2012-03-15 Assigned to INSIGHTRA MEDICAL reassignment INSIGHTRA MEDICAL ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BELL, STEPHEN GRAHAM, AMATO, GIUSEPPE, NODA, WAYNE A.
This invention relates to a surgical implant system for repairing abdominal hernias and is particularly useful for repairing ventral hernias. In particular, the present invention relates to an implant, a delivery device and a method for implanting the implant. The implant is implanted in a substantially slackened condition relative to the ventral wall.
This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 60/013,619, filed Dec. 13, 2007, and U.S. Provisional Application No. 61/030,439, filed Feb. 21, 2008 the entire contents of which are hereby expressly incorporated by reference.
This invention relates to a surgical implant system for repairing abdominal hernias and is particularly useful for repairing ventral hernias. In particular, the present invention relates to an implant, an implant securement device, a delivery device and a method for implanting the implant.
A hernia is a rupture of the abdominal wall which normally provides support for internal body organs. In conventional procedure for repairing a hernia, an incision is made over the site of the hernia, the internal viscera are pushed back into the abdominal cavity and the incision is closed by stitching or suturing one side firmly to the other. However this suturing can distort sensitive tissue, cause tension and subsequent pain, and often is not a permanent repair.
Thus there is a need for an improved device and method for the treatment of ventral hernias and particularly one that reinforces the herniation, is secured to the ventral wall without tension and allows for tissue movement around the repair site.
The present invention provides for an improved device, system and method for the repair of ventral hernia and may solve the needs in the art stated above and may provide certain advantages over the prior art.
In one embodiment of the invention is a surgical implant having a tension free implant member that has at least one engagement member extending from the implant member. This engagement member is adapted to fixate the implant to at least a portion of the ventral wall such that when implanted the implant is in a substantially slackened condition relative to the ventral wall. The implant may be sized to be substantially larger than the hernia and may be a mesh that is made from a synthetic material, a biological material or a combination of materials.
In another embodiment of the invention the engagement member may comprise a strap, cord, suture or mesh. The engagement member may have a connector to connect the engagement member to the implant member. This connection is such that the engagement member may be fixated in an abdominal cavity independently from the implant member and then coupled to the implant member. The engagement member may have a piercing element such as a trocar, barb, hook, needle or guidewire, attached to one end that is designed to assist in securing the implant to the ventral wall.
In another embodiment, the engagement member may have a detachable zone formed from two ends joined together with a removable cord such that when the cord is removed or cut the two ends separate.
Another embodiment of the invention details a delivery device for securing an engagement member to the ventral wall and having a passer configured to penetrate at least a portion of the ventral wall. This passer may have a connector adapted to couple to the engagement member to pull the engagement member through the ventral wall. The passer may have a curved radius and a pivot point such that as the passer is advanced, the distal end penetrates tissue in a circular path. In use, when the passer is retracted, the engagement member is pulled through the circular path by the connector which may surround a tendon, bone, ligament, fascial tissue or a portion of muscle. Alternatively the passer may be made from a super elastic alloy having a pre-set radius with the passer confined by an outer tube such that as the passer is advanced from the tube, the distal end penetrates tissue in a substantially circular path which may surround a tendon, bone, ligament, fascial tissue or muscle portion.
In another embodiment of the invention the placement of the engagement member may be guided by the finger of the operator such that tactile feel of the operator can guide the apparatus to an particular anatomical position. And in another embodiment of the invention the placement of the engagement member may be guided by positioning the instrument using a light source coupled to a distal end of the instrument such that an operator can position the distal end by visualizing the light source through the skin.
Another embodiment of the invention is an apparatus for securing the engagement member to a portion of a ventral wall using a passer that may have an end adapted to penetrate the ventral wall in a substantially circular path when advanced. The apparatus may also have a strap tube that is connected to the engagement member and disposed about the passer. The apparatus may have a pusher also disposed about the passer with the pusher adapted to push the strap tube along the circular path of the passer.
In another embodiment the invention is a surgical kit containing an implant member, at least one engagement member and a delivery device for coupling the engagement member to at least a portion of a ventral wall. The kit may further include a passer with a distal end that is configured to penetrate a portion of the ventral wall. The kit may further include a connector attached to the passer end and adapted to couple to the engagement member so that the engagement member can be pulled through a portion of the ventral wall with the retraction of the passer. When the implant is secured to the ventral wall it may be in a substantially slackened condition relative to the ventral wall. The kit may also have a tunnel member with a drape attached to a wide opening of the funnel with one end of the funnel sized for placement into a surgical incision. The funnel member may have a retention ring formed adjacent to the narrow opening to retain the funnel in the incision.
