This application is the U.S. national stage application of International Application No. PCT/IE02100119, filed Aug. 8, 2002, entitled “Surgical Stapling Device,” which designated the United States and was in the English language, and which claims priority to Ireland Application No. S200110749, filed Aug. 9, 2001, entitled “Surgical Stapling Device.” These applications are expressly incorporated by reference herein.
This invention relates to a surgical stapling device.
Surgical stapling devices have been in existence for many years. They are routinely used in surgical procedures mainly for the purposes of effecting a wound closure. Some of the most popular applications include closing a skin incision and end-to-end or end-to-side anastomosis of internal (generally tubular) vessels such as the large bowel, etc. Current staplers are designed to deliver one or more staples in a serial fashion or a number of staples in one shot. Skin staplers, for example, deliver 30 or more staples in a serial fashion. The staples are stacked within the device and during the firing operation one staple is advanced from the stack and delivered through the head of the device. During the following cycle another staple is advanced from the top of the stack and again delivered through the head of the device and so on. In one shot devices such as a bowel anastomosis stapler the staples are prearranged in a linear or circular fashion and upon activation of the device all the staples are delivered through the head. Examples of existing prior art as described above include U.S. Pat. Nos. 4,592,498, 5,289,963, 5,433,721 and 5,470,010.
The mechanism involved in forming a staple and releasing it from its forming mechanism is common to the majority of surgical stapler devices. Generally the components include an anvil, a staple closing actuator, and a staple release mechanism. The anvil is normally positioned in front of the staple and the actuator directly behind the staple. As the actuator advances the staple against the anvil the back section of the staple deforms around both ends of the anvil thereby transforming the staple from a generally U-shape to a generally rectangular shape. At this point the actuator generally retracts and the staple is released from the anvil either as a result of the anvil moving out of position and allowing the staple to move forward, or alternatively ejecting the staple over the anvil thereby releasing it from the device.
A mechanism such as that described above, used in conjunction with a blood location tube, is described in Irish Patent Application S2000/0722. This describes a stapling device which has a generally oval cross-section blood locator tube that protrudes ahead of the device. The function of the blood locator tube is to track down over a guidewire through the tissue and into the opening in the artery. Once in the artery, blood flows back up one side of the locator tube and exits the device outside the body where the operator can see it. This indicates to the operator that the device is in place and it is safe to operate. This patent application also describes a specially designed staple (humpback staple) which wraps around the locator tube so that it can be deployed centrally across the radial opening in the artery. The benefits of using an oval locator tube and a humpback staple are that the staple is located centrally in the artery and hence the staple used need not be so large, and in turn, the dimensions of the shaft, which must accommodate the staple when in its unformed state, can be reduced, leading to less trauma to the tissue into which the shaft is introduced. A further consequence of having a generally oval or elongated cross section for the locator tube is that the tube will be more disposed to the center of the puncture than with a rounded tube. The device has a staple that straddles the locator tube, thereby increasing the likelihood of the staple closing the elongated wound at its center rather than towards one or other of the extremities of the wound.
The above device using a humpback staple has a number of disadvantages. When compared to conventional straight backed staples it can be appreciated that as the staple is formed around the anvil, the back is placed under tension, tending to cause the hump to collapse. In addition, because of the presence of the blood locator tube the anvil is reduced to individual fingers which tend to collapse inward due to lack of central support.
Furthermore, because of the position of the locator tube the staple former must be generally U-shaped in section so as to straddle it. Because of this the working fingers have a tendency to spread outward during the forming process.
It is an object of the invention to provide an improved surgical stapling device in which these disadvantages are avoided or mitigated, while retaining the benefits of centrally positioning the staple across the radial tear.
The present invention provides a surgical stapling device that generally includes an elongate housing having a free forward end, a surgical staple slidable longitudinally within the housing towards the forward end thereof and having a back and two forwardly pointing legs, a staple-firing mechanism for driving the staple towards the forward end of the housing, bending the staple to bring the free ends of the legs towards one another to close the staple, and releasing the closed staple, and an elongated locator member slidable longitudinally within the housing between an initial extended position wherein a forward end of the locator member projects beyond the forward end of the housing to enter a puncture site in a liquid-carrying vessel in a human or animal, thereby to locate the forward end of the housing at the puncture site, and a retracted position wherein the locator member is retracted into the housing in coordination with the closure of the staple. The locator member can also include a longitudinal slot extending rearwardly from its forward end partially along the length of the locator member. The slot allows the back of the staple to be accommodated transversely therein with its forwardly pointing legs disposed externally of and respectively on opposite sides of the locator member.
