US20130035699A1 - Dual insufflation and wound closure devices and methods - Google Patents

Abstract

A dual functioning instrument set, comprising a needle and guide, has not only the capabilities to enter and insufflate the abdominal cavity but also the ability of a suture passer to carry and retrieve suture for closure of the incision sites at the end of the procedure. The needle contains a deployable snare that is used to pass and retrieve suture. The guide is used to repeatedly locate the needle relative to the inner abdominal wall allowing for consistent placement of sutures. For insufflation purposes, obturator tips having different distal structures are provided for shielding the sharp needle tip after insertion through a body wall.

Description

RELATED APPLICATIONS
• This application relates to, claims priority from, and incorporates herein by reference, as if fully set forth, U.S. Provisional Patent Application Ser. No. 61/574,455 filed on Aug. 4, 2011 and entitled “INSUFFLATION/CLOSURE DEVICE AND GUIDE.”
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• This invention relates to surgical instruments for approximation, ligation and fixation of tissue using a suture, and particularly to the approximation of tissue separated by means of an endosurgical trocar being inserted into a body cavity. This invention also relates to the access to an anatomic cavity or space during a medical procedure, and particularly to insufflations of the abdominal cavity for laparoscopic surgery.
• 2. Description of Prior Art and Related Information
• Numerous methods currently exist for performing laparoscopic procedures. One of the more commonly used methods is known as closed laparoscopy which utilizes a sharp needle (eg. Veress needle) to puncture the abdominal wall and insufflate the abdominal cavity with an inert gas such as carbon dioxide through the needle. This process of insufflating the cavity separates the abdominal wall from the underlying organs creating a gap for the surgeon to work within. A trocar/cannula system is then used to maintain the insufflated cavity and provide a working portal for which instruments can be passed into and out of the abdominal cavity to perform various surgical procedures. When the procedure is completed, it is desirable for the surgeon to close the incision site using suture material to minimize the risk of adverse post-operative events.
• Insertion of the needle into the abdomen is performed without any visual aid to facilitate location of the sharp needlepoint. In order to reduce the probability of inadvertent penetration of delicate internal organs in this “blind” procedure, the sharp insufflation needle contains a rounded member disposed within the lumen of the needle, and biased by a spring to an extended position beyond the needle tip.
• The conventional insufflation needle also includes a means for introducing an inert gas into the abdominal cavity through a channel or opening within the lumen of the needle. A luer or other quick connect type adapter is typically housed within the proximal handle of the needle to connect a gas source to the needle. The gas then travels from the handle through the length of the needle and exits into the body cavity from the distal tip of the needle.
• One of the post-operative complications associated with this procedure is the incidence of trocar site hernias, where a portion of an organ or fatty tissue protrudes out through the hole in the abdominal wall created by the trocar access portal. It is believed that improper closure, or complete lack of closure, of the incision site at the peritoneum is the primary cause of these hernias which form during the post-operative period ranging from several days to several months following the procedure. Traditional methods of wound site close require an additional set of instruments (suture passers, guides, etc.) to be introduced into the surgery. A number of these instruments have been previously disclosed. However, the prior art related to trocar wound site closure instrumentation are typically cumbersome to use and do not provide for a simple, reproducible, and reliable means of closing the wound site.
• In order to safely perform a closed laparoscopic procedure, both a Veress needle and a suture passing device may be purchased and used for the completion of the procedure. This can be both expensive and create additional waste, unnecessarily. The present invention comprises a combination device that can provides the multiple functions that were not previously offered in the prior art.
BRIEF SUMMARY OF THE INVENTION
• In accordance with the present invention, structures and associated methods are disclosed which address these needs and overcome the deficiencies of the prior art. A preferred system according to the invention comprises a surgical instrument as well as a surgical instrument set that may have one or two basic functions.
• First, the system may have the capabilities to provide entry into the abdominal cavity and subsequently insufflating the cavity for use in laparoscopic surgical procedures. In the preferred embodiment, the system comprises a needle apparatus having a sharp needle tip and an insufflation channel to facilitate penetration into the abdominal cavity and insufflation. A unique obturator tip is provided to shield the sharp needle tip upon insertion into the cavity.
• Second, the system may have the capabilities to close the fascial/peritoneal layer at the trocar wound site in a quick, consistent and reproducible manner at the end of the procedure. To facilitate closure of the wound, the system includes a guide used in combination with the same needle apparatus which also serves as a suture engaging device. In the preferred embodiment, the system would have both of the capabilities described above.
• The needle apparatus may be able to function like a suture passer, in that it has the ability to carry and retrieve suture through tissue layers for suturing closed the wound site. The needle also has the ability to insufflate the abdomen during the laparoscopic procedure. The needle apparatus may comprise several components including: a handle, actuation mechanisms, means for connecting the needle to a gas line, a deployable snare, a needle tip, a hollow inner shaft inside the needle tip, and a safety mechanism plunger disposed within the needle tip.
• In a preferred embodiment, a handle at the proximal end of the needle apparatus allows for single-handed or double-handed use. An actuator mechanism is disposed adjacent to the handle and configured for the deployment and retraction of the snare used to pass and retrieve the suture material. The preferred actuator mechanism may include a first actuator comprising sliding trigger that translates along the long axis of the handle that locks the snare against the needle when it is in one position, and partially deploys the snare loop when the trigger is set into a second position. This trigger may be spring loaded to ease the deployment of the snare from within the needle. A second actuator may comprise a sliding plunger, or extender rod, that exits from the proximal end of the handle and translates along the long axis of the handle. This extender rod would be used to fully deploy the snare. The handle and actuator means may be constructed from metals (such as stainless steel, titanium, or aluminum) or plastics (such as polyacetal, nylon, PEEK, or polycarbontae), or any combination of the two.
