US20060100649A1 - Surgical staple-clip and applier - Google Patents

Abstract

A surgical staple-clip including a clip component and a securing member is used in a wide range of surgical procedures. The staple-clip may be introduced to a surgical site in an un-assembled condition through a small port or trocar. An applier for the staple-clip comprising a pair of opposed jaw-like channels is provided to position and apply the clip component and the securing member. The clip component is positioned around a target tissue and is compressed or clamped upon the tissue using only the force required for a specific surgical procedure such as occlusion, ligation or fixation. When the clip component is properly applied, the securing member is urged forward and over the clip component to secure the staple-clip. The clip component may include traction enhancement features such as surface interruptions, bumps, valleys and ridges. With the staple-clip of the invention, the force required to constrict or occlude the tissue is separate from the force required to secure and maintain the staple-clip in position and, as a result, the body tissue is not over-compressed and nourishment to the body tissue is maintained. Other aspects of the invention include thumb actuated clip appliers for use in hand assisted laparoscopy (HAL). In one embodiment, a clip applier includes a handle and a thumb actuated mechanism that is used to slidably release clips onto a body tissue or vessel by sliding the thumb actuated mechanism forward and backward using only one hand. In another aspect of the invention, a two-stage clip is disclosed having a clip component and a staple component for securing the clip after it has been properly positioned.