Another embodiment of the invention is a method of treating a ventral wall hernia including the steps of creating an incision in the ventral wall, placing an implant having at least one engagement member into or along the interior ventral wall such that the implant is in a slackened condition relative to the ventral wall. The method may include pulling the engagement member through the ventral wall and through the skin. The method may also include detaching the engagement member from the implant prior to placement of the implant and pulling the engagement member first through the skin and ventral wall and attaching the engagement member to the implant. The method may also include pulling the engagement member through or around a tissue structure such as an abdominal muscle, ligament, tendon, or bone.
The method may also include positioning a delivery device having a passer adjacent a portion of a tissue structure and passing the passer through at least a portion of the tissue structure in a generally circular path. The method further including coupling a connector disposed at the distal end of the passer to an engagement member and pulling the engagement member through the tissue structure along the generally circular path by retracting the passer and connector.
Another embodiment of the invention may be a method including the steps of positioning an instrument having a passer in or alongside the ventral wall, passing the passer through a tissue structure of the ventral wail. The method including advancing a strap tube which is disposed about the passer and to which is connected to a distal portion an engagement member along the path of the passer by using a pusher.
Another embodiment of the invention is a method for treating a ventral wall hernia including the steps of creating an incision in the ventral wall, placing an implant having at least one set of opposing engagement members into or alongside the ventral wall and securing the implant to the ventral wall such that the implant is in a slackened condition relative to the ventral wall. The method may also include pulling the engagement members through the posterior ventral muscle fascia, around the ventral muscle and through the anterior ventral muscle fascia and then joining the opposing ends of the at least one set of engagement members together. An alternative embodiment of the method may include pulling the engagement members through the posterior ventral muscle fascia, around the ventral muscle and joining the opposing ends of the at least one set of engagement members together at a location disposed between the ventral muscle and the anterior ventral muscle fascia.
It is understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed. The accompanying drawings illustrating an embodiment of the invention and together with the description serve to explain the principles of the invention.
FIG. 11 is a perspective view of an embodiment of a surgical implant showing retention tube.
FIG. 14 is a view of an implant template positioned on the skin of a patient over a ventral hernia.
Although many different devices and several different methods of accessing and repairing abdominal hernias and in particular ventral wall hernias have been tried, including surgical and laparoscopic procedures, a better device and method is needed. Particularly a device that can be easily implanted and secured across the ventral wall and a device that allows for changes in the configuration and tone of the ventral wall as the hernia defect heals and remodels is necessary.
An implant and implantation method that permit small incisions, that can be implanted in a substantially slackened condition and have tension-free engagement members to accommodate changes in the healing/remodeling of the ventral wall may lead to better outcomes.
Although the repair of ventral hernias is particularly referenced, it is anticipated that the apparatus and methods described herein may be used for other surgical or laparoscopic procedures whereby a tissue structure of the human body requires strengthening or supporting.
The delivery devices described are applicable to hernia repair but may be used wherever a strap, cord, engagement member or suture needs to be passed through a tissue of the body. Although shown in the ventral portion of the abdominal wall and although so described for treatment of ventral hernias, the apparatus and methods shown may be used for inguinal hernias, pelvic support, and other areas of the body.
Many other hernia repair devices are positioned in the hernia and then fixated in place using rigid clips, sutures or staples. These fasteners securely attach the implant to the abdominal wall and prevent migration of an implant over time. However these securement practices do not allow for the expansion or contraction of the surrounding tissue as part of the healing process. It has been found that the tissues of the abdominal wall change over time as the tissues heal and as abdominal wall tissue invades the implant, particularly a mesh implant. While this cell in-growth may provide a cell impregnated structure that is strong and biocompatible, it is also inflexible and incapable of accommodating tissue movement or expansion. In particular scar tissue typically forms and as it develops the tissues surrounding an implant may be pulled and stretched due to shrinkage of the encapsulated mesh. If an implant is directly and rigidly stapled or clamped to the ventral wall, these rigid attachments can tear out over time resulting in the potential for a reoccurrence of the hernia and discomfort for the patient.
