Barbed surgical staple

Information

  • Patent Grant
  • 10226247
  • Patent Number
    10,226,247
  • Date Filed
    Friday, May 6, 2016
    8 years ago
  • Date Issued
    Tuesday, March 12, 2019
    5 years ago
Abstract
An exemplary surgical staple may include a base including a first end and a second end; a single tine extending from the second end of the base; and a barb extending from the base at a location between the first end of the base and the second end of the base. An end of such a staple may be frangibly affixed to a feeder belt. Another exemplary surgical apparatus may include at least one staple including a base including a first end and a second end, a first tine extending from the second end of the base, and a second tine extending from the base at a location between the first end of the base and the second end of the base.
Description
FIELD OF THE INVENTION

The invention generally relates to surgical staplers and stapling.


BACKGROUND

An endocutter is a surgical tool that staples and cuts tissue to transect that tissue while leaving the cut ends hemostatic. An endocutter is small enough in diameter for use in minimally invasive surgery, where access to a surgical site is obtained through a trocar, port, or small incision in the body. A linear cutter is a larger version of an endocutter, and is used to transect portions of the gastrointestinal tract. A typical endocutter receives at its distal end a disposable single-use cartridge with several rows of staples, and includes an anvil opposed to the cartridge. During actuation of an endocutter, the cartridge fires all of the staples that it holds. In order to deploy more staples, the endocutter must be moved away from the surgical site and removed from the patient, after which the old cartridge is exchanged for a new cartridge. The endocutter is then reinserted into the patient. However, it can be difficult and/or time-consuming to located the surgical site after reinsertion. Further, the process of removing the endocutter from the patient after each use, replacing the cartridge, and then finding the surgical site again is tedious, inconvenient and time-consuming, particularly where a surgical procedure requires multiple uses of the endocutter.


In order to overcome these difficulties, Cardica, Inc. of Redwood City, Calif. has developed a true multi-fire endocutter that is capable of firing multiple times without the need to utilize single-use-cartridges. Such an endocutter is described in, for example, U.S. Patent Application Publication No. 2009/0065552, published on Mar. 12, 2009 (the “Endocutter Publication”), which is hereby incorporated by reference herein in its entirety.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 is a side view of a barbed surgical staple in an open state.



FIG. 2 is a side view of the staple of FIG. 1 in a closed state.



FIG. 3 is a side cross-section view of the closed staple of FIG. 2 in tissue.



FIG. 4 is a side view of another embodiment of a surgical staple in an open state.



FIG. 5 is a side view of the staple of FIG. 4 in a closed state.



FIG. 6 is a side view of an exemplary anvil pocket usable with the staple of FIG. 4, as viewed along line A-A of FIG. 7.



FIG. 7 is a top view of the exemplary anvil pocket of FIG. 6.





The use of the same reference symbols in different figures indicates similar or identical items.


DETAILED DESCRIPTION

Referring to FIG. 1, an exemplary surgical staple 2 may include a base 4 and a single tine 6 extending from an end of the base 4. The base 4 may have a first end 8 and a second end 10, and the tine 6 may extend from the second end 10 of the base 4. Alternately, the tine 6 may extend from a location near an end of the base 4, or from a different location on the base 4 entirely. The surgical staple 2 may be independent of other staples or carriers, or may be frangibly affixed to a feeder belt in the same manner as set forth in the Endocutter Publication. If so, the first end 8 of the base 4 may be frangibly attached to the feeder belt, and the second end 10 of the base may be connected to the tine 6. Advantageously, the surgical staple 2 is fabricated from a single piece of material, such as stainless steel. However, the surgical staple 2 may be fabricated from multiple independent components that are connected together in any suitable manner. The tine 6 may include a free end 12, and an opposite end 14 that is connected to the second end 10 of the base 4. The free end 12 of the tine 6 may be sharpened to facilitate entry into tissue. However, the tine 6 may be small enough in cross-section and size that its free end need not be sharpened in order to penetrate tissue. The tine 6 may be curved in a direction both outward from the base 4 and toward the first end 8 of the base 4, as shown in FIG. 1, such that the free end 12 of the tine 6 may be spaced apart from the first end 8 of the base 4 but positioned longitudinally at a location substantially the same as the first end 8 of the base 4. As used in the description of the staple 2, without limitation as to the orientation of the staple 2 in used, the “longitudinal” direction refers to the direction along which the base 4 extends. If the base 4 is curved, the longitudinal direction refers to the direction along a straight line that connects the ends 8, 10 of the base 4.