Description

• This is a non-provisional application claiming the priority of provisional application Ser. No. 60/434,344, filed on Dec. 17, 2002, entitled “Surgical Staple-Clip and Applier,” which is fully incorporated herein by reference.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• This invention generally-relates to medical devices and, more specifically, to a staple-clip and applier adapted for use in surgical procedures.
• 2. Discussion of the Prior Art
• Clips and staples are widely used in many surgical procedures such as occlusion, ligation and fixation of various body tissues and vessels. Clips are generally U-shaped, open-ended wires that are positioned around a target tissue and clamped together to constrict or occlude the tissue. A clip applier is typically used for applying the clips. Clip appliers can be configured for applying a single clip or multiple clips in both open and minimally invasive or laparoscopic surgeries. The individual clips are provided in a loading cartridge or rack of a clip applier. With minimally invasive surgery, a clip applier must be able to deliver clips through a small access port or trocar having a diameter of about 10 mm to 12 mm. Accordingly, the size of a deliverable laparoscopic clip must be smaller than the inside diameter of the trocar through which it is introduced. Typically, a 12 mm clip applier is capable of delivering a clip that is no longer than 7-8 mm. It is not uncommon for laparoscopic surgeons to discover that even the largest clip available is undersized for a particular surgical procedure. Moreover, clips will occasionally move about or slip off the tissue to which they have been applied. In some cases, a surgeon may apply an excessive compressive force to the clip and tissue to minimize movement or slippage of the clip. This excessive compression may cause necrosis of tissue since nutrition to the tissue is interrupted or eliminated.
• Staples are also widely used in many surgical procedures to constrict or occlude,a body tissue or vessel. A surgical staple typically includes a pair of penetrating legs connected by a base portion. Surgical staples are applied using a stapler, which compresses the penetrating legs as the legs advance through the body tissue and are bent against an opposing jaw of the stapler to secure the staple to the body tissue. A feature of the staple is it defines open portions that provide nourishment to the tissue even when the staple is bent. Surgical staples have proved to be effective, however, the staplers used for applying the staples are often bulky and require a very strong closing or compressing force, which is not ideal for minimally invasive or laparoscopic surgeries. As such, it is desirable to find a staple/clip providing good traction to prevent movement and slippage while requiring only a force to close or compress the staple/clip. Specifically, it is desirable to have a staple/clip where the force required to constrict or occlude a body tissue is separate from the force required to secure and maintain the device in position. The staple-clip would provide good traction while maintain proper nourishment to the body tissue. It is advantageous to use the staple/clip, for example, to secure the renal vessel in donor nephrectomy.
SUMMARY OF THE INVENTION
• The present invention is directed to a surgical staple-clip for use in a wide range of surgical procedures. The staple-clip comprises a plurality of individual elements including a clip component and a securing or fixation member connected with the clip component to form a Composite staple-clip. The composite staple-clip may be configured for use in both open and minimally invasive or laparoscopic surgeries. The staple-clip may be introduced to a surgical site in an un-assembled condition through a small port or trocar. An applier for the staple-clip comprising a pair of opposed jaw-like channels is provided to position and apply the clip component and the securing member. The clip component is positioned around a target tissue and is compressed or clamped upon the tissue using only the force required for a specific surgical procedure such as occlusion, ligation or fixation. When the clip component is properly applied and the desired effects are observed, the securing member is urged forward and over the clip component to secure the staple-clip.
• In one aspect of the invention, the clip component includes traction enhancement features including surface interruptions, bumps, valleys, ridges and the like. In another aspect of the invention, the clip component includes tissue-penetrating features similar to those of a staple. It is appreciated that with the staple-clip of the invention, the force required to constrict or occlude the tissue is separate from the force required to secure and maintain the staple-clip in position. That is, only the compressive force needed to perform a specific surgical procedure such as occlusion, ligation or fixation is applied to the body tissue, and the force normally required to secure and maintain a clip of the prior art is not applied since traction and security are supplied by the clip component and securing member of the staple-clip. As a result, the body tissue is not over-compressed and nourishment to the body tissue is maintained.
• Other aspects of the invention include thumb actuated Clip appliers for use in hand assisted laparoscopy (HAL). In one embodiment, a clip applier includes a handle and a thumb actuated mechanism that is used to slidably release clips onto a body tissue or vessel by sliding the thumb actuated mechanism forward and backward using only one hand. This design closes the jaws around the body tissue or vessel and allows a closed clip to slide into position. In another embodiment, a clip is provided having a first arm and a second arm folded over the first arm. The first arm includes a latch mechanism such as an inwardly turned portion or hook at its distal end that is configured to interlock or mate with a distal end of the second arm when the arms are clamped together. The latch mechanism operates in a similar way to a hair clip and responds to thumb pressure. An operator may single-handedly access the clip and slide it onto a body tissue or vessel as needed. The arms of the clip may include tissue-penetrating elements on the inner, opposed faces of the arms.