• The snare accomplishes the suture passing capabilities of the needle apparatus. As previously stated, the snare may be actuated between three different positions: (1) completely retracted into the needle shaft, (2) partially deployed, and (3) fully deployed. When the snare is completely retracted into the needle shaft, the suture material would be captured between the snare and the inner shaft of the needle apparatus. When the snare is partially deployed, a small loop section of the snare would be exposed. This partial deployment of the snare may allow for certain simple suture passing steps to be accomplished without having to fully deploy the snare. When the snare is fully deployed, a larger loop section of the snare would be exposed that is significantly greater in size than the partially deployed loop. The fully deployed snare would be most useful when trying to retrieve the free end of the suture within the body cavity by providing a large target in which the suture can be grasped. Optimally, the snare would be deployed perpendicular to the long axis of the needle to simplify the suture passing process, however the snare may be deployed over a broader range of angles from the needle ranging from 0-180 degrees relative to the long axis of the needle. The snare would most optimally be manufactured from a shape memory alloy material such as Nitinol, but may also be made from other metallic or polymeric wire materials.
• A long outer needle shaft may be connected to the proximal handle and extends distally over a length that may range from 1-15 inches. The outer needle shaft may have a sharp tip, or needle peak, at the distal-most point to ease the insertion of the needle through the various tissue layers. The outer shaft may house an inner shaft that has a hollow, unobstructed inner lumen. This unobstructed inner lumen may allow for the passage of an inert gas for insufflation of the abdomen. A luer connector or other quick connect type device may be disposed on the proximal handle to provide an entry passageway for the gas to enter into the needle. The unobstructed inner lumen may also provide a passageway for the snare material to travel up through the needle portion and into the handle so that it can be connected to the actuator mechanism.
• The distal-most end of the inner shaft may have a blunt obturator attached to the tip. The entire inner shaft may be spring loaded to allow for the blunt obturator to translate away from the tip of the needle when it is loaded, and passively travel back to the tip of the needle when it is unloaded. The obturator spring may be housed within the handle. The spring loaded obturator would serve as a safety mechanism for protecting the internal organs within the abdomen. The inner and outer needle shafts would optimally be constructed from metallic tubes such as stainless steel. The obturator tip may be manufactured from a number of different materials including, but not limited to, metals and plastics.
• In another preferred embodiment, the needle apparatus may have a single actuator to control the snare between a fully exposed position and a fully retracted position. The single actuator may comprise a lockout trigger similar to the first preferred embodiment, except that the lockout trigger can proximally translate with respect to the housing a greater distance so as to proximally push the slide rod connected to snare all the way to fully expose the snare.
• The guide apparatus may be used to guide the needle through the abdominal wall in a repeatable manner. The guide may comprise an outer housing, or barrel, and an inner plunger used to actuate the guide.
• The barrel may have two or more counterforce tabs, or extension tabs, at the proximal end to aid in the handling and insertion of the guide into the abdomen. These counterforce tabs may provide surfaces for the user to utilize two fingers to hold the barrel. For example, the index finger would be placed under one tab, and the middle finger is placed under the second tab. The thumb may then be used to actuate the proximal surface of the plunger and secure the guide within the user's grasp.
• The distal end of the barrel would have a blunt tip to minimize the potential of harm or damage to the adjacent tissue during insertion. Just proximal to the blunt tip the barrel may have a deformable securing mechanism that may have two configurations. The first configuration of the deformable section would be aligned with the wall of the outer housing such that the structure has a slender, continuous outer diameter. This first slender position would be utilized during the insertion of the guide into the cavity. The deformable section can then be deformed to a second flared out position where securing mechanism extends beyond the outer diameter of the outer housing. The securing mechanism, comprising expanding feet in the preferred embodiment, is used to place the guide against the inner wall of the abdomen to provide a reference point for the needle to be repeatedly placed in the same location of the abdominal wall that is required to be sutured for closure of the portal site.
• Along the central portion of the shaft of the barrel are multiple slots in the shaft wall. These slots serve to provide a passageway for the needle apparatus to travel to the appropriate location of the abdominal wall for the placement of sutures. Two slots may be placed opposing each other near the proximal end of the shaft, and two additional slots may be placed opposing each other near the distal end of the shaft. The proximal slots may serve as the entry points for the needle, while the distal slots may serve as the exit points for the needle. The guide also includes axial wings, which may be extruded, extending away from the central axis of the shaft to aid in pushing away fatty tissue that is undesirable tissue for the suture to pass through. Particularly if these features are located near the distal slots where the needle is exiting the guide, the risk of suturing unwanted fatty tissue is minimized.
• The guide may comprise a plunger slidably disposed within the barrel. The plunger may be used to actuate the expanding feet, comprising living hinges in the preferred embodiment, on the barrel. This plunger may be spring loaded such that the plunger is biased to the radially expanded position. When the plunger is in the biased flared out position, the feet would be in the expanded position. When the plunger is pressed to the first position, the feet would be retracted back to a position that aligns the outer diameter of the outer housing in a continuous slender fashion. The plunger may be attached to the distal end of the barrel. Along the shaft of the plunger would be through holes that align with the outer housing slots to accommodate passage of the needle apparatus through the guide. These through holes may intersect each other, or may be offset such that the holes do not intersect one another. All of the guide components would preferably be made from an injection moldable polymer (such as polycarbonate, polyacetal, nylon, or ABS) but the guide may be machined from other plastics and/or metals.