This object is achieved by the invention claimed in the appended claims.
An embodiment of the invention will now be described, by way of example, with reference to the accompanying drawings, in which:
Referring initially to
The blood locator tube 18 is, except for a longitudinal slot 20, of substantially the same construction as that described in Irish Patent Application S2000/0722. Thus it has a generally oval cross-section at the distal end and is slidable longitudinally within the housing 10 between an initial extended position (
The tube 18 serves two purposes. In use it is tracked along a guidewire (not shown) to bring the front end of the housing 10 to the site of a puncture wound, and it allows blood to flow back along the housing to the handle to permit the operator to see when the forward end of the housing has penetrated the wound. This is as described in Irish Patent Application S2000/0722. However, in the present embodiment the tube 18 has a longitudinal slot 20 extending rearwardly from its forward end partially along the length of the locator member. In this embodiment the slot 20 is about 5 mm long. A pair of inwardly bent tabs 22 at the front end of the tube 18 confine the guidewire to the region of the tube below the slot 20 (referring to the orientation seen in the drawings), to avoid the guidewire interfering with the movement of the staple and actuator within the slot, to be described.
The actuator 16 is an elongated member having a forward end which is forked to provide two arms 16a connected by a transverse bridge 16b. The bridge 16b extends transversely through the slot 20 with the arms 16a extending forwardly on either side of the tube 18. The rear of the actuator 16 comprises a pair of opposed part-cylindrical shells 16c which slidably embrace the tube 18 to allow the actuator 16 to slide longitudinally thereon.
The staple 14 is a standard, generally U-shaped staple having a straight back 14a and two forwardly pointing legs 14b. The free ends of the staple legs 14b are sharpened for ease of tissue penetration. In use of the device the back 14a of the staple is accommodated transversely in the slot 20 with its forwardly pointing legs 14b disposed externally of and respectively on opposite sides of the tube 18.
The device further includes an anvil 24. This is made out of stamped and bent metal sheet and comprises a pair of opposite parallel side plates 24a each with a laterally extending wing 24b, and a bridge element 24c joining the font ends of the side plates 24a. In use of the device the anvil 24 is fixed by its wings 24b in a recess 26 in lower housing half 18b with the side plates 24a disposed respectively on opposite sides of the tube 18 and the bridge element 24c extending transversely through the slot 20 in front of the staple 14. The bridge element 24c is substantially flush with the front surface of the housing 10. Finally, a pair of staple ejection springs 28 have their rear ends fixed respectively to the wings 24b and their free front ends, when unrestrained, extending upwardly above the level of the bridge element 24c.
The operation of the device will now be described with reference to
In the initial configuration of the device,
Upon operation of the trigger previously mentioned, or other operating mechanism, the actuator 16 is driven forwardly towards the free forward end of the housing 10. This drives the staple 14 before it by engagement of the actuator arms 16a with the outer portions of the staple back 14a. During such forward movement the staple deflects the free ends of the ejection springs 28 downwardly. At the same time the blood locator tube 18 starts to be retracted in coordination with the movement of the staple.
Deformation of the staple is about to take place at this stage.
Upon further forward movement of the actuator 16,
Finally,
The benefits of the foregoing embodiment over the device described in Irish Patent Application S2000/0722 are:
a. A standard straight legged staple can be used. This will deform in a more predictable manner, it is less expensive to manufacture and is less likely to become caught in the anvil or shaft.
b. As the staple used is straight there is less risk that the staple will open up and create a “lazy” staple effect.
c. A larger blood locator tube can be used for ease of manufacture and increased blood flow for better indication of position.
d. Stronger and easier to manufacture anvil due to the transverse bridge.
e. Bridge between forming components of former to prevent spreading during the staple forming process.
Also it is possible to define a configuration which incorporates not one but two staples. Both staples would be located in respective slots on either side of the blood locator tube. A configuration such as this allows for the passage of a component such as a guidewire between both staples that would facilitate the process of blindly locating puncture holes in vessels.