A barb 16 may extend from the base 4 at a location between its ends 8, 10. The barb 16 has a free end 18 and an opposite end 20 that is connected to the base 4. The free end 18 of the barb 16 may be sharpened to facilitate entry into tissue. However, the barb 16 may be small enough in cross-section and size that its free end need not be sharpened in order to penetrate tissue. The barb 16 is shorter in length than the tine 6. As a result, it is more resistant to deformation. The length of the barb 16 may be selected to minimize or prevent deflection of the barb 16 during deployment of the staple 2, as described in greater detail below. The barb 16 may be curved in a similar manner as the tine 6, in a direction outward from the base 4 and toward the first end 8 of the base 4, as shown in FIG. 1.


Referring also to FIG. 2, the staple 2 is shown in a closed state. Deployment and closure of the staple 2 may be performed substantially as set forth in the Endocutter Publication. To summarize, a wedge may contact the staple directly, urge the tine 6 against an anvil, and cause the free end 12 of the tine 6 to bend toward the first end 8 of the base 4. At the same time, the staple 2 as a whole is rotated about the junction between the first end 8 of the base 4 and the feeder belt to which the first end 8 of the base 4 is affixed. This rotation breaks the staple 2 from the feeder belt after the staple 2 has closed. In the closed state, the free end 12 of the tine 6 is closer to the base 4 than in the open state. As shown in FIG. 2, the free end 12 of the tine 6 may contact the base 4 in the closed state, but the free end 12 of the tine 6 need not contact the base 4 when the staple 2 is closed. In the closed state, the free end 18 of the barb 16 may be closer to the tine 6 than in the open state. The free end 18 of the barb 16 may contact the tine 6 in the closed state, but need not do so. Contact between the free end 18 of the barb 16 and the tine 6 may cause deformation of the barb 16. Alternately, the barb 16 is stiff enough, and/or the staple 2 is closed in such a manner, that the barb 16 substantially does not deform in the closed state. Referring also to FIG. 3, in the closed state, the staple 2 traps tissue 20 between the base 4 and the tine 6. The base 4 is positioned on one side of tissue 20; the tine 6 may extend through that layer of tissue 20 to its other side, then back into that layer of tissue 20 to come into proximity to the base 4. The barb 16 may extend into but not completely through the layer of tissue 20, contacting the tine 6 or coming into proximity to the tine 6 in order to better trap and hold tissue 20 between the tine 6 and the base 4 when the staple 2 is in the closed state.


Referring to FIG. 4, another example of a surgical staple 2 is shown. The base 4 and the tine 6 of this staple 2 are substantially as set forth with respect to FIGS. 1-3 above. Instead of a barb 16, a second tine 22 extends from the base 4 between the tine 6 and the first end 8 of the base 4. The second tine 22 is longer than the barb 16 and shorter than, or substantially the same length as, the tine 6. Alternately, the second tine 22 may be longer than the tine 6. The second tine 22 may have a free end 24 and an opposite end 26 that is connected to the base 4. The free end 24 of the second tine 22 may be sharpened to facilitate entry into tissue. However, the second tine 22 may be small enough in cross-section and size that its free end need not be sharpened in order to penetrate tissue. The second tine 22 may be curved in a direction both outward from the base 4 and toward the first end 8 of the base 4, as shown in FIG. 4, such that the free end 24 of the second tine 22 may be spaced apart from the first end 8 of the base 4 but positioned longitudinally at a location substantially the same as the first end 8 of the base 4. The tine 6 may be curved in a direction both outward from the base 4 and toward the first end 8 of the base 4, as shown in FIG. 4, such that the free end 12 of the tine 6 may be spaced apart from the first end 8 of the base 4 but positioned longitudinally between the free end 24 of the second tine 24 and the second end 10 of the tine 6. Both the tine 6 and second tine 22 may possess substantially the same degree and shape of curvature. However, the tine 6 and second tine 22 need not be curved in the same manner.