• The basic procedural steps for abdominal entry and insufflation of the cavity may flow as follows. The needle is used to enter the abdominal cavity using standard closed laparoscopic techniques. A gas line is connected to the handle allow for an inert gas to be passed into the abdominal cavity. The inert gas is then turned on until the cavity reaches an appropriate level of insufflation to allow for the procedure to be performed with appropriate visualization. The needle is then removed, and a trocar is inserted into the puncture site to perform the procedure.
• The basic procedural steps of the utilization of the suturing system may flow as follows. At the end of the surgical procedure, the trocar is removed and the needle guide is placed into the wound. The expandable feet are deployed against the inner wall of the peritoneum. A short end of a suture tail is captured within the snare, while outside the body cavity. Then the needle apparatus is advanced through the needle guide and tissue layers into the abdominal cavity, carrying the suture with it. The snare is expanded to release the suture. The needle apparatus is then removed from the guide and reinserted through the opposite side of the guide on the opposite side of the puncture wound. When the distal end of the assembly is exposed in the abdominal cavity, the snare is expanded to provide an easy target to secure the existing suture tail inside the abdominal cavity. Once the suture has been secured within the wire snare, the needle apparatus is removed to outside the body cavity, bringing the suture along with it. The suture is then released from the snare wire. The suture is in place to be tied with a knot to provide closure the trocar puncture site. This suturing procedure may also be accomplished without the use of the needle guide.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIGS. 1A-1B show a preferred embodiment of a needle guide in an actuated position with a securing mechanism not expanded;
• FIGS. 1C-1D show the preferred needle guide in the resting position with the securing mechanism expanded;
• FIG. 2 is a cross sectional view of the preferred needle guide showing the needle tracks;
• FIG. 3 shows the guide as it is placed through a section of tissue with the expanded feet resting against the inner peritoneal wall;
• FIG. 4A shows an oblique view of the needle with the snare fully retracted into the needle;
• FIG. 4B shows an oblique view of the needle with the snare partially extended;
• FIG. 4C shows an oblique view of the needle with the snare fully extended;
• FIG. 5A is a cross-sectional view of the needle housing showing the internal components of the needle corresponding to the fully retracted snare position inFIG. 4A;
• FIG. 5B is a cross-sectional view of the needle corresponding to the partially extended snare position shown inFIG. 4B;
• FIG. 5C is a cross-sectional view of the needle corresponding to the fully extended snare position shown inFIG. 4C;
• FIG. 6A is a detail view of the distal tip of the needle with the spring loaded safety obturator;
• FIG. 6B is a cross-sectional view of the distal tip of the needle;
• FIG. 6C is a close-up perspective of the housing of the needle apparatus showing a preferred lockout trigger;
• FIG. 7A is an oblique view of a standard retractable obturator tip design;
• FIG. 7B demonstrates the relative distance from the tip of the needle to the tip of the obturator;
• FIG. 7C is an oblique view of an alternative retractable obturator tip design;
• FIG. 7D demonstrates the relative distance from the tip of the needle to the tip of the alternative obturator;
• FIGS. 8A-C show various alternative embodiments of the handle portion of the needle;
• FIG. 9 shows the suture being loaded into the snare;
• FIG. 10 shows the needle passing suture through the guide and tissue;
• FIG. 11 shows the needle being used to retrieve the free end of the suture;
• FIG. 12 illustrates a preferred method for insufflating a body cavity and engaging a suture to close a wound using a single device; and
• FIG. 13 illustrates a preferred method for closing a surgical wound using a system comprising preferred embodiments of a guide and a suture engaging device disclosed above.
• FIG. 14 is a perspective view of a second preferred embodiment of a needle apparatus comprising a single actuator mechanism with the snare in the fully exposed position;
• FIG. 15 is a perspective view of the second preferred needle apparatus showing the snare in the fully retracted position.
• The various embodiments of the invention can now be better understood by turning to the following detailed description wherein illustrated embodiments are described. It is to be expressly understood that the illustrated embodiments are set forth as examples and not by way of limitations on the invention as ultimately defined in the claims.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS AND BEST MODE OF INVENTION
• In a preferred embodiment, a system100 is provided for insufflating an abdominal cavity and closing a trocar wound site. The system100 comprises a guide and a single device having dual functionalities of insufflation and suture engagement.
• FIGS. 1A-1D illustrate a preferred embodiment of a surgical guide apparatus, or simply guide,10 for directing surgical instruments through a body wall. Theguide10 may be particularly useful for directing suturing devices used in closing wounds, or openings through body walls, made in surgical procedures to access internal body cavities. Theguide10 comprises a radiallyexpandable securing mechanism26 at adistal end16 that is configured to secure theguide10 to the inner wall of a body cavity, such as the peritoneum surrounding an abdominal cavity in the case of a laparoscopic procedure.
• InFIG. 1A, aplunger21 is slidably disposed within abarrel23 having a barrelproximal portion15 and a barrel distal portion17. Theplunger21 andbarrel23 may be connected to each other bydeformable locking tabs29 at a distal end12 of theplunger21, that lock within the bluntdistal end cap30 of thebarrel23. At a proximal end14 of theplunger21 is anactuation surface22 that may be flat or contoured that allows for the plunger to be pressed down to slide theplunger21 within thebarrel23.
• As theplunger21 translates with respect to thebarrel23, the radiallyexpandable securing mechanism26 at thedistal end16 of thebarrel23 moves between two positions of radially expanded, or flared out, as shown inFIGS. 1C and 1D, and radially contracted, or slender, as seen inFIGS. 1A and 1B. In the preferred embodiment, the internalcavity securing mechanism26 comprises two or more expandingfeet26 radially spaced apart from each other. The expandingfeet26 each preferably comprise a living hinge section composed of the same material as thebarrel23, where the material is cut thin at specific locations allowing for the material to flex. It is to be expressly understood that the radiallyexpandable securing mechanism26 may comprise a variety of structures capable of moving between slender and flared-out configurations. Radially adjacent to the expandingfeet26 may be one or more distally extendingstop tabs31 on the barrel, as shown inFIGS. 1A and 1B. Thestop tabs31 are configured to provide a mechanical stop for thedistal end cap30 of thebarrel23 to collide against to prevent theplunger21 from over-translating and potentially damaging the thin section of material within the expandingfeet26.