Therefore one preferred embodiment of the invention is configured to be implanted into an abdominal cavity in such a way that a tension free condition results. This tension free condition is one in which the implant is placed into position with sufficient slack so that as surrounding tissue expands or moves, this implant slack can be used to avoid pulling and possible tearing of surrounding tissue that may result from an implant that is too tight or does not have any residual slack. Additionally, the implant may be configured with engagement members or straps that are used to at least temporarily secure the implant to the surrounding tissue and retain mesh orientation. These engagement members may be secured to tissue such that they are tension free. Tension free means that these straps are not rigidly secured to tissue with a staple or clip but rather are held in place by friction generated between the engagement member and surrounding tissue. In this condition these members secure and stabilize the implant but also permit some movement of the engagement member relative to surrounding tissues over time. The tension free engagement members and the oversized implant with substantial slack allow for longer term natural abdominal wall remodeling which is may be particularly important to reduce and fix the hernia. It is believed that this type of tension free implant may promote better healing, reduce premature tear-out or dislodgement or dislocation and provide increased comfort and acceptance by the patient.
Referring to FIG. 1, there is shown a cross-sectional view of a normal, anterior abdominal wall of the ventral region of the body. The abdominal wall includes left and right rectus muscles 10 and 12 enclosed and held in place by posterior layers of fascia 14 and anterior layers of fascia 16. These layers of fascia, which are thin, strong fibrous tissue, merge together in the region intermediate the rectus muscles 10 and 12. A thin layer 18, called the peritoneum, covers the posterior side of the posterior fascia 12. The peritoneum 18 is a soft, pliable layer of tissue material and provides an enclosure for the intestines and other internal viscera. A layer of skin composed of the sub dermis 20 and dermis 22 covers the exterior of the anterior fascia 16. FIG. 1B illustrates a condition where a hernia has formed in the wall of the abdomen. The hernial opening is shown at 24. In this example, the hernia is formed by the rupture of the fascia layers 14 and 16 in the region intermediate the rectus muscles 10 and 12. This rupture permits the internal viscera to push the peritoneum 18 in an outward direction, creating a bulge 24 in the skin layers 20 and 22. If not treated, the condition will only worsen with time, with the peritoneal bulge becoming larger.
Referring now to FIG. 2, there is shown a surgical implant or a hernia repair device 28 comprised of an implant member 30, also referred to as an implant, and having at least one flexible engagement member 32A-E extending from the side of the implant. The implant 30 may be constructed of a solid or a permeable material. The implant 30 may have various shapes. An example of a permeable material is a mesh that may be receptive to tissue ingrowth. Suitable materials for making the mesh may be: polypropylene mesh such as that distributed by C. R. Bard, Inc. of Murray Hill, N.J. under the trade name "Marlex"; a polyethylene mesh material of the type distributed by E. I. Du Pont de Nemours and Company of Wilmington, Del. under the trade name "Alathon"; and a Dacron mesh material or a Nylon mesh material of the type distributed by E. I. Du Pont de Nemours and Company of Wilmington, Del. Additionally the mesh may be constructed from a metallic mesh or a polymer mesh having interwoven metallic filaments. These filaments may provide additional strength to the mesh or make the mesh radiopaque for later visualization. The mesh may be a single layer or have a multilayer construction. The mesh may have one or more layers constructed from a bioabsorbable material such that the mesh may be reabsorbed by the body over time. The mesh may have one or more layers constructed from a layer having anti-adhesion properties such that ingrowth or attachment of tissue to the mesh is inhibited. One or more layers may also be coated with an anti-adhesional coating that is applied to a surface to inhibit tissue attachment. These anti adhesional characteristics may be particularly useful for those implant surfaces that are exposed to the internal viscera of the abdominal cavity. In this situation it may be helpful to inhibit potential attachment of various organs to the implant. This may be particularly possible if the innermost surface of the ventral wall, the peritoneum 18, is compromised. One example of an adhesion resistant material is, for example, a thread of polytetrafluoroethylene polymer material of the type sold under the trade name "Gore-Tex" by W. L. Gore & Associates, Inc.
The implant 30 may be made initially oversized compared to the size of the hernia. The implant may be sized substantially larger than the area of the hernia and may comprise an area equivalent to the area encompassed by a patient's diaphragm and pubis in one direction and the lateral sides of a patient's abdomen in the other direction. A large implant 30 may improve adhesion to the abdominal wall. An implant sized substantially larger than the hernia may preferably be 1.5 times larger than the area of the hernia, or more preferably two times larger than the area of the hernia, or most preferably multiple times the size of the hernia area. In another embodiment the implant is oversized compared to the area of the hernia, but the implant 30 is trimmable. That is the implant may be trimmed in situ to fit the size of the hernia. In this way one implant size may be provided to the user and then the implant custom trimmed to fit the surgical conditions.
