44.
[0061] As best shown in FIGS. 7 and 8, the staples of the staple
stack 72 are vertically oriented in the staple cartridge 16
relative to the movement of the staples along a substantially
straight movement path through the staple cartridge 16. When a
staple reaches the front or staple-forming end 50L of the staple
cartridge 16, the staple is vertically aligned with the first
openings 50C and 50D (FIG. 17) and second opening 50G (FIG. 19), as
described above, thus those openings 50C, 50D, and 50G are also
vertically oriented to the staple cartridge 16. Side 74D of the
feeder shoe 74 (FIG. 15) is also parallel with the crown portion
100 (FIGS. 12 and 14) of the staples of the staple stack 72, as
best shown in FIG. 8.
[0062] As best shown in FIG. 8, staple cartridge housing member 50
comprises staple feeder ramps 68 and 70 within housing member 50.
The staple stack 72 containing a plurality of staples in a
pre-implantation configuration (as seen in FIGS. 8-10) rests upon
staple feeder ramps 68 and 70, and slides toward the fixed front or
staple-forming end 50L of the staple cartridge 16 formed between
frontal tabs 50J and 50K (FIG. 15), upon the staple feeder ramps 68
and 70 when urged by the feeder shoe 74. As best shown in FIGS. 15
and 16, feeder shoe 74 comprises feeder ramp grooves 76 and 78,
through which staple feeder ramps 68 and 70 (see FIG. 8),
respectively, insert, allowing feeder shoe 74 to slidably travel
along staple feeder ramps 68 and 70 toward the front of staple
cartridge 16.
[0063] As shown best in FIG. 15, feeder shoe 74 also comprises a
groove 80. This groove 80 fits onto track 50H of the housing member
50, allowing the feeder shoe 74 to slidably travel along the upper
surface of track 50H toward the front of staple cartridge 16 with
guiding blocks 82 and 84 of feeder shoe 74 sliding along guiding
block grooves 86 and 88 of housing member 50, respectively. The
anvil member 40 rests against the bottom side of track 50H
comprising groove 501, as shown in FIG. 15.
[0064] It will be apparent from FIGS. 15 and 16 that when feeder
shoe 74 is slidably inserted into housing member 50, the feeder
shoe 74 is fully configured with the housing member 50 such that
both right and left sides 74A and 74B, respectively, as well as top
and bottom sides 74C and 74D, respectively, are in continuity with
all inside surfaces of housing member 50, so that staple feeder
ramps 68 and 70, track 50H, frontal tabs 50J and 50K and the
remaining inside surface of housing member 50 constitute a fixed
blocking surface while feeder ramp grooves 76 and 78, guiding
blocks 82 and 84, as well as the remaining outer surface of feeder
shoe 74, including sides 74A, 74B, 74C and 74D constitute a
traveling blocking surface. By reducing space between the outer
surfaces of feeder shoe 74 and the inner surfaces of housing member
50, the possibility of staple jamming is decreased because the
space into which a staple may lodge is reduced. Feeder shoe 74
additionally comprises a feeder rod 92. A spring 90 is positioned
with feeder rod 92 that is received in pusher rod 58, as best shown
in FIGS. 7, 8 and 15.
[0065] When cap 52 is affixed to housing member 50 using snaps 54A
and 56A, as previously described, cap tabs 94 and 95 fit within cap
tab inserts 96 and 97, as seen in FIGS. 15, 18 and 19. When cap 52
is so affixed, spring 90 exerts a force against feeder shoe 74,
biasing the feeder shoe 74 toward the front or staple-forming end
50L of staple cartridge 16. As best seen in FIG. 8, the feeder shoe
74 moves toward the front or staple-forming end 50L of housing
member 50, thus moving the staple stack 72 containing a plurality
of staples toward the front or staple-forming end 50L as well.
[0066] Feeder shoe 74 additionally comprises angles 74E and 74F. As
best shown in FIG. 16, the angles 74E and 74F each comprise a
surface slanted away from vertical toward the pusher rod 58 at an
angle of about 45.degree.. The angles 74E and 74F move the feeder
shoe 74 rearward toward the pusher rod 58 (toward the staple
feeding or rear end) when the prongs 44C and 44D of the staple
former 44 (see FIG. 9) strike the angles 74E and 74F, such as when
there are no more staples in staple cartridge 16. Such movement
prevents damage to the edges of the prongs 44C and 44D (see FIG. 9)
of the staple former 44 when the trigger member 12 is squeezed when
no staples remain in the staple cartridge 16. FIG. 18 shows a
staple cartridge 16 with no staples therein, with feeder shoe 74
engaged with frontal tabs 50J and 50K of housing member 50. FIG. 15
best illustrates the frontal tabs 50J and 50K. FIG. 19 shows feeder
shoe 74 moving rearward towards pusher rod 58 in response to a
downward strike by staple former 44 when no staples remain in the
staple cartridge 16.