• InFIGS. 1B and 1D, wwo counterforce tabs, or extension tabs,24 are preferably disposed near a proximal end18 of thebarrel23 and configured to be grasped with one or more fingers while the thumb may be used to press down on theactuation surface22. Thecounterforce tabs24 facilitate ease of handling of theguide10. Theguide10 comprises at least oneneedle entry slot27 in the barrelproximal portion15 preferably distal to thecounterforce tabs24.
• In the preferred embodiment, theguide10 provides two different, diagonal pathways for a needle apparatus and thus comprises first and second entry slots27a,27bas more clearly shown inFIG. 2. These barrel entry slots27a,27bprovide for entry points for a suture engaging device, or needle apparatus, to enter theguide10. The two barrel entry slots27a,27bare preferably axial in that they27a,27bextend over a length that is parallel to a long axis “A” of theguide10. The barrel entry slots27a,27bare preferably equally spaced apart in a radial manner from each other, i.e., 180 degrees apart if there are two slots, 120 degrees apart if there are three slots, etc. Theguide10 comprises barrel exit slots28a,28bequal in number to the entry slots27a,27band located distally along thebarrel23.
• Theguide10 is useful for directing suture engaging devices, and particularly a preferred embodiment of a suture engaging device discussed further below and identified simply as a needle apparatus. Accordingly, theguide10 preferably comprises two pathways diagonal to each other and oriented to direct a needle apparatus to both a first internal location to carry and release a suture, and a second internal location preferably horizontally opposite to the first internal location in order to facilitate retrieval of the suture using the preferred suture engaging device discussed further below.
• FIG. 2 is a cross sectional view of theguide10 showing the preferred dual pathways that a surgical instrument, such as a needle apparatus or suture engaging device, can take through theguide10. Theguide10 preferably comprises first and second plunger entry points33a,33badjacent to the plunger proximal end14 and first and second plunger exit points34a,34badjacent to the plungerdistal end16. A first tunnel, or first track,35adefines a first track axis “A1” and is in communication with both the first plunger entry33aformed on a first side of theplunger21 and the first plunger exit34awhich is preferably formed on an opposing side of theplunger21. The first entry33a, first tunnel35aand first exit34acollectively form a first needle pathway that is preferably oblique to the guide axis “A.”
• A second tunnel, or second track,35bis in communication with both the second plunger entry33bformed on the second side of theplunger21 and the second plunger exit34nwhich is preferably formed on the opposing first side of theplunger21. Thus, the first and second tunnels35a,35bare preferably off-axis and diagonal to each other. These tunnels35a,35bmay intersect each other as shown, or have their paths offset such that they do no intersect. The second entry33b, second tunnel35band second exit34bcollectively form a second needle pathway oblique to the guide axis “A” and diagonal to the first pathway. Theplunger21 on theguide10 may be passively controlled by a spring32 that is housed between theplunger21 andbarrel23 to keep the guide in the biased open position with thefeet26 expanded. It will be appreciated that biasing theguide10 to this hands-free operative configuration with thefeet26 expanded and the pathways open frees up both of the surgeon's hands to work with other instruments when theguide10 is inserted into the trocar wound.
• The barrelneedle exit slots28 may be surrounded by up to two opposingtissue distraction wings25. Thesewings25 help separate unwanted tissue away from theneedle exit slots28.
• In the case of a laparoscopic surgery involving use of a trocar, theguide10 may be placed through the tissue layers of the open trocar wound site as shown inFIG. 3 after the trocar has been removed. This tissue may consist of theskin36,adipose tissue37, muscle andfascia38 andperitoneal layer39. Prior to insertion of theguide10, thefeet26 are in the slender, non-expanded position with theplunger21 pressed. Once the distal end12 of theguide10 is appropriately placed under the peritoneal layer, theplunger21 is released and spring-biased to the operative configuration causing the living hinges26 to expand as shown inFIG. 3. With the radiallyexpandable securing mechanism26 in the flared out configuration, theguide10 can then be pulled up against the inner peritoneum to align the needle tunnels35a,35bwith the appropriate tissue layers for suturing. The plunger entry holes33 for the needle apparatus are positioned above theouter skin layer36, while the plunger exit holes34 for the needle apparatus should be positioned just above the muscle andfascia layer38 to be sutured. Thetissue distraction wings25 aid in pushing away unwanted adipose37 or fatty tissue from the needle exit holes34 such that primarily muscle andfascia tissue38 is sutured.
• FIGS. 4A-4C illustrate a preferred embodiment of a dual insufflation and wound closure device, or simply needle apparatus,49 which may be used in connection with the preferred guide discussed above. Theneedle apparatus49 serves the dual purposes of insufflating an abdominal cavity as well as engaging and passing suture to close a wound. Theneedle apparatus49 includes a puncture closure mechanism, or suture engaging mechanism, preferably comprising adeformable snare57 movable between three functional positions as depicted inFIGS. 4A-4C. Thesuture snare57 may be fully retracted within a needle shaft assembly, or simply needle shaft,55 (FIG. 4A), partially extended (FIG. 4B) to a temporary fixed position, or fully extended (FIG. 4C). Thesnare57 may comprise a single wire or, preferably, a plurality of interwoven strands to reduce strain and allow for a greater angle of flexure. The snare may also include in curvature in shape to reduce stain and prevent the snare from experiencing permanent deformation. In the preferred embodiment, thedeformable snare57 is composed of a shape memory alloy material such as Nitinol, but may also be made from other metallic or polymeric wire materials.
• In the preferred embodiment, a rod assembly, or slide rod,53 is coupled to thesnare57. Therod assembly53 comprises a rod distal portion53-1 connected to thesnare57 and disposed within theshaft assembly55 and a rod proximal portion53-2 protruding out from the housingproximal portion46. In the preferred embodiment, the rod distal portion53-1 is integral with the rod proximal portion53-2, although the two rod portions53-1,53-2 may comprise separate pieces axially coupled to each other.
• In the preferred embodiment, adual actuator mechanism45 disposed adjacent to a proximal end of theneedle housing50 controls the position and configuration of thesnare57. Thedual actuator mechanism45 preferably comprises afirst actuator53 configured to move thesnare57 between the fully exposed position and the fixed partially exposed position, and asecond actuator52 configured to move thesnare57 between the fixed partially exposed position and a fully retracted position. Theneedle housing50 comprises a housingproximal portion46 and a housingdistal portion47.