The invention is not limited to the embodiment described herein and may be modified or varied without departing from the scope of the invention.
| Number | Date | Country | Kind |
|---|---|---|---|
| S2001/0749 | Aug 2001 | IE | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IE02/00119 | 8/8/2002 | WO | 00 | 2/6/2004 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO03/013364 | 2/20/2003 | WO | A |
| Number | Name | Date | Kind |
|---|---|---|---|
| 3482428 | Kapitanov et al. | Dec 1969 | A |
| 4014492 | Rothfuss | Mar 1977 | A |
| 4523695 | Braun et al. | Jun 1985 | A |
| 4724840 | McVay et al. | Feb 1988 | A |
| 4771782 | Millar | Sep 1988 | A |
| 4789090 | Blake, III | Dec 1988 | A |
| 4934364 | Green | Jun 1990 | A |
| 5108421 | Fowler | Apr 1992 | A |
| 5131379 | Sewell, Jr. | Jul 1992 | A |
| 5147381 | Heimerl et al. | Sep 1992 | A |
| 5192300 | Fowler | Mar 1993 | A |
| 5275616 | Fowler | Jan 1994 | A |
| 5292309 | Van Tassel et al. | Mar 1994 | A |
| 5292332 | Lee | Mar 1994 | A |
| 5306254 | Nash et al. | Apr 1994 | A |
| 5395030 | Kuramoto et al. | Mar 1995 | A |
| 5431639 | Shaw | Jul 1995 | A |
| 5443481 | Lee | Aug 1995 | A |
| 5470010 | Rothfuss et al. | Nov 1995 | A |
| 5478352 | Fowler | Dec 1995 | A |
| 5527322 | Klein et al. | Jun 1996 | A |
| 5536251 | Evard et al. | Jul 1996 | A |
| 5560532 | DeFonzo et al. | Oct 1996 | A |
| 5591205 | Fowler | Jan 1997 | A |
| 5601602 | Fowler | Feb 1997 | A |
| 5620461 | Muijs Van De Moer et al. | Apr 1997 | A |
| 5643318 | Tsukernik et al. | Jul 1997 | A |
| 5645566 | Brenneman et al. | Jul 1997 | A |
| 5674231 | Green et al. | Oct 1997 | A |
| 5676689 | Kensey et al. | Oct 1997 | A |
| 5716375 | Fowler | Feb 1998 | A |
| 5725554 | Simon et al. | Mar 1998 | A |
| 5810846 | Virnich et al. | Sep 1998 | A |
| 5855312 | Toledano | Jan 1999 | A |
| 5861005 | Kontos | Jan 1999 | A |
| 6004341 | Zhu et al. | Dec 1999 | A |
| 6007563 | Nash et al. | Dec 1999 | A |
| 6022372 | Kontos | Feb 2000 | A |
| 6048358 | Barak | Apr 2000 | A |
| 6056768 | Cates et al. | May 2000 | A |
| 6090130 | Nash et al. | Jul 2000 | A |
| 6197042 | Ginn et al. | Mar 2001 | B1 |
| 6277140 | Ginn et al. | Aug 2001 | B1 |
| 6322580 | Kanner | Nov 2001 | B1 |
| 6348064 | Kanner | Feb 2002 | B1 |
| 6506210 | Kanner | Jan 2003 | B1 |
| 6533762 | Kanner et al. | Mar 2003 | B1 |
| 6623510 | Carley et al. | Sep 2003 | B1 |
| 6719777 | Ginn et al. | Apr 2004 | B1 |
| 6755842 | Kanner et al. | Jun 2004 | B1 |
| 6767356 | Kanner et al. | Jul 2004 | B1 |
| 20020049472 | Coleman | Apr 2002 | A1 |
| 20020151921 | Kanner et al. | Oct 2002 | A1 |
| 20030097140 | Kanner | May 2003 | A1 |
| 20030109890 | Kanner et al. | Jun 2003 | A1 |
| 20040010285 | Carley et al. | Jan 2004 | A1 |
| 20040254591 | Kanner et al. | Dec 2004 | A1 |
| 20040267312 | Kanner et al. | Dec 2004 | A1 |
| Number | Date | Country |
|---|---|---|
| 0 386 361 | Sep 1990 | EP |
| 0 534 696 | Mar 1993 | EP |
| 0 756 851 | Feb 1997 | EP |
| 0 774 237 | May 1997 | EP |
| 0 941 697 | Sep 1999 | EP |
| 2 443 238 | Jul 1980 | FR |
| 1 358 466 | Jul 1974 | GB |
| WO 9720505 | Jun 1997 | WO |
| WO 9817179 | Apr 1998 | WO |
| WO 9825508 | Jun 1998 | WO |
| WO 0056227 | Sep 2000 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 20040236355 A1 | Nov 2004 | US |