• In another aspect of the invention, a two-stage clip is disclosed having a clip component and a staple component for securing the clip after it has been properly positioned. The clip component is formed from a first piece of material and includes opposed arms, each of which includes openings allowing penetration of legs of the staple component. The staple component is formed from a second piece of material and is used to puncture a body tissue or vessel and to interlock the clip component. The arms of the clip component may include a latch mechanism at the distal ends to mate with each other when the arms are closed or clamped together. During use, the first stage closes the arms of the clip. After the first stage, the clip can still be safely removed. The second stage secures the clip permanently onto the body tissue or vessel by applying the staple component to the clip component. In another embodiment, a two-stage clip is formed entirely from a single piece of material and includes a first arm and an opposed second arm. The second arm further includes securing elements, all of which are formed as an integral, one-piece construction. With this construction, the securing elements may still remain open after the first stage when the arms are clamped upon a body tissue or vessel. A second action then presses the securing elements into the body tissue or vessel.
• These and other features and advantages of the invention will become more apparent with a discussion of preferred embodiments in reference to the associated drawings.
DESCRIPTION OF THE DRAWINGS
• FIGS.1(a) and1(b) illustrate a typical surgical clip in an open condition and a closed condition, respectively;
• FIG. 2 illustrates the movement and slippage of a typical surgical clip;
• FIGS.3(a) and3(b) illustrate a typical surgical staple in an open condition and a closed condition, respectively;
• FIGS.4(a) and4(b) illustrate a typical arrangement of open and closed surgical staples, respectively;
• FIGS.5(a) and5(b) illustrate a typical surgical clip applier and staple applier, respectively;
• FIG. 6(a) is a perspective view of the clip components and securing member of the staple-clip in accordance with an embodiment of the invention;
• FIG. 6(b) is a perspective view of the assembled staple-clip ofFIG. 6(a);
• FIG. 7 is a perspective view of the assembled staple-clip ofFIG. 6(b) placed upon a body conduit or passage;
• FIG. 8 is a perspective view of the staple-clip and applier configured for use in a minimally invasive surgical procedure;
• FIGS.9(a),9(c),9(e) and9(g) are side views of the staple-clip of the invention in an open, closing, closed and locked condition, respectively;
• FIGS.9(b),9(d),9(f) and9(h) are end views of the staple-clip of FIGS.9(a),9(c),9(e) and9(g), respectively;
• FIGS.10(a) and10(b) are perspective views of a clip in an open and closed condition, respectively, having a monolithic construction in accordance with another embodiment of the invention;
• FIGS.10(c) and10(d) are side views of the clip of FIGS.10(a) and10(b), respectively, having pointed tissue-penetrating elements;
• FIGS.10(e) and10(f) are end views of the clip of FIGS.10(c) and10(d), respectively;
• FIGS.11(a) and11(b) are side views of the staple-clip before and after placement upon a body conduit or passage, respectively;
• FIGS.11(c) and11(d) are end views of the staple-clip of FIGS.11(a) and11(b), respectively;
• FIGS.12(a) and12(b) are schematic side views of a staple-clip applier in a closed and open condition, respectively;
• FIGS.12(c) and12(d) are front, end views of the staple-clip applier of FIGS.12(a) and12(b), respectively;
• FIGS.13(a) and13(b) are perspective views of the tissue contacting face portions of a staple-clip in another aspect of the invention;
• FIG. 14 illustrates the sequence of placing the securing member upon the tissue-engaging members of the staple-clip of the invention;
• FIGS.15(a),15(b) and15(c) illustrate the invention sized and configured to pass through a small trocar port in a first condition, second condition and final condition, respectively;
• FIG. 16 illustrates placement of a single staple-clip of the invention;
• FIG. 17 illustrates parallel placement of the staple-clips of the invention;
• FIG. 18 illustrates parallel placement of the staple-clips of the invention with a cutting element placed between the staple-clips;
• FIG. 19 illustrates a laparoscopic stapler configured for use in donor nephrectomy in accordance with another aspect of the invention;
• FIGS.20(a)-20(e) illustrate various thumb actuated clip appliers for use in hand assisted laparoscopy (HAL) in accordance with additional aspects of the invention;
• FIG. 21 illustrates a spring like coil for suturing a body tissue or vessel in accordance with another aspect of the invention;
• FIG. 22 illustrates a plurality of staples formed from a single piece of material in accordance with another aspect of the invention;
• FIG. 23 illustrates a temporary HAL clamp for use in donor nephrectomy in accordance with another aspect of the invention;
• FIGS. 24-26 illustrate various two-stage staple-clips in accordance with additional aspects of the invention; and
• FIG. 27 illustrates a holder to press a body tissue flat and to provide clearance during placement of a staple-clip having sharp features.
DESCRIPTION OF PREFERRED EMBODIMENTS AND BEST MODE OF THE INVENTION
• FIGS. 1 and 2 illustrate asurgical clip10 of the prior art having a generally open shape including afirst leg15, asecond leg20 and a base30 connecting thefirst leg15 and thesecond leg20. Theclip10 can be positioned around a body conduit or passage, e.g., a blood vessel, and compressed using aclip applier150 as illustrated inFIG. 5(a). Theclip applier150 generally comprises anelongate shaft155, sized and configured to fit through a surgical trocar port, adistal end160 having a pair ofopposed jaws165,167 and aproximal end170 having ahandle180 to open and close thejaws165,167. Theclip10, held in an open condition, is supplied to thejaws165,167 either automatically or manually. Theclip10 is advanced to a desired site and subsequently closed or compressed. With the first andsecond legs15 and20 properly formed, thejaws165,167 can be opened and moved away from the tissue leaving theclip10 clamped around the tissue. Theclip10 derives its strength from the material from which it is made. The material chosen must be sufficiently malleable to allow the clip to be compressed as illustrated inFIG. 1(b) while preventing spring-back of the material after application of a compressive force.