• Thefirst actuator53 preferably comprises a slide rod, or extender rod,53, axially protruding out from the housingproximal portion46. Aknob54 may be coupled to the proximal end of the rod proximal portion53-2 to facilitate use of thefirst actuator53. In the preferred embodiment, theslide rod53 is slidably disposed within theneedle housing50, and coupled to thesnare57 that travels through theneedle housing50 andneedle shaft55 to the distal tip of theneedle56. When theslide rod53 is fully pushed into theneedle housing50 in a distal direction, thesnare57 is fully extended (as inFIG. 4C).
• Since thedeformable snare57 is composed of a material having shape memory characteristics, thesnare57 is preconfigured to form a loop that is substantially perpendicular to the shaft axis A when fully exposed. In this fully exposed configuration as shown close-up inFIG. 11, thesnare57 forms an elongate loop having adistal loop tip61 connected to a pair ofdistal loop sections62, which are preferably linear, which are connected to archedmajority loop sections63. As thesnare57 is moved from the partially exposed position to the fully exposed position, thesnare57 forms a loop that not only increases in size, but also curves back towards theshaft55 to form a perpendicular orientation with respect to the shaft axis “A.” Thus, thesnare57 travels an arcuate path bent towards theshaft55 as thesnare57 moves from the partially deployed to the fully deployed configuration.
• When theslide rod53 is proximally pulled toward an extended, protruding position as shown inFIG. 4B, the deformable loop decreases in size as thesnare57 is retracted into the needledistal tip56. When pulled in the proximal direction, theslide rod53 will continue to retract thesnare57 until thedistal loop tip61 contacts the exit ramp of the obturator. Thefirst actuator53 is partially spring loaded in a manner that only when theslide rod53 nears the fully extended proximal position, theslide rod53 engages thefirst spring mechanism64 which biases theslide rod53 distally to a rest position. This spring-biased rest position corresponds to the fixed partially exposed position of thesnare57, shown inFIGS. 4B and 9. It will be appreciated that the partially exposed position as shown inFIG. 4B is fixed in the sense that further retraction of thesnare57 beyond this point requires actuation of the second actuator, which in the preferred embodiment comprises proximal movement of thethumb slide52 as discussed further below.
• This partial spring loading of theslide rod53 allows for thesnare57 to rest in the fixed partially exposed without actuation. In this fixed partially exposed configuration, thesnare57 protrudes sideways from theneedle shaft55 and forms a substantially planar loop where the twolinear loop sections62 are substantially parallel to each other as shown inFIG. 6A. This planar loop is off-axis with respect to the shaft axis “A.” Thus, in either the partially exposed or fully exposed position, the deformable loop is slanted with respect to the axis “A” of theshaft assembly55. Since thesnare57 is substantially planar in this fixed, partially exposed position, theloop snare57 travels linearly as it is further retracted into a fully hidden, retracted position.
• Thesecond actuator52, which comprises a lockout trigger or thumb slide in the preferred embodiment, controls movement of thesnare57 from the fixed partially exposed configuration to the fully retracted position, and locks thesnare57 in the fully retracted configuration. When theslide rod53 is proximally extended to the spring biased rest position, a mating mechanism is provided between theslide rod53 and thetrigger52 such that proximal actuation of thetrigger52 moves theslide rod53 proximally which further retracts thesnare57. In the preferred embodiment, the mating mechanism comprises anotch66 formed in theslide rod53 which is configured to mate with an inwardly protrudingfin67 of thetrigger52.
• When theslide rod53 is in the spring-biased rest position, thenotch66 is aligned with thefin67 such that proximal movement of thetrigger52 engages theslide rod53 and pulls theslide rod53 out to its most extended proximal position which fully retracts thesnare57. Thelockout trigger52 is then locked to theneedle housing50 by mating features between the two. In the preferred embodiment, a tongue68 on thetrigger52 mates with agroove69 formed in the sidewall of thehousing50. To unlock thetrigger52, thedistal end71 of thetrigger52 can be slightly lifted away from theneedle housing50 to release the tongue68 from thegroove69. Asecond spring mechanism73 biases thetrigger52 distally and moves theunlocked trigger52 to its proximal most position, at which point thetrigger52 is released from theslide rod53. When thetrigger52 is unlocked from thehousing50 disengaged by the user, the first andsecond spring mechanisms64,72 distally urge the first andsecond actuators53,52, respectively, thereby returning the extender to the rest position allowing for partial exposure of the wire snare57 (as inFIG. 4B).
• In the preferred embodiment shown inFIG. 6 C, thelockout trigger52 is disposed on anouter surface73 of thecylindrical housing sidewall74 opposite to the exit of the snare and constrained byside tracks75 and atop slot76. Other features on the housingouter wall74 may be employed to constrain thetrigger52. As thetrigger52 is pushed distally by thesecond spring mechanism72, thetrigger52 rides along the ramped tracks75 and through thetop slot76 formed in thehousing sidewall74 which separate theslide52 from therod53 and facilitates disengagement thereof.
• Referring back toFIG. 4A, theneedle housing50 may also have a quick connect mechanism, such as a luer connection51 somewhere along its length. The luer connector51 allows for an inert gas line to be connected to theneedle apparatus49. As the gas enters theneedle apparatus49, it flows distally through the hollow insufflation lumen, or insufflation channel,41 of theneedle shaft55 and exits theneedle apparatus49 at the distal tip. This allows for insufflation of the abdominal cavity.FIG. 5A is a detailed view of theneedle apparatus49 showing a first preferred embodiment of a blunt obturator assembly77 of particular use when theneedle apparatus49 is used as an insufflation device.
• InFIG. 6A, the obturator assembly77 comprises a first preferredblunt obturator tip78 having a generally flat top79 at a distal end. Theneedle shaft55 has asharp needle tip82 at a distal end preferably comprising a needle peak83 and a pair of blade edges84 extending proximally and laterally therefrom, as shown inFIGS. 7A-7D. Theneedle tip82 facilitates insertion of theneedle shaft55 through the tissue layers. In order to prevent damage to the underlying organs, the spring loadedblunt obturator tip78 is slidably disposed within theneedle shaft55. Theblunt obturator tip78 is connected to anobturator shaft86 by adowel pin87. A window cutout88 in theobturator shaft86 provides a location for thesnare57 to exit theneedle apparatus49. Theblunt obturator tip78 partially extends up the length of theobturator shaft86. An exit section90 adjacent to the window cutout88 has two tracks, or exit slots,92 to accommodate the passage of thesnare57. The preferably twodistinct tracks92 prevent thesnare57 from being pulled all the way up theneedle shaft55, or becoming twisted as it is retracted and extended from theshaft55.
• FIG. 6B shows a cross-sectional view of the distal tip of the needle instrument. One of the needle tracks92 is shown to guide thewire snare57 distally out the window cutout88 in theobturator shaft86. The needle tracks92 also guide thesnare57 proximally into the push rod93 that extends proximally.