The engagement member 32A-E may be used to secure the implant 30 to the ventral wall and if more than one engagement member 32 is used then they are preferably symmetrically arranged around the perimeter of the implant 30. Although five engagement members 32A, 32B, 32C, 32D, and 32E are shown in FIG. 2, this is for descriptive purposes only. The apparatus 28 may use one, two, four or more engagement members. The placement of the member may be at an apex of the implant 30 or evenly spaced around the perimeter. The member may be integrally formed as an extension of the implant 30 or may be a separate piece that is formed from the same material as the implant 30. The member and the implant 30 may also be constructed from different materials. The member may be identified with unique identifying characteristics so that one member may be discerned from another. In this way a member corresponding to a particular location on the implant may be identified By way of example that is not meant to be limiting, each member may have a different color coding so that when the implant is inside the abdominal space, the orientation of the implant may be discerned and correct positioning of the members to avoid entanglement can be realized.
The engagement member may have different configurations and the device 28 may utilize one configuration only for a particular implant or multiple configurations may be utilized on a single implant. However the engagement member is generally flexible and not rigid. While other prior art devices utilize stiff and rigid engagement type members and especially rigid placement needles or trocars, the present invention is flexible. The members are adapted to pass through ventral wall tissue structures such as the posterior and anterior fascia layers 14 and 16, rectus muscles 10 and 12, sub dermis 20 and dermis 22. Member 32A is shown as a woven mesh that is integrally formed as an extension of the implant mesh 30. In this configuration the member 32A is a mesh strap that may extend 2-20 inches from the perimeter of the implant 30. As can be shown the member 32A has a tapered end 33 that reduces the width of the strap to taper to a point of attachment to a piercing element 34. The piercing element 34 is formed as a part of the strap or may be attached at end 33. The piercing member has a sharpened end adapted to pierce tissue structures so that the member 32A may be pulled through the tissue structures similar to a needle and thread using a delivery device to be illustrated later. Alternatively the member 32A may be pushed through the tissue structures. The piercing member may be a trocar, barb, hook, needle or a passer element such as a guidewire.
Engagement member 32B having an inner end 35 and an outer end 36, is shown coupled to the implant 30 at inner end 35. Inner end 35 is located interiorly from the perimeter of the implant 30. This attachment location may facilitate trimming the implant area at the interventional site because the attachment point is set apart from the edge that might be trimmed. The attachment location could be located anywhere on the implant and is not limited to a particular location. Secondly, member 32B is not integral to the implant 30 but is a separate member. Member 32B is attached to the implant with a connector 37 at the end 35 of the member 32B. This member may be deployed as part of the implant or may be decoupled from the implant and re-coupled later. This configuration of implant allows separate placement of the member and implant. In some situations it may be preferable to position the member 32B prior to insertion of the implant. In other situations it may be preferable to position the member after the implant is positioned. The connector 37 may be any type of mechanical connector, magnetic connector, adhesive or other connector. Some examples of mechanical connectors are hooks, snaps, threaded sections, bayonet fastener, hook and loop type fastener, snares, buttons, suture, or clamps although any type of connector may be suitable and this list is not meant to be limiting.
Engagement member 32B also has a detachment zone 38 that is the coupling zone for the member 32B and the extension element 40. Extension element 40 has inner and an outer ends 41 and 42. The inner end 41 of the extension element 40 is coupled to the outer end 36 with the use of cord 44. The cord 44 may be a thread, suture or other similar material configured so that the two described ends 36 and 41 can be coupled by loosely tying them together. An end of the cord 46 may extend outside the body. Together the engagement member 32B and the extension 40 provide a long enough length of strap so that the combination can be used to tension the implant by pulling the extension element 40 from outside the body. However, once the implant is tensioned properly any excess engagement member is unnecessary and is often removed so that the end of the engagement member can be positioned inside the incision. Therefore the excess may be cut away but the optimal cutting point may be deep inside the ventral wall and difficult to reach especially with a small incision. Therefore the detachment zone 38 is intended to provide a remote method of detaching unneeded length of the engagement member that is inside the incision. The cord 44 may be severed at the detachable zone 38 with a blade or may be released by pulling on the cord end 46 from outside the body. In another embodiment of the invention the engagement member 32B terminates at outer end 36 and extension element 40 is not present. However cord 44 may still be threaded through the outer end 36 only. Tension may be applied to the engagement member by pulling on the cord 44. After proper positioning and tensioning of the implant 30, the cord may be removed from the engagement member 32B by pulling on the cord end 46 so that the outer end 36 remains inside the ventral wall cavity.