• There are many factors that must be considered in applying a surgical clip to a body tissue or vessel. First, the clip must be sufficiently wide to completely encompass the tissue. As illustrated inFIG. 1(a), theclip10 must have anopen area50 that is wide enough to encompass the target tissue. Second, the clip must be compressible with a reasonable application force, i.e., a force that an operator feels comfortable applying to the body tissue. Third, the clip, once applied, must not move from the location where it was applied. As illustrated inFIG. 2, theclip10 must not slip along axes80(a) or80(b) or slip off ofbody vessel60. A fourth factor is that theclip10 should not compress the body tissue so much that it constricts, interrupts or destroys the nourishment of the tissue. As can be seen, the above factors of clip-based ligation or fixation are difficult to achieve using a single wire-formed clip. Moreover, the issues of compression and traction must be separated if proper nourishment of the tissue is to be preserved while maintaining a secure placement of the clip.
• Surgical staples are another device that is commonly used for occlusion, ligation and fixation of body tissues and vessels. Referring toFIG. 3(a), a typicalsurgical staple100 comprises generally straight, penetratingleg portions110 and120 connected together by abase portion130. As thepenetrating leg portions110,120 are applied to a body tissue or vessel, the leg portions advance through the tissue and are bent against the opposing jaw of the stapler and toward each other as illustrated inFIG. 3(b). The bending of the staple100 forms a confinement of the body tissue that is, for the most part, independent of the compression of the tissue itself.FIG. 5(b) illustrates alaparoscopic stapler190 that operates in much the same way as a clip applier. During use, thestapler190 is advanced over a portion of body tissue and is compressed to deliver at least one, and more often several, penetrating surgical staples. See, for example, FIGS.4(a) and4(b). The compressedsurgical staple100 has a general shape of the capital letter “B” where fluid nourishment of the tissue is provided throughopen portions140 of the foldedstaple100. Surgical staples have proved to be effective and are a standard in surgery. However, the staplers used for applying the staples are often bulky and require a very strong closing or compressing force, which is not ideal for minimally invasive or laparoscopic surgeries. Accordingly, there is a need in the art for a device having features and advantages of both the staple and clip. The staple/clip would provide good traction to prevent the device from moving or dislodging from the body tissue while maintaining proper nourishment to the tissue. In addition, the force required to constrict or occlude the body tissue would be separated from the force required to secure and maintain the device in position. Specifically, the portion of tissue to be treated would not be compressed more than is necessary to achieve the desired result.
• FIG. 6(a) illustrates a surgical staple-clip200 in accordance with a first embodiment of the invention. The staple-clip200 comprises a first tissue-engagingmember205, a second tissue-engagingmember210 opposed to the first tissue-engagingmember205, and a securing orfixation member220 for securing the first and second tissue-engagingmembers205,210. The first tissue-engagingmember205 comprises generally opposedwalls230,232 and a connectingwall234 that together define anelongate channel236. The second tissue-engagingmember210 is similar to the first tissue-engagingmember205 and comprises generally opposedwalls240,242 and a connectingwall244 that together define anelongate channel246. The tissue-engagingmembers205,210 are normally held such that the front faces of the connectingwalls234,244, respectively, are opposed to each other. The opposing front faces of the connectingwalls234,244 may include a plurality of tissue-penetratingelements238,248, respectively.
• An advantage of the staple-clip of the invention is it provides good traction without requiring an excessive compressive force to be applied to the staple-clip. In particular, the securingmember220 is sized and configured to slide into theelongate channels236,246 to securely clamp the tissue-engagingmembers205,210 around a body tissue or vessel with minimal compressive force. More specifically, the force required to secure and maintain the staple-clip (to provide adequate traction) is independent from the force required to constrict or occlude a body tissue or vessel. With the staple-clip of the invention, only the compressive force needed to perform a specific surgical procedure such as occlusion, ligation or fixation is applied to the body tissue, and the force normally required to secure and maintain a clip of the prior art is not applied since traction and security are supplied by the tissue-engagingmembers205,210. In other words, the staple-clip of the present invention provides the necessary traction without requiring an excessive compressive force to keep the staple-clip from moving or becoming loose. As a result, nourishment of the lightly compressed tissue is maintained and tissue necrosis due to over-compression is eliminated.
• In another aspect of the invention, the tissue-engaging members include traction enhancing features including bumps, ridges, slots, holes, etc. as generally illustrated in FIGS.13(a) and13(b). The traction enhancing features are sized and configured to grip tissue and provide traction and security beyond that which might be achieved by over-compressing a typical clip. The securingmember220 may be a spring-clip or a deformable clip acting as a retention member and providing a uniform pressure across the occluded tissue or vessel to prevent loosening of the staple-clip200 over time as illustrated in FIGS.7,9(a)-9(h) and14. The tissue-penetratingelements238,248 are configured to penetrate the tissue and to prevent the tissue from moving or sliding when clamped as illustrated in FIGS.11(a)-11(d),16 and17.