Referring also to FIG. 5, the staple of FIG. 4 may be closed by urging the tine 6 and second tine 22 into a staple pocket in an anvil, as set forth in the Endocutter Publication. Due to the curvature of the tines 6, 22, they close in the same direction, rather than in opposite directions. As a result, a substantially “B-shaped” configuration of the closed staple 2 may result, where one-half of the B is oriented in the opposite direction from that of a conventional surgical staple. The tines 6, 22 of the staple 2 of FIG. 5 are sized and shaped such that they do not substantially interfere with one another.


Alternately, the tines 6, 22 may be sized, shaped and/or otherwise configured to contact one another during closure, such as to provide added deformation of one or more tines 6, 22. Alternately, the tine 6 may be laterally offset from the second tine 22 to prevent contact between the two. Referring to FIGS. 6-7, a staple pocket 30 may be defined in an anvil 32, where each staple pocket 30 corresponds to a single staple 2. Each staple pocket 30 may include two sub-pockets 34, each corresponding to a different tine 6, 22 of the staple 2. Engagement between each tine 6, 22 and its corresponding sub-pocket 34 deforms the tines 6, 22 to close in the same direction. The tines 6, 22 may be laterally offset from one another, such that the sub-pockets 34 are laterally offset from one another as seen in FIG. 7. In this way, the tines 6, 22 can close without interference with one another, in the event that the tine 6 is long enough to close onto the second tine 22 if the tines 6, 22 were not offset.


While the invention has been described in detail, it will be apparent to one skilled in the art that various changes and modifications can be made and equivalents employed, without departing from the present invention. It is to be understood that the invention is not limited to the details of construction, the arrangements of components, and/or the steps of performing anastomosis set forth in the above description or illustrated in the drawings. Therefore, the invention is not to be restricted or limited except in accordance with the following claims and their legal equivalents.