• In the preferred embodiment, theshaft assembly55 comprises an inner snare push rod93 disposed within theobturator shaft86, which is disposed with anouter shaft43 that forms the distal needle tip. Theinner obturator shaft86 defines the insufflation lumen41.
• Referring back toFIG. 5A, the internal workings of theneedle apparatus49 are shown inFIG. 6. Theneedle shaft43 is connected to thedistal end58 of theneedle housing50 via aneedle hub94. Theobturator shaft86 which is slidably disposed within theneedle shaft55, connects to aobturator hub95 that is proximal to theneedle hub94. Theobturator hub95 is slidably disposed within theneedle housing50 and spring loaded by aspring96 that allows theobturator shaft86 to translate as theobturator tip78 is pressed against.
• The snare push rod93 is slidably disposed within theneedle housing50 and theobturator shaft86 and fixed to theslide rod53. Thesnare57 is fixed to the proximal end59 of theslide rod53 and travels through theslide rod53, through thesnare push rod86, and ultimately out through the obturator tip78 (as shown inFIG. 5). Since thesnare57 is flexible, it requires passage through rigid structures so that it can extend and retract at the needle tip.
• At the proximal end of theslide rod53 is aslide rod pin65 that may serve multiple purposes. Thepin65 helps to maintain the rotational alignment of theslide rod53 within needle housing. Thepin65 also engages the first spring mechanism, or the slide rod spring,64 when thesnare57 approaches retraction back into the needle, partially spring loading the travel of theslide rod53 distally back to the rest position.
• As discussed above, thetrigger52 is also spring loaded by a second spring mechanism, or trigger spring,72, causing thetrigger52 to be biased in the distal direction. As thetrigger52 is pulled proximally, it engages with theslide rod53, and pulls it back against the force of theslide rod spring64. Thelockout trigger52 can then be locked to theneedle housing50, locking out thesnare57 in the fully retracted position. Both thetrigger spring72 andslide rod spring64 are constrained to theneedle housing50 by proximal plugs98 that may be pinned to theneedle housing50.
• FIGS. 7A and 7B provide close-up view of the obturator assembly77 with theflattop obturator tip78. Theflattop obturator tip78 has aflat front95 withrounded corners102.
• FIGS. 7C and 7D show a secondpreferred obturator assembly110 having a unique rampedobturator tip112. The rampedtip obturator tip112 comprises anobturator peak114 with a smaller cross sectional area “C”, allowing for more exposure of the sharpened blade edges84 of theouter needle shaft55. In the preferred embodiment, the rampedsurfaces116 are positioned proximally to the blade edges84 when theobturator peak114 distally traverses the needle peak83 up to5 mm. Theobturator peak114 defines a surface area preferably less than0.1 square mm. In the preferred embodiment, the surface area of theobturator peak114 is0.06 square mm or less. Moving proximally away from the distal obturator peak91, the cross-sectional area of atapered section116 increases in area, until the area at thebase118 of the taperedsection116 is equivalent to thedistal end121 of theobturator tube123.FIG. 7B shows the distance “D1” the flattop distal tip85 needs to be from the needle peak83 to expose the sharp needle edges84.FIG. 7D shows this a shortened distance “D2” with the rampedobturator tip design110 between the needle peak83 and theobturator peak114. This preferredramp obturator tip110 allows the spring loaded obturator mechanism to advance in a quicker manner through the tissue layer and thus provide enhanced safety by reducing the exposure time of the sharp needle peak83. Thepreferred ramp obturator110 may also facilitate the ease of insertion of the needle through the tissue layers.
• Alternative ergonomic handle designs are proposed inFIGS. 8A-8C. InFIG. 8A a simplified alternative handle design is shown, compared to the primary embodiment disclosed above. Ahandle130 is shown with twoextension tabs134 that can be supported in the hand by two fingers (such as the index and middle finger). Theplunger136 has a surface138 that can be pressed by another finger (such as the thumb) in order to advance theplunger136 and deploy the snare. Theplunger136 may be spring loaded with respect to thehandle130, so that theplunger136 is biased in the direction that retracts the snare.
• InFIG. 8B, an alternative preferred embodiment of ahandle140 comprises twofinger slots142 each configured to receive a finger, and ahole144 formed on the plunger146 for receiving a thumb. As the thumb slides distally, the plunger148 also advances distally inside thehandle140, deploying the snare.
• InFIG. 8C, a further preferred embodiment of ahandle150 comprises an inverted design with respect to the embodiment shown inFIG. 8B. Here, two fingers (such as the index and middle fingers) can be placed inside thefinger slots152 on theplunger154, while another finger (such as the thumb) can be placed in thehole156 of thehandle150. In this embodiment, the two fingers in theplunger154 would be advanced distally to deploy the snare.
• The following describes a preferred method of wound closure or suture passing using the first preferred embodiment of the wound closure system described above in connection withFIGS. 1-6. Theguide plunger21 is translated, preferably pressed down, to contract thefeet26, and causing theguide10 to take a slender, continuous profile as shown inFIG. 1B. With the plunger pressed down and the guide taking a slender profile, theguide10 is inserted through the tissue, particularly through a surgical wound or opening. Theplunger21 is released and the expandingfeet26 are placed against the peritoneal wall (FIG. 3).
• With theguide10 inserted through the trocar wound and secured to the inner wall, attention is turned to theneedle apparatus49 which also functions as a suture engaging device. Thelockout trigger52 is released to partially extend the snare57 (FIG. 4B). InFIG. 9, a section ofsuture160 is placed intowire snare57. As shown inFIGS. 4A and 5A, thelockout trigger52 is actuated and thesnare57 is retracted to capture the section ofsuture160 within the distal tip of theneedle apparatus49.
• InFIG. 10, theneedle apparatus49 is then placed through one of the guide barrelneedle entry slots27, through theneedle tunnels35 in theplunger21, out theneedle exit slots28, and through thetissue36,37,38 into theabdominal cavity162. Thelockout trigger52 is released (seeFIGS. 4B and 5b), deploying thesnare57. Theneedle apparatus49 can then be further advanced into thecavity162 to release the section ofsuture160. Thelockout trigger52 is again actuated to retract thesnare57, and theneedle apparatus49 is removed from theguide10 and tissue layers36,37,38. Theneedle apparatus49 is then inserted into the opposingneedle entry slots27 of theguide10 and through the tissue layers36,37,38. Thelockout trigger52 is released to partially deploy thewire snare57. Theslide rod53 is fully translated into theneedle housing50 to fully deploy thesnare57. Theneedle49 can then be rotated or manipulated to place thesnare57 underneath the free end of thesuture160.