• It is appreciated that the connectingwalls234,244 and the respective tissue-penetratingelements238,248 may be formed as an integral, one-piece construction. It is further appreciated that the number of rows of tissue-penetrating elements and the number of tissue-penetrating elements per row may vary according to each application and the shape and size of the clip and body tissue. It is further noted that the tissue-penetrating elements in each row may be aligned or staggered as desired. The tissue-engagingmembers205,210 and the securingmember220 may have cross-sections of any configuration including polygonal, circular and elliptical configurations.
• Referring toFIG. 10, there is shown a monolithic staple-clip500 in accordance with another aspect of the invention. The monolithic staple-clip500 has a general shape of the capital letter “U”. The staple-clip500 comprises a first tissue-engaging portion orleg505, an opposed second tissue-engaging portion orleg510 and a deformable connectingportion520 connecting the first and second tissue-engagingportions505 and510. Each of the opposing faces of the tissue-engagingportions505,510 comprises a plurality of tissue penetrating elements orprotrusions525,530, respectively. The protrusions are sized and configured to penetrate tissue that is captured between the tissue-engaging portions and provide traction and security beyond that which might be achieved by over-compressing a typical clip. Similar to other aspects of the invention, only the force required to perform a specific surgical procedure such as occlusion, ligation or fixation is applied to a body tissue and the force previously needed to secure and maintain the clip is no longer applied. Nourishment of the lightly compressed tissue is thus maintained and tissue necrosis due to over-compression is eliminated.
• The monolithic staple-clip500 may be formed from a flat metal sheet that is die-cut, stamped or etched forming a first notched or toothed portion, a smooth connecting portion and a second notched or toothed portion. The notches or teeth of the first and second portions are then bent so as to extend in the same direction or plane and to form channels within the notches or teeth. The staple-clip is then formed in a U-shape by bending the connecting portion so that the notches or teeth of the two tissue-engaging portions are opposed. A preferred embodiment of the monolithic staple-clip comprises a malleable material such as Titanium or stainless steel. Other materials include any medically acceptable metal or plastic material that is ductile, malleable or deformable.
• It is appreciated that the staple-clips of the invention can be applied to a body tissue or vessel using anapplier600 as illustrated in FIGS.12(a)-12(d). The staple-clip applier600 generally comprises anelongate shaft605, sized and configured to fit through a surgical trocar port, adistal end610 having a pair ofopposed jaws615,620, and a proximal end (not shown) having a handle to open and close thejaws615,620. The staple-clip applier600 further comprises a slidingmember625 to advance the securingmember220 over the tissue-engagingmembers205,210 after closure of thejaws615,620 as further described below. Thejaws615,620 operate to apply the tissue-engagingmembers205,210, respectively, around a target body tissue or vessel. The tissue-engaging members are supplied to the jaws either manually or automatically. With the tissue-engagingmembers205,210 properly placed, thejaws615,620 can be compressed using only the force required for a specific surgical procedure such as occlusion, ligation or fixation. When the tissue-engagingmembers205,210 are properly applied, the slidingmember625 can then urge the securingmember220 forward and over the tissue-engagingmembers205,210 to secure the staple-clip200 as illustrated in FIGS.9(a)-9(h),11(a)-11(d) and14. The tissue-engagingmembers205,210 and securingmember220 may be introduced to a surgical site in an un-assembled condition through a small port or trocar.FIGS. 8 and 15(a)-15(c) further illustrate the staple-clip and applier sized and configured for use in a minimally invasive or laparoscopic surgical procedure.
• Multiple staple-clips may also be loaded in a staple-clip applier and advanced individually or simultaneously between the jaws. In the case of simultaneously applying the staple-clips, the applier must include a plurality of slots in the opposed jaws to receive the multiple staple-clips. A cutting member such as a blade may be included in the applier to be advanced between the staple-clips after they have been applied to transect the body tissue between the staple-clips as illustrated inFIGS. 17 and 18.
• In another aspect of the invention,FIG. 19 depicts a traditionallaparoscopic stapler800 that is configured specifically for donor nephrectomy. Thestapler800 includes a plurality of rows of staples on thepatient side805 and atemporary clip810 that substitutes for a typical set of staples on thekidney side815. Thestapler800 operates like existing place and cut staplers with the exception that a temporary clip or clips810 replace the set of staples on thekidney side815. Thetemporary clip810 may be a staple cartridge configured for use in donor nephrectomy. An advantage of this configuration is it salvages a greater portion of the vessel for the transplant procedure.
• Another aspect of the invention is directed to hand assisted laparoscopy (HAL), the widespread acceptance of which has created many opportunities for surgical advancement utilizing single hand procedures. FIGS.20(a)-20(e) illustrate thumb actuatedclip appliers850,875 and895 in accordance with the teachings of the invention. Theclip applier850 includes ahandle855 and a thumb actuatedmechanism860. An operator can slidably release clips865 onto a vessel by sliding the thumb actuatedmechanism860 forward870aand backward870busing only one hand as illustrated in FIGS.20(a)-20(b). This design closes the jaws around the vessel and allows a closed clip to slide into position. Thehandle855 also serves as a reservoir foradditional clips865. Theclip875 is also designed for HAL applications and includes afirst arm880 and asecond arm885 folded over thefirst arm880. Thefirst arm880 includes alatch mechanism890 such as an inwardly turned portion or hook at its distal end that is configured to interlock or mate with a distal end of thesecond arm885 when the arms are clamped together. Thelatch mechanism890 operates in a similar way to a hair clip and responds to thumb pressure. An operator may single-handedly access theclip875 and slide it onto a body tissue or vessel as needed.