In another embodiment of the engagement member 32C, the width of the member is reduced to facilitate pulling the engagement member through various tissue structures. The reduced lateral profile may reduce friction and the resultant force required to pull or push the engagement member. The engagement member 32C profile may be reduced by spinning, forming or winding the member 32C material into a smaller diameter and thereby forming a cord or leader. The engagement member 32C profile may be reduced by the use of a sleeve 50 disposed around the member. Such a sleeve 50 may be made of polyethylene, polypropylene, nylon, silicone or other suitable polymer that may be useful to reduce the friction as the engagement member passes through tissue structures. The sleeve 50 may be made from a shrink tubing. Engagement member 32C may have all or a part of its length comprised of a leader 52. This leader may be made of suture, cord, string, wire or other suitable flexible material. This leader 52 may be coupled directly to the implant 30 or may comprise a portion of the engagement member 32C. The leader may terminate at its outer end with a piercing member 34 as shown previously.
The outer end of the engagement member may also terminate with an anchor 54 or 56 attached to engagement members 32D and 32E. Engagement members 32D and 32E may be positioned in a tissue structure either by pushing or pulling the members as will be shown. These members' outer ends enter tissue structures and then anchor into the tissue to secure the engagement member to the tissue. Various anchor designs are anticipated and the anchors 54 and 56 are not meant to be limiting. Anchor 54 is shown having lateral barbs 55 that may have a fixed configuration or these barbs may be deployable after positioning. The anchor 56 is a barbed hook which may pass easily into tissue and then inhibit reverse movement to prevent pullout of the anchor and engagement member.
Referring now to FIG. 3A, shown is a cross-sectional view of a herniated ventral wall prepared for positioning of an implant. An incision 70 has been made along the midline preferably along a line running from the diaphragm to the pubis and laterally; toward the sides of the abdomen. The incision size may be smaller than other surgeries since the securement of the implant utilizes engagement straps to secure the implant to the ventral wall and the kit may include a delivery device that is capable of securing the engagement member from inside a small incision. This eliminates the current method of suturing which often requires more access.
The incision size may also be smaller than other surgeries since the securement of the implant and does not utilize bulky staplers to secure the implant 30 to the ventral wall. Direct placement of larger implants or the use of staplers may require more operating space and thus a larger incision size than contemplated with this apparatus. The tissue has been dissected down to the level of the peritoneum 18 and a pocket or cavity 72 has been formed between the posterior fascia 14 and the peritoneum 18 to receive the implant. Preferably the implant is placed into a pocket 72 as described however other pocket locations such as between the fascia and the rectus muscle, between the recs muscle and the anterior fascia or between portions of the skin are also possible. If the peritoneum 18 is not continuous, the peritoneum may be approximated before implant placement. If such approximation is not possible, then the implant may be implanted without a pocket and may be placed along the posterior side of the peritoneum if necessary. Various implant configurations described previously including those having anti-adhesion coatings or layers may be used if the peritoneum is not continuous. These coatings or layers are intended to inhibit attachment of the implant to internal viscera.
As shown in FIG. 3B, an implant 30 has been sized and positioned in pocket 72. The implant may be made having one size and then may be cut and trimmed in situ so that the implant is properly sized according to the size of the pocket formed. However several different sized implants may be made to accommodate various pocket and hernia sizes expected. The implant 30 is positioned between the peritoneum 18 and the posterior fascia 14 and is secured in position by engagement members 74 a and 74 b.
As shown the implant is implanted in a substantially slackened condition as shown by the large gaps indicated by open double arrows shown between implant 30 and the peritoneum 18 and the posterior fascia 14. An implant that is positioned with a slackened condition means that the implant is not tight against tissue structures but is loosely positioned and gaps are present between the implant and these tissue structures. This slack may be useful as the surrounding tissue moves or expands as a result of the healing process. The slack means no tension is made when the mesh and tissue ingrowth shrink this eliminates pain associated with current repairs that great massive tension on the sutures or staples.
This slack may be reduced as the ingrowth tissue shrinks and contracts. The gaps shown may be equivalent to between one implant thickness and multiple implant thicknesses. The amount of slack in the implant may be directly observed through the incision 70 and may be adjusted by extending or retracting the engagement members 74 a and 74 b from the tissue structures. As shown, the engagement members are secured by friction generated between the member and the tissue structure. The members may be secured to the tissue by using a curved pathway through the tissue to increase the friction described. Alternately the members may utilize barbs or serrations to increase the securement of the members to surrounding tissue.