• InFIG. 11, theneedle apparatus49 is then slightly pulled proximally to encircle thesuture160 inside thesnare57. Theslide rod53 is pulled back proximally to the spring-biased rest position, and thelockout trigger52 is actuated to capture thesuture160 in the tip of theneedle apparatus49. Theneedle apparatus49 is then pulled out of the body and guide10. One last time thelockout trigger52 is released to partially extend thesnare57. Thesuture160 is then removed from thesnare57. The guide is then removed to freely expose the suture ends. A knot is tied between the two free ends of thesuture160 that is used to close the wound site.
• FIG. 12 illustrates apreferred method200 for insufflating a body cavity and engaging a suture to close a wound using a single device. Themethod200 comprises the step210 of insufflating the body cavity with a shaft defining an insufflation channel along an axis between a shaft distal end and a shaft proximal end. Step220 comprises securing a suture with a snare disposed adjacent to the shaft distal end. In step230, the shaft with the secured suture is inserted into the body cavity at a desired first location. A guide may be used in step230 to direct the device to the desired first location. In step240, the suture is released by moving, or actuating, the snare to an exposed position, which may be a partially exposed or fully exposed position. Step250 comprises removing the shaft from the first location.
• In step260, the shaft is inserted into the body cavity at a desired second location spaced apart from the first location. The guide may be used in step260 to direct the shaft to the second location. Step270 comprises capturing the suture with the snare. Instep270, the snare may be actuated to a fully exposed position to enlarge the loop and orient the loop substantially perpendicular to the axis of the shaft. Step280 comprises securing the suture to the shaft by retracting the snare. Step290 comprises removing the shaft from the second location with the secured suture to complete a stitch loop.
• FIG. 13 illustrates apreferred method300 for closing a surgical wound using a system comprising preferred embodiments of a guide and a suture engaging device disclosed above. It will be appreciated that thismethod300 enables an operator to deploy and capture suture using simply a guide and a suture engaging device without the need for a grasper. Themethod300 comprises the step310 of actuating a guide into a slender configuration and inserting the guide through surgical wound. Step315 comprises radially expanding a securing mechanism, which may comprise feet or living hinges, at a distal end of the guide. Step320 comprises retracting the guide such that the securing mechanism engages an inner body cavity wall surrounding the wound. Instep325, unwanted tissue is separated away from exits formed in the guide in order to prevent said tissue from being sutured. Step325 may be accomplished with axial wings formed on an outer surface of the guide adjacent to the exit slots.
• Step330 comprises engaging a suture with a snare disposed at a distal end of a suture engaging device having a shaft. Instep330, the snare is actuated to a fully retracted position to capture and lock the suture. Step335 comprises inserting the suture engaging device with the secured suture through a first track of the guide and into the body cavity at a first position. Step340 comprises releasing the suture in the body cavity and retracting the suture engaging device from the first track of the guide. Step345 comprises inserting the suture engaging device through a second track of the guide and into the body cavity at a second position laterally spaced from the first position. InStep350, the snare may be deployed up to a fully exposed configuration to capture the suture. In the fully exposed configuration, the loop is substantially perpendicular to the axis of the shaft of the suture engaging device. Step355 comprises retracting the snare to secure the suture. Step360 retracting the suture engaging device with the secured suture from the guide to complete a stitch loop.
• FIG. 14 illustrates a second preferred embodiment of aneedle apparatus400 comprising asingle actuator452 as opposed to dual actuators included in the first preferred needle apparatus discussed above. In this secondpreferred needle apparatus400, theactuator452 comprises alockout trigger452 coupled to a rod assembly448 that is coupled to asnare457. Whereas in the first preferred needle apparatus, the lockout trigger is capable of moving the snare between a retracted position to a partially exposed position, thelockout trigger452 in the secondpreferred needle apparatus400 is capable of moving thesnare457 between a retracted position, where thetrigger452 is moved to the most proximal position as shown inFIG. 15, and a fully exposed position, where the trigger is moved to the most distal position as shown inFIG. 14.
• Thelockout trigger452 rides along atop slot476 and a pair of side tracks475 formed in thehousing450. Since thelockout trigger452 needs to translate a greater distance with respect to the housing, particularly in the proximal direction, theslot476 andtracks475 are formed with greater lengths than those of the firstpreferred needle apparatus49.
• Accordingly, theslide rod53 of the firstpreferred needle apparatus49 shown inFIGS. 6A-6C, has been omitted in the secondpreferred needle apparatus400 and replaced by thesingle lockout trigger452. Furthermore, the second preferred needle apparatus comprises a402 which may be formed integrally with or separately from thehousing450. Thehandle402 defines afinger slot403. Except for structural differences discussed above with respect toFIGS. 14-15, all other structures in the secondpreferred needle apparatus400 as well as the principles of operation are substantially similar to those in the firstpreferred needle apparatus49.
• 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 as defined by the following claims. For example, notwithstanding the fact that the elements of a claim are set forth below in a certain combination, it must be expressly understood that the invention includes other combinations of fewer, more or different ones of the disclosed elements.
• 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 by special definition in this specification the generic structure, material or acts of which they represent a single species.
• The definitions of the words or elements of the following claims are, therefore, defined in this specification to not only include the combination of elements which are literally set forth. In this sense it is therefore contemplated that an equivalent substitution of two or more elements may be made for any one of the elements in the claims below or that a single element may be substituted for two or more elements in a claim. Although elements may be described above as acting in certain combinations and even initially claimed as such, it is to be expressly understood that one or more elements from a claimed combination can in some cases be excised from the combination and that the claimed combination may be directed to a subcombination or variation of a sub combination.
• Insubstantial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalently within the scope of the claims. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements. The claims are thus to be understood to include what is specifically illustrated and described above, what is conceptually equivalent, what can be obviously substituted and also what incorporates the essential idea of the invention.