Claims
  • 1. A surgical stapling apparatus, comprising: a staple holder configured to hold staples;a plurality of staples contained within said staple holder, wherein one of the plurality of staples comprising: a base including a first end and a second end, wherein said first end configured to frangibly detach from an attachment contained within said staple holder; andtwo tines extending from said base, wherein a first tine extends from said second end of said base and wherein a second tine extends from a location between said first tine and said first end of said base; andan anvil configured to deform said plurality of staples as said plurality of staples are deployed.
  • 2. The surgical stapling apparatus of claim 1, wherein said first tine and said second tine are substantially of equal lengths.
  • 3. The surgical stapling apparatus of claim 1, wherein said first tine and said second tine are positioned or oriented laterally offset relative to one another.
  • 4. The surgical stapling apparatus of claim 1, wherein said anvil includes at least one staple forming pocket.
  • 5. The surgical stapling apparatus of claim 4, wherein at least one said staple forming pocket includes two sub-pockets.
  • 6. The surgical stapling apparatus of claim 5, wherein said two sub-pockets being positioned or oriented laterally offset relative to one another.
  • 7. The surgical stapling apparatus of claim 5, wherein said sub-pockets configured to cause both said first tine and said second tine to deform or close upon contact between said staple and a corresponding staple forming pocket of said anvil.
  • 8. The surgical stapling apparatus of claim 1, wherein said attachment being coupled or connected to said staple holder.
  • 9. The surgical stapling apparatus of claim 1, wherein said attachment being coupled to or connected to a staple feeder belt contained at least partially within said staple holder.
US Referenced Citations (113)
Number Name Date Kind
3581551 Wilkinson Jun 1971 A
3650453 Smith Mar 1972 A
3675688 Bryan et al. Jul 1972 A
3899914 Akiyama Aug 1975 A
3955581 Spasiano et al. May 1976 A
4086926 Green et al. May 1978 A
4228895 Larkin Oct 1980 A
4275813 Noiles Jun 1981 A
4475679 Fleury Oct 1984 A
4589416 Green May 1986 A
4633861 Chow et al. Jan 1987 A
4655222 Florez et al. Apr 1987 A
4719917 Barrows et al. Jan 1988 A
4762260 Richards et al. Aug 1988 A
4969591 Richards et al. Nov 1990 A
4978049 Green Dec 1990 A
5156315 Green et al. Oct 1992 A
5170925 Madden et al. Dec 1992 A
5192288 Thompson et al. Mar 1993 A
5307976 Olson et al. May 1994 A
5413272 Green et al. May 1995 A
5476206 Green et al. Dec 1995 A
5547117 Hamblin et al. Aug 1996 A
5553765 Knodel et al. Sep 1996 A
5620289 Curry Apr 1997 A
5630541 Williamson et al. May 1997 A
5655698 Yoon Aug 1997 A
5662260 Yoon Sep 1997 A
5692668 Schulze et al. Dec 1997 A
5810855 Rayburn et al. Sep 1998 A
5816471 Plyley et al. Oct 1998 A
5843084 Hart Dec 1998 A
5855311 Hamblin et al. Jan 1999 A
5871135 Williamson et al. Feb 1999 A
5875538 Kish et al. Mar 1999 A
5894979 Powell Apr 1999 A
5918791 Sorrentino et al. Jul 1999 A
5964774 McKean et al. Oct 1999 A
6254615 Bolduc Jul 2001 B1
6306149 Meade et al. Oct 2001 B1
6391038 Vargas et al. May 2002 B2
6419682 Appleby et al. Jul 2002 B1
6592597 Grant et al. Jul 2003 B2
6602252 Mollenauer Aug 2003 B2
6716232 Vidal et al. Apr 2004 B1
6817508 Racenet et al. Nov 2004 B1
6843403 Whitman Jan 2005 B2
6939358 Palacios et al. Sep 2005 B2
7025747 Smith Apr 2006 B2
7055730 Ehrenfels et al. Jun 2006 B2
7097089 Marczyk Aug 2006 B2
7111768 Cummins et al. Sep 2006 B2
7128253 Mastri et al. Oct 2006 B2
7140527 Ehrenfels et al. Nov 2006 B2
7168604 Milliman et al. Jan 2007 B2
7172104 Scirica et al. Feb 2007 B2
7179267 Nolan et al. Feb 2007 B2
7207471 Heinrich et al. Apr 2007 B2
7213736 Wales et al. May 2007 B2