As shown by the single arrow, the engagement member 74 a is deployed through the entire ventral wall by pushing the flexible engagement member 74 a having a piercing member 34 at its outer end 76. This piercing element 34 pierces tissue and facilitates insertion through the various tissue layers previously described This type of placement may be referred to as an in/out technique in that the member passes from inside the body toward the outside of the body. The engagement member 74 a extends past the dermis and the tension on the implant 30 may be adjusted by pulling on the outer end 76 of the member. Thus once the member 74 a is pushed through the skin by a physician, the outer end 76 may be pulled as the implant slack is visualized through the incision 70 until the desired slackened condition is reached. The engagement members are thus in a "tension-free" condition in that they are not rigidly anchored to tissue structures with sutures, clips or staples as other devices. However the pathway through the tissue structures provides enough friction on the engagement members to secure them and the attached implant in place. Engagement member 74 a is shown extending through the entire ventral wall and exiting through the skin but the member 74 a may extend only partially through the ventral wall.
Engagement member 74 b is shown with the outer end and piercing element removed and the new end 77 positioned subcutaneously. Once the engagement member 74 a is inserted through the ventral wall and the implant 30 tensioned appropriately, the outer end 76 and piercing element 34 may be removed and the end 77 tucked under the skin using common surgical practice. Although two engagement members are shown, any number of members may be used to secure an implant. Preferably two, or four or six members may be used to secure the implant to the ventral wall.
Turning now to FIG. 3C, alternative configurations of apparatus and method may be utilized to secure the engagement member to surrounding tissue structures. Engagement member 78 a is shown deployed partially through the ventral wall and terminating in the rectus muscle. A complete puncture of the skin may not be required to secure the implant. Various portions of the ventral wall may be used to secure the member 78 a. Also other tissue structures may be used to secure the member. For example tendon, bone, ligament, fascial tissue or various muscle portions may be used to secure the member. The member may encircle these structures to increase the surface area contact, increase the friction, and provide a stable anchor point and thus the holding strength of the member on the implant.
In another embodiment, an engagement member 78 b is deployed through the posterior fascia, rectus muscle, anterior fascia and then through the incision opening 70. In this configuration, the outer end of the engagement member 78 b is easily accessible so that the outer end may be pulled to tension the implant. Excess member material may be removed and the end tucked inside the incision 70.
Alternately an engagement member may be inserted from outside the body through the skin to the implant. This type of placement may be referred to as an out/in technique in that the member passes from outside the body toward the inside of the body. As shown in FIG. 3D, an engagement member 80 a is partially deployed through the skin in the direction of the arrow. The member 80 a has a piercing element 34 at the end to facilitate insertion of the member 80 a through the ventral wall. The member 80 a may have a connector located at the same end to connect with the implant 30 once the member 80 a is fully positioned. Alternatively the piercing element 34 may also function as a securement device. An example of this may be a barbed hook. Once attached to the implant, the member may be pulled in a direction opposite the arrow to tension the implant. Similarly to engagement member 74 b, the outer end of the member may be removed and the end tucked under the skin as engagement member 80 b.
Referring to FIGS. 4A-C, three embodiments of a delivery device to position an engagement member are illustrated. Such a delivery device and method may be used to position an engagement member in a tissue structure through a confined space with little visibility such as found in the incision and small pocket described previously. An intended benefit of the described delivery device and method is to position an engagement member as previously described through a smaller incision as with other devices.
The delivery device 100 includes a housing 102 having a cavity 104 disposed at its distal end 106. A curvilinear passer 108 having an inner end 109 and an outer end 110 is disposed inside the housing 102. The outer end 110 is sharpened to facilitate passage through tissue structures. The inner end 109 is coupled to the housing 102 at a rotating pivot 112 so that the passer can rotate about this pivot in a generally circular pathway. The term circular path is meant to include generally curved paths and other path shapes that are not considered straight or substantially straight, and paths that generally extend from the cavity 104 to the housing 102 as will be shown. The passer 108 is rotatably linked to an actuator 114 at linkage 116 and the actuator is slidably disposed inside the housing. The outer end 110 of the passer may also have a connector 118 that is adapted to couple to an engagement member.
As shown in FIGS. 5A-C, the delivery device 100 of FIG. 4A is positioned at the delivery site with the cavity facing the direction of activation. As the actuator 114 is moved toward the distal end 106, the passer 108 is driven through the linkage 116 and pivots around the pivot 112. The passer then moves in a generally circular pathway that conforms to the shape of the passer into or around tissue structures 117 located inside or adjacent the cavity. The mechanism may be useful to drive the passer 108 around tissue structures 117 such as tendon, bone, ligament, fascial tissue or portions of muscle. As the passer traverses in a generally circular pathway, it may couple with an end of an engagement member 119 by passing the connector 118 through the engagement member that has been positioned nearby. The connector shown is a barbed hook that penetrates the mesh of the engagement member 119.