Claims (24)

1. A dual insufflation and closure device for use in connection with a surgery involving an open wound, comprising:

a shaft assembly defining a lumen extending along an axis between a shaft distal end and a shaft proximal end, the lumen configured to be in fluid communication with a source of pressurized fluid; and

a puncture closure mechanism configured to engage a suture.

2. The device ofclaim 1, wherein the puncture closure mechanism comprises a snare disposed adjacent to the shaft distal end, the snare being movable between a retracted position where the snare is substantially disposed within the shaft assembly and an exposed position where the snare protrudes from the shaft assembly.

3. The device ofclaim 2, wherein the snare comprises a deformable loop composed of a material having memory characteristics such that the snare forms a pre-formed shape when exposed.

4. The device ofclaim 3, wherein the deformable loop in the exposed position is slanted with respect to the axis of the shaft.

5. The device ofclaim 3, wherein the deformable loop forms an opening substantially perpendicular with respect to the axis of the shaft.

6. The device ofclaim 2, further comprising an actuator mechanism for moving the snare between the retracted position and the exposed position.

7. The device ofclaim 6, further comprising:

a housing disposed adjacent to the shaft proximal end, the housing having a housing proximal portion and a housing distal portion, and

wherein the actuator mechanism comprises a rod assembly coupled to the snare, the rod including a rod proximal portion protruding from the housing proximal portion, the rod assembly being configured to axially translate more than 1 inch with respect to the housing.

8. The device ofclaim 7, wherein the actuator mechanism comprises a trigger configured to lock the snare in the retracted position.

9. The device ofclaim 2, wherein the shaft assembly comprises:

an outer shaft having a sharp needle distal tip; and

an inner shaft comprising the lumen and housing the snare.

10. The device ofclaim 9, further comprising a distally biased obturator tip to shield the needle distal tip when the obturator tip encounters a drop in resistance.

11. A dual insufflation and closure device for use in connection with a surgery involving an open wound, comprising:

a shaft assembly defining a lumen along an axis between a shaft distal end and a shaft proximal end;

a snare configured to engage a suture and disposed adjacent to the shaft distal end, the snare being movable between a retracted position where the snare is substantially disposed within the shaft assembly and a fully exposed position where the snare protrudes from the shaft assembly;

a housing having a housing proximal portion and a housing distal portion; and

an actuator mechanism for moving the snare between the retracted position and the fully exposed position.

12. The device ofclaim 11, wherein the snare comprises a deformable loop composed of a material having memory characteristics such that the snare forms a pre-formed shape when exposed.

13. The device ofclaim 11, wherein the deformable loop in the fully exposed position is off-axis.

14. The device ofclaim 11, wherein the actuator mechanism comprises a rod assembly coupled to the snare and configured to slide axially with respect to the housing between a proximal retracted configuration and a distal exposed configuration.

15. The device ofclaim 14, wherein the rod is configured to slide more than 1 inch axially with respect to the housing.

16. The device ofclaim 11, further comprising a lock mechanism configured to secure the snare in the retracted position.

17. The device ofclaim 11, wherein the shaft assembly comprises a sharp needle distal tip.

18. The device ofclaim 17, further comprising a distally biased obturator tip to shield the needle distal tip when the obturator tip encounters a drop in resistance.

19. The device ofclaim 11, wherein the actuator mechanism moves the snare between the retracted position, a fixed partially exposed position and the fully exposed potion.

20. A method for insufflating a body cavity and engaging a suture to close a wound open to the body cavity using a single device, comprising:

insufflating the body cavity with a shaft defining an insufflation channel along an axis between a shaft distal end and a shaft proximal end;

securing a suture with a snare disposed adjacent to the shaft distal end;

inserting the shaft with the secured suture into the body cavity at a desired first location;

releasing the suture by moving the snare to an exposed position;

removing the shaft from the first location;

inserting the shaft into the body cavity at a desired second location spaced apart from the first location;

capturing the suture with the snare;

securing the suture to the shaft by retracting the snare; and

removing the shaft from the second location with the secured suture to complete a stitch loop.

21. The method ofclaim 20, wherein the step of releasing the suture by moving the snare to the exposed position comprises moving the snare to a fixed partially exposed position.

22. The method ofclaim 21, wherein the step of capturing the suture with the snare comprises moving the snare to a fully exposed position.

23. The method ofclaim 20, wherein:

the step of releasing the suture by moving the snare to the exposed position comprises moving an actuator mechanism in a distal direction with respect to a housing coupled to the actuator; and

the step of capturing the suture with the snare comprises moving the actuator in a proximal direction with respect to the housing.

24. The method ofclaim 20, wherein:

the step of inserting the shaft with the secured suture into the body cavity at the desired first location further comprises inserting a needle distal tip of the shaft through a body wall and shielding the needle distal tip of the shaft upon exiting the body wall; and

the step of inserting the shaft with the secured suture into the body cavity at the desired second location spaced apart from the first location further comprises inserting the needle distal tip of the shaft through the body wall and shielding the needle distal tip of the shaft upon exiting the body wall.

Images