[0067] As described previously, staples are inserted into the skin
surface at an insertion angle of about 10.degree. from vertical, as
best shown in FIG. 21. In order to bring the implanted staple to
vertical, the upper surface 40B of anvil tab 40A is angled upward
relative to the rest of the tab 40A. This provides frictional force
sufficient to rotate the implanted staple towards vertical when the
stapling device is moved rearwardly in the normal course of
inserting multiple staples. When the staple is near vertical, the
force of compressed skin pressing against the legs of the staple
exceeds the frictional force exerted by the upper surface 40B of
tab 40A on the crown of the staple, and the anvil 40 slides out
from underneath the crown portion 100 of the staple. As the staple
is brought to an angle near vertical as shown in FIG. 22, a
crowning space 98, as shown in FIG. 11, is minimized. FIG. 11
represents an implanted staple before the staple has been brought
to near vertical, and FIG. 12 represents an implanted staple after
the staple has been brought to near vertical. As can be seen in
FIG. 12, the crowning space 98 is smaller after the staple is
rotated. Minimizing the crowning space minimizes the possibility
that the crown portion 100 of the staple could be caught on an
object which would create trauma to the wound site so that healing
time is potentially decreased.
[0068] By inserting staples at an insertion angle of about
10.degree. and subsequently bringing the staple to near vertical as
described, the skin within the grasp of the staple is brought
closer together so that the skin is denser than otherwise. This is
shown in FIG. 22 by an increased number of striations 102 in the
skin. By increasing the skin density in this way, greater
anastomosis, or bringing together, of various skin elements is
achieved. As a result, skin can grow together more quickly,
resulting in shorter post-surgery healing time. Inserting staples
at an insertion angle of about 10.degree. also allows the anvil tab
40A of the anvil 40 to disengage the staple more easily, causing
less trauma to the wound site.
[0069] The stapling device of the present invention comes to the
clinician in assembled, loaded and sterilized form. Grasping the
device in his or her right or left hand by rearward handle portion
10C and with his or her fingers about trigger member 12 as shown in
FIG. 1, the clinician locates the instrument over the wound or
incision to be sutured. This is illustrated in FIGS. 9-12 wherein a
patient's skin surface 104 is shown containing a wound or incision
106, FIG. 10.
[0070] As best shown in FIGS. 9 and 10, the staples of the staple
stack 72 are of a channel configuration, with a substantially
straight crown portion 100 connecting two 90.degree. elbow regions,
from which vertically extend sharpened point prongs or staple legs
112 and 114.
[0071] Once the device is properly located over incision 106, FIG.
10, the clinician squeezes trigger member 12 against the action of
leaf spring member 48 as shown in FIGS. 1 and 2. As indicated
heretofore, pivoting of trigger member 12 in a counterclockwise
direction (as viewed in FIGS. 1 and 2) will cause the nose portion
12B of trigger member 12 to shift staple former 44 to its second
extended or staple-forming position. As the staple former 44 shifts
downwardly, its lowermost edges 44G and 44H, FIGS. 9-11, will
contact the crown portion 100 of lead staple 64 to either side of
tab 40A of anvil member 40. As the staple former 44 moves further
downward, the curved portions 44E and 44F of prongs 44C and 44D
will initiate bending of the crown portion 100 of the lead staple
64. Bending may be assisted by tooling marks 108 and 110. This, in
turn, will cause staple legs 112 and 114 to enter and be implanted
in the skin surface 104, FIGS. 10-11. At the completion of the
forming and implanting procedure, the staple will have the
configuration shown in FIG. 11, closing incision 106, FIG. 10. It
is contemplated to include in an embodiment of the invention a
pre-cock position at which point a detent engages and prevents
return of the trigger member as described in U.S. Pat. No.
4,669,647 issued to Storace, relevant portions of which relating to
a pre-cock position are incorporated herein by reference.
[0072] In this configuration, the fully formed and implanted staple
116 is in its post-implantation configuration and is now of such
dimension that it can slide off anvil member 40. Upon release of
trigger member 12, leaf spring member 48 will return the trigger
member to its normal position as shown in FIG. 1. This, in turn,
will cause staple former 44 to return to its first retracted or
at-rest position. In the meantime, spring 90 and feeder shoe 74
(see FIGS. 15, 18 and 19) will advance the next forwardmost staple
of staple stack 72 against the tabs 50J and 50K. As best shown in
FIGS. 7 and 17, tabs 50J and 50K align lead staple 64 with first
openings 50C and 50D.
[0073] Modifications may be made in the invention without departing
from the spirit of it. For example, leaf spring member 48 can be
replaced by a compression spring or any other appropriate type of
biasing means.
[0074] The foregoing disclosure and description of the invention
are illustrative and explanatory thereof, but to the extent
foreseeable, the spirit and scope of the invention are defined by
the appended claims.
* * * * *