• A plurality ofclips875 may be strung end-to-end in aclip sleeve892 suspended through an open port. An advantage of theclip875 is there is no instrument to misplace. Theclip sleeve892 holding theclips875 can also be withdrawn or fed through any open port or trocar. Theclip sleeve892 can also be designed to keep theclips875 partially closed, enabling the use of smaller ports or trocars. Theclip895 as illustrated inFIG. 20(e) is similar to theclip875 but further includes tissue-penetratingelements898 on the inner faces ofarms896,897. Theclip895 may also include athird arm899 connecting thearms896,897.
• In another aspect of the invention as illustrated inFIG. 21, a spring likecoil900 is used for suturing a body tissue or vessel in place of clips and staples. The spring likecoil900 is applied onto a body tissue orvessel905 by using astapler910 having groovedjaws910,915. The spring likecoil900 is preferably loaded or twisted into one of thegrooved jaws910,915, which is then compressed or clamped against the other grooved jaw to constrict or occlude thevessel905. An advantage of this design is closure of thecoil900 provides a stitch like nature that replicates a uniformly applied suture. In one configuration, a single coil is inserted in place of each suture. It is appreciated that a single coil or multiple coils may be loaded into the grooved jaws of a stapler for each specific surgical procedure or closure.
• In yet another aspect of the invention,FIG. 22 illustratesmultiple staples925 formed from a single piece ofmaterial930 to reduce the high manufacturing costs associated with current stapler cartridges. These costs savings translate to increased margins or reduced product cost. Each of thestaples925 has anangled leg935 and aninclined rail940 for easy push up and closure by a stapler. Thestaples925 all share acommon portion945, which allows the row of staples to be formed as an integral, one-piece construction. Thestaples925 can also be formed to offset each other and to emulate multiple rows. An advantage of this aspect of the invention is it provides a compact cartridge that is suitable for donor nephrectomy.
• FIG. 23 illustrates atemporary HAL clamp950 for use in donor nephrectomy in accordance with another aspect of the invention. Theclamp950 includes atubular section955 defining anopening960 extending from aproximal end965 to adistal end970, and a lead-inwire975 operably attached to theproximal end965. The lead-inwire975 is movable between an open position and a closed position. When closed, the lead-inwire975 is slidably received and secured in theopening960 of thetubular section955. During use, an operator may manually wrap a vessel or vessels (e.g., the renal artery and vein can be cinched together into the clamp) around the lead-inwire975 and secure thewire975 in theopening960 of thetubular section955. The lead-inwire975 may be bent against the wall of thetubular section955 to further secure the vessel(s) for kidney removal and transport.
• FIGS. 24, 25 and26 illustrate two-stage clips1010,1020 and1030, respectively, in accordance with additional embodiments of the invention. Theclips1010,1020 and1030 require an applier (not shown) for placement onto a body tissue or vessel. Theclip1010 includes aclip component1011 and astaple1012 for securing the clip after it has been properly positioned. Theclip component1011 is formed from a single wire and includes opposedarms1013,1014. Each of thearms1013,1014 includesopenings1015,1016, respectively, allowing penetration oflegs1017,1018 of thestaple1012. Thestaple1012 is formed from a second wire and is used to puncture the body tissue or vessel and interlock theclip component1011. Thearms1013,1014 may include a latch mechanism at the distal ends to mate with each other when the arms are closed or clamped together. During use, the first stage closes thearms1013,1014 of the clip. After the first stage, the clip can still be safely removed. The second stage secures the clip permanently onto the body tissue or vessel by applying the staple1012 to theclip component1011.
• The two-stage clip1020 as shown in FIG.,25 is formed entirely from a single piece of material and includes afirst arm1021 and an opposedsecond arm1022. Thesecond arm1022 further includes securingelements1023,1024, all of which are formed as an integral, one-piece construction. With this construction, the securingelements1023,1024 may still remain at an angle after the first stage (when thearms1021 and1022 are clamped upon a body tissue or vessel). A second action then presses the securingelements1023,1024 into the body tissue or vessel. Theclip1030 as shown inFIG. 26 is similar to theclip1010 and includes aclip component1031 and astaple component1032 for securing the clip after it has been properly positioned. Theclip component1031 includes opposedarms1013,1014 definingopenings1035,1036, respectively. Thestaple component1032 includes opposedarms1037,1038 having tissue-securingelements1039,1040, respectively, which operate to secure the clip onto a body tissue or vessel through theopenings1035,1036. Theclip1030 may be formed in sheet stock.
• FIG. 27 illustrates atissue holder1100 for use with staple-clips that may include sharp features, e.g., tissue-penetrating elements, that can potentially injure tissue during a surgical procedure. In particular, thetissue holder1100 is used to press a body tissue flat and to provide clearance during placement of a staple-clip.
• Although exemplary embodiments of the invention have been shown and described, many alterations and modifications may be made by those having ordinary skill in the art without departing from the spirit and scope of the invention. Therefore, it must be understood that the illustrated embodiments have been set forth only for the purposes of examples and that they should not be taken as limiting the invention. In addition, the words used in this specification to describe the invention and its various embodiments are to be understood not only in the sense of their commonly defined meanings, but to include any special definition given in this specification.