7225963 Scirica Jun 2007 B2
7225964 Mastri et al. Jun 2007 B2
7234624 Gresham et al. Jun 2007 B2
7238195 Viola Jul 2007 B2
7258262 Mastri et al. Aug 2007 B2
7401720 Durrani Jul 2008 B1
7407077 Ortiz et al. Aug 2008 B2
7434715 Shelton et al. Oct 2008 B2
7467740 Shelton et al. Dec 2008 B2
7481347 Roy Jan 2009 B2
7497865 Willis et al. Mar 2009 B2
7506791 Omaits et al. Mar 2009 B2
7517356 Heinrich Apr 2009 B2
7588177 Racenet Sep 2009 B2
7604151 Hess et al. Oct 2009 B2
7631793 Rethy et al. Dec 2009 B2
7635073 Heinrich Dec 2009 B2
7635373 Ortiz Dec 2009 B2
7641432 Lat et al. Jan 2010 B2
7644848 Swayze et al. Jan 2010 B2
7686200 Peterson Mar 2010 B2
7722610 Viola et al. May 2010 B2
7726537 Olson et al. Jun 2010 B2
7753922 Starksen Jul 2010 B2
7794471 Bender et al. Sep 2010 B1
7828189 Holsten et al. Nov 2010 B2
7837079 Holsten et al. Nov 2010 B2
7896895 Boudreaux et al. Mar 2011 B2
7988026 Knodel et al. Aug 2011 B2
8056789 White et al. Nov 2011 B1
8220690 Hess et al. Jul 2012 B2
8662369 Manoux et al. Mar 2014 B1
9332985 Manoux May 2016 B2
20030120284 Palacios et al. Jun 2003 A1
20030236551 Peterson Dec 2003 A1
20050033329 Bombard et al. Feb 2005 A1
20050055087 Starksen Mar 2005 A1
20050154406 Bombard et al. Jul 2005 A1
20050184121 Heinrich et al. Aug 2005 A1
20060011699 Olson et al. Jan 2006 A1
20060041273 Ortiz et al. Feb 2006 A1
20060151567 Roy Jul 2006 A1
20060253143 Edoga et al. Nov 2006 A1
20060278679 Viola et al. Dec 2006 A1
20070027472 Hiles et al. Feb 2007 A1
20070034668 Holsten et al. Feb 2007 A1
20070073341 Smith et al. Mar 2007 A1
20070083234 Shelton et al. Apr 2007 A1
20070118163 Boudreaux et al. May 2007 A1
20070125828 Rethy et al. Jun 2007 A1
20070175950 Shelton et al. Aug 2007 A1
20080078807 Hess et al. Apr 2008 A1
20080272175 Holsten et al. Nov 2008 A1
20090065552 Knodel et al. Mar 2009 A1
Foreign Referenced Citations (7)
Number Date Country
1238634 Sep 2002 EP
1464287 Oct 2004 EP
1736104 Mar 2009 EP
2005160933 Jun 2005 JP
2080833 Jun 1997 RU
8101953 Jul 1981 WO
8501427 Apr 1985 WO
Non-Patent Literature Citations (12)
Entry
Written Opinion for International Application No. PCT/US2008/075449, dated Apr. 29, 2009—5 pages 2018.
Gong, S., “Perfectly Flexible Mechanism and Integrated Mechanism System Design”, Mechanism and Machine Theory 39(2004), (Nov. 2004)—pp. 1155-1174 2018.
Lim et al., “A Review of Mechanism Used in Laparascopic Surgical Instruments”, Mechanism and Machine Theory 38, (2003)—pp. 1133-1147 2018.
Lim, J., “Type Synthesis of a Complex Surgical Device”, Master Thesis, (Feb. 21, 2001) 2018.
Lim et al., “Application of Type Synthesis Theory to the Redesign of a Complex Surgical instrument”, Journal of Biomechanical Engineering (124), (Jun. 2004)—pp. 265-274 2018.
Kolios et al., “Microlaparoscopy”, J. Endourology 18(9), (Nov. 2004)—pp. 811-817 2018.
Steichen et al., “Mechanical Sutures in Surgery”, Brit. J. Surg. 60(3), (Mar. 1973)—pp. 191-197 2018.
Notification of the Transmittal of the International Search Report and the Written Opinion of the International Searching Authority, PCT/US2008/075449 2018.
International Search Report, PCT/US2008/075449 2018.
Cardica Microcutter Implant Delivery Device 510(k), Cover Sheet, Table 10.1, “Substantial Equivalence Comparison”, and Section 12, “Substantial Equivalence Discussion” 2018.
Entire patent prosecution history of U.S. Appl. No. 12/788,911, filed May 27, 2010, entitled “ Barbed Surgical Staple,” now U.S. Pat. No. 8,662,369, dated Mar. 4, 2014.
Entire patent prosecution history of U.S. Appl. No. 14/191,073, filed Feb. 26, 2014, entitled “Barbed Surgical Staple,” now U.S. Pat. No. 9,332,985, dated May 10,2016.
Related Publications (1)
Number Date Country
20160249913 A1 Sep 2016 US
Continuations (2)
Number Date Country
Parent 14191073 Feb 2014 US
Child 15148730 US
Parent 12788911 May 2010 US
Child 14191073 US