Once the engagement member 119 is coupled to the connector 118, the actuator may be retracted away from the distal end 106 which also retracts the passer 108. This movement pulls the engagement member 119 along the generally circular pathway of the passer, and back into the housing. The delivery device 100 may be withdrawn in the direction of the arrow, pulling the engagement member through or around the tissue structures. In the case of ventral hernia repair, the delivery device 100 maybe used to position the engagement members in or around various tissue structures such as the fascia layers, rectus muscles, and dermis and sub dermis layers.
An alternate delivery device 130 is shown in FIG. 4B including a housing 132 having a tapered end 133 with a passer 134 slidably disposed inside. The passer 134 may have a sharpened end 136 and a connector 138 to couple with an engagement device. The passer is made from a curved superelastic alloy such as Nitinol. The passer 134 is restrained inside the housing and when advanced outside the housing, the passer assumes a curved shape. The passer is driven through tissue structures as it is further advanced from the housing traversing a generally circular pathway. The connector 138 located at the sharpened end 136 is adapted to couple with an engagement member such that as the passer is retracted inside the housing 132, the engagement member (not shown) is pulled through the generally circular pathway of the passer. The mechanism may be useful to drive the passer around tissue structures such as tendon, bone, ligament, fascial tissue or portions of muscle. The delivery device 130 may be withdrawn pulling the engagement member through the tissue structures. In the case of ventral hernia repair, the delivery device 130 maybe used to position the engagement members in various tissue structures such as the fascia layers, rectus muscles, and dermis and sub dermis layers.
An alternate delivery device 140 is shown in FIG. 4C having a passer 142 comprising an elongate hollow housing 144 coupled with a steerable end portion 146. Disposed inside the hollow housing are at least two controlling wires 147 a-b that extend to the proximal end. These controlling wires are attached to the steerable end portion 146 such that by relaxing one wire and pulling another the steerable end portion may be actuated to steer the steerable end portion 146 in a particular direction. As can be seen, if the wires are positioned next to a tissue structure and actuated to form a curved configuration, as the passer 142 is advanced the passer will traverse through a generally circular pathway. The passer may have a sharpened end 148 and a connector 149 located at the end. The connector 149 is adapted to couple with an engagement member such that as the passer 142 is retracted and the steerable end portion is straightened, the engagement member (not shown) is pulled through the generally circular pathway. The delivery device 140 may be withdrawn pulling the engagement member through the tissue structures. In the case of ventral hernia repair, the delivery device 140 maybe used to position the engagement members in various tissue structures such as the fascia layers, rectus muscles, and dermis and sub dermis layers.
Alternate connectors are illustrated in FIGS. 6A-C that may be useful to connect a previously described passer with an engagement member. A connector 150 is shown attached to a passer 152 similar to those discussed. The connector 150 may be a magnet tip that is configured to mate with a magnetic receiver 154 attached to an engagement member 155. As the magnetic tip passes through tissue structures and approaches the magnetic receiver 154, a magnetic coupling occurs and the engagement member 155 is detachably joined to the connector and passer. The magnetic coupling should be strong enough to maintain the coupling as the passer is withdrawn pulling the engagement member 155 through tissue structures.
Also shown is connector 160 attached to a passer (not shown) similar to those discussed. The connector 160 may be a threaded rod 162 that is configured to mate with a similarly threaded tube 164 attached to an engagement member 165. As the threaded rod 162 passes through tissue structures and approaches the threaded tube 164, the two may be coupled by screwing the two together and the engagement member 165 is detachably joined to the connector 160. The threaded coupling should be strong enough to maintain the coupling as the passer is withdrawn pulling the engagement member 165 through tissue structures.
An alternate embodiment of an engagement member delivery device 200 is shown in FIGS. 7A-D having an elongate hollow body 201 enclosing an elongate tubular housing 202 that may freely slide along the transverse axis of the body 201. The housing 202 has a guide 204 comprising an elongate flexible curvilinear rod disposed therein. The guide 204 is adapted to assume a generally circular shape when not constrained inside the housing. The guide 204 has a tip 206 configured to penetrate tissue structures of the body. The delivery device 200 further comprises a strap tube 208 and a tubular pusher 210 disposed coaxially about the outside of the housing such that both may slide along the transverse axis of the housing. The strap tube 208 has distal 210 and proximal 211 end portions with the distal end portion configured to couple to a catch 212 located at an opening 214 in the body. The catch is adapted to secure the strap tube to the body 201 as will be shown. The strap tube 208 has an engagement member 216 attached to the proximal end 211.