Claims (43)

1. A medical device to constrict or occlude a body tissue or vessel, comprising:

a first tissue-engaging member205 having opposed walls230,232 and a first connecting wall234 defining a first elongate channel236;

a second tissue-engaging member210 opposed to the first tissue-engaging member205 having opposed walls240,242 and a second connecting wall244 defining a second elongate channel246; and

a securing member220 for securing the first and the second tissue-engaging members205,210 such that front faces of the first and the second connecting walls234,244 are opposed to each other.

2. The medical device ofclaim 1, wherein each of the front faces of the first and the second connecting walls234,244 includes a plurality of tissue-penetrating elements238,248.

3. The medical device ofclaim 1, wherein the securing member220 is sized and configured to slide into the first and the second elongate channels236,246 to securely clamp the first and the second tissue-engaging members205,210 around the body tissue or vessel with minimal compressive force.

4. The medical device ofclaim 3, wherein the force required to secure and maintain adequate traction is independent from the force required to constrict or occlude the body tissue or vessel.

5. The medical device ofclaim 4, wherein only a compressive force needed to perform a specific surgical procedure such as occlusion, ligation or fixation is applied to the body tissue.

6. The medical device ofclaim 5, wherein tissue necrosis due to over-compression is eliminated.

7. The medical device ofclaim 1, wherein at least one of the first and the second tissue engaging-members205,210 includes a plurality of bumps, ridges, slots, and holes.

8. The medical device ofclaim 1, wherein the securing member220 is a spring clip or a deformable clip acting as a retention member and providing uniform pressure across the occluded tissue or vessel.

9. The medical device ofclaim 2, wherein the first and the second connecting walls234,244 and the tissue-penetrating elements238,248 are formed as an integral, one-piece construction.

10. The medical device ofclaim 2, wherein the tissue-penetrating elements238,248 are formed in a plurality of rows.

11. The medical device ofclaim 10, wherein the number of tissue-penetrating elements238,248 per row and the number of rows vary according to each application.

12. The medical device ofclaim 10, wherein the tissue-penetrating elements238,248 are aligned or staggered.

13. The medical device ofclaim 2, wherein the tissue-penetrating elements238,248 and the securing member220 have cross-sections of any configuration including polygonal, circular and elliptical configurations.

14. A medical device500 to constrict or occlude a body tissue or vessel, comprising:

a first tissue-engaging portion505 having a first face including a plurality of tissue penetrating elements or protrusions525;

a second tissue-engaging portion510 opposing the first tissue-engaging portion505 having a second face including a plurality of tissue penetrating elements or protrusions530; and

a deformable portion520 connecting the first and the second tissue-engaging portions505,510.

15. The medical device ofclaim 14, wherein only a force required to perform a specific surgical procedure such as occlusion, ligation or fixation is applied to the body tissue or vessel.

16. The medical device ofclaim 15, wherein tissue necrosis due to over-compression is eliminated.

17. The medical device ofclaim 14, wherein the medical device is formed from a flat metal sheet that is die-cut, stamped or etched forming a first notched or tooted portion of the first tissue-engaging portion505, a smooth connecting portion of the deformable portion520 and a second notched or toothed portion of the second tissue-engaging portion510.

18. The medical device ofclaim 17, wherein a plurality of notches or teeth of the first and the second portions are bent so as to extend in the same direction or plane and to form channels within the notches or teeth.

19. The medical device ofclaim 17, wherein the device is formed in a U-shape by bending the deformable portion520 so that the notches or teeth of the first and the second tissue-engaging portions505,510 are opposed.

20. The medical device ofclaim 14, wherein the device is formed from any medically acceptable metal or plastic material that is ductile, malleable or deformable.

21. The medical device ofclaim 20, wherein the metal includes titanium and stainless steel.

22. An applier600 for applying a medical device to constrict or occlude a body tissue or vessel, the device having a first tissue-engaging member205 having opposed walls230,232 and a first connecting wall234 defining a first elongate channel236, a second tissue-engaging member210 opposed to the first tissue-engaging member having opposed walls240,242 and a second connecting wall244 defining a second elongate channel246, and a securing member220 for securing the first and the second tissue-engaging members205,210 such that front faces of the first and the second connecting walls234,244 are opposed to each other, the applier comprising:

an elongate shaft605 having a proximal end and a distal end610;

a pair of opposed jaws615,620 connected at the distal end of the elongate shaft605;

a handle operably connected at the proximal end of the elongate shaft605 to open and close the opposed jaws615,620; and

a sliding member625 operably connected within the elongate shaft605 to advance the securing member220 over the first and the second tissue-engaging members205,210 after closure of the jaws615,620.

23. The applier ofclaim 22, wherein the jaws615,620 operate to apply the first and the second tissue-engaging members205,210 around a target body tissue or vessel.

24. The applier ofclaim 23, wherein the first and the second tissue-engaging members205,210 are applied to the jaws615,620 either manually or automatically.

25. The applier ofclaim 23, wherein the jaws615,620 are compressed using only a force required for a specific surgical procedure such as occlusion, ligation or fixation.

26. The applier ofclaim 25, wherein the first and the second tissue-engaging members205,210 and the securing member220 are introduced to a surgical site in an un-assembled condition through a small port or trocar.

27. The applier ofclaim 26, wherein the sliding member625 operates to urge the securing member220 forward and over the first and second tissue-engaging members205,210 to secure the medical device.

28. The applier ofclaim 27, wherein the applier and the medical device are sized and configured for use in a minimally invasive or laparoscopic surgical procedure.

29. The applier ofclaim 22, further comprising a plurality of slots in each of the opposed jaws615,620 to receive a plurality of the medical devices or multiple staple-clips to simultaneously apply the medical devices or staple-clips.

30. The applier ofclaim 29, further comprising a cutting member to be advanced between the medical devices or staple-clips after they have been applied to transect the body tissue or vessel between the medical devices or staple-clips.

31. A clip applier850 for applying a clip to constrict or occlude a body tissue or vessel, the clip having a first arm880 including a latch mechanism890 at a distal end and a second arm885 folded over the firm arm880 at a distal end and configured to interlock or mate with the latch mechanism890 of the first arm880, the applier comprising:

a handle885 for storing the clip; and

a thumb actuated mechanism860 operably slidable along the handle885 by sliding the thumb actuated mechanism860 forward870aand backward870bto release the clip.

32. The clip applier ofclaim 31, wherein the handle855 further comprises a reservoir for storing a plurality of clips865.

33. The clip applier ofclaim 32, wherein the plurality of clips865 are strung end-to-end in a clip sleeve892 suspended through an end port.

34. The clip applier ofclaim 33, wherein the plurality of clips865 are formed from a single piece of material.

35. A clip875 to constrict or occlude a body tissue or vessel, comprising:

a first arm880 including a latch mechanism890 at a distal end; and

a second arm885 folded over the firm arm880 at a distal end and configured to interlock or mate with the latch mechanism890 of the first arm880.

36. The clip ofclaim 35, wherein the latch mechanism890 is a hook.

37. The clip ofclaim 36, wherein at least one of the first and the second arms880,885 includes tissue-penetrating elements898 or securing elements1023,1024 on an inner face.

38. The clip ofclaim 35, further comprising a third arm899 connecting the first arm880 and the second arm885.

39. A clamp950 to constrict or occlude a body tissue or vessel, comprising:

a tubular section955 having an opening960 extending from a proximal end965 to a distal end970; and

a lead-in wire975 operably attached to the proximal end965 and is movable between an open position and a closed position,

wherein in the closed position, the lead-in wire975 is slidably received and secured in the opening960 of the tubular section955.

40. The clip ofclaim 39, wherein the lead-in wire975 is bent against a wall of the tubular section955 to further secure the body tissue or vessel.

41. The clip ofclaim 39, wherein the clamp is used in donor nephrectomy.

42. A medical device1010 to constrict or occlude a body tissue or vessel, comprising:

a clip1011 formed from a first wire including opposed arms1013,1014 and openings1015,1916; and

a staple1012 for securing the clip1011, the staple1012 formed from a second wire having legs1017,1018 to puncture the body tissue or vessel and to interlock the clip1011 through the openings1015,1016.

43. The medical device ofclaim 42, wherein the arms1013,1014 further comprise a latch mechanism at their distal ends to mate with each other when the arms1013,1014 are closed or clamped together.

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