In use, the body 201 is introduced into the abdomen and the guide 204 is extended from the housing 202 such that the guide makes a generally circular pathway through and around tissue structures 218 and enters the opening 214 in the body 201. The housing 202 is then extended from the body and the strap tube 208 is pushed from the housing along the guide 204 by the pusher 210. The strap tube 208 is pushed through tissue structures 218 while following the guide until it enters the opening 214 and is captured by the catch 212. At this point the strap tube is coupled to the body 201. The guide, pusher and housing are retracted back into the body and the body removed from the abdominal space As can be seen, as the body is withdrawn, the engagement member 216 is positioned through and around tissue structures 218.
The device of FIGS. 5, 6 and 7 may be positioned and used in such a way that the engagement member 119, 155 or 216 respectively is secured to ventral tissue structures. As shown in FIG. 7E, the engagement members, which may or may not have a leader 220 attached to one end, may be secured to the ventral tissue structures by delivering the engagement member through these tissues in a generally circular pathway shown by arrow 222 with the end of the engagement member protruding through the incision. Again this pathway is generally circular meaning that the pathway is not substantially straight. The engagement member traverses through an arc such that the engagement member may pass into and then through tissue adjacent to the initial placement of the implant and then again exit this same tissue so that an end of the engagement member may be withdrawn with the device and exit at least partially through the incision as shown at least partially in FIG. 11.
As shown in FIGS. 8A-D, the various delivery devices previously described may be made with various shapes and rigidities to facilitate placement of the delivery device in the abdominal space. The delivery device 230 is a generally straight and rigid device with a handle 231 connected at the proximal end. Delivery device 232 has an angular offset bend along its length that may be useful in certain anatomical conditions and delivery device 234 has a general curvilinear shape. Alternatively the delivery device 236 may be flexible and not rigid or may be steerable by the operator.
All the delivery devices previously described may be placed in the abdominal space using positioning aids to guide and direct the placement of the engagement members. These aids may utilize tactile or visual feedback to the operator so that tissue structures such as arteries, veins, nerves, bone, ligaments or tendons in the body can be identified and the placement of the engagement member may be properly directed compared to a blind approach. Referring to FIGS. 9A-C, the delivery device may have a finger loop 250 configured at the distal end such that an operator may place a finger into the loop and utilize tactile feeling in the finger to guide placement of the delivery device end. The finger loop 250 may be attached to the delivery device at point 251 using adhesive or mechanical attachments. The finger loop 250 may also be integrally formed as part of the delivery device. Similarly, the delivery device 252 may have a light source 254 attached to the outer body of the delivery device 252. This light source may be an LED light source and be adapted to radiate a generally confined narrow beam of light. This light may be directed such that the light may be seen through the skin. In this way the operator can utilize the light as a marker to guide positioning as described. In another embodiment the delivery device may be constructed with loops 260 to couple an endoscope 262 to the delivery device. In this way the placement and delivery of engagement members using the delivery device may be controlled through direct visualization by the operator.
Multiple engagement members may be used to secure an implant to the ventral wall. These engagement members may have cords or leaders that extend from the distal ends of the engagement members that may be used to tension the implant. Keeping these ends organized and identified may be challenging. Additionally the sterility of all of these loose ends and the implant must be maintained in a crowded surgical site. To organize and identify the various cords coming from the members, the leaders themselves or the engagement members may be color coded, shape coated or in some other way uniquely identified so that an individual engagement member and its location to the implant and the ventral wall can be determined.
A device to organize the method of implanting the implant and providing a large sterile barrier is illustrated in FIG. 10. A funnel 300 is shown positioned in the incision of a ventral hernia procedure. The hourglass shaped funnel 300 has a wide opening 302 and a narrow opening 304 positioned in the incision and a narrowed neck in between. The funnel may have a straight taper configuration or other configurations as well. The narrow opening 304 may have a retention ring 308 that has an outer diameter greater than the narrow opening 304. The retention ring 308 outer diameter is sized so that once placed into the incision, it retains the funnel 300 in the incision and prevents inadvertent dislodgement of the tunnel from the incision. A drape 310 is attached to the wide opening 302 and extends radially outward from the opening. The drape and funnel may be packaged sterile and the drape is sized to cover an extended surgical area. As can be appreciated when the narrow opening 304 of a sterile funnel is inserted into an incision and the drape extended, an effective sterile barrier is created so that an implant 312 having multiple engagement members 314 may be inserted through the funnel and into the pocket in a sterile, organized manner. Furthermore the engagement members 314 or leaders attached to the ends of the engagement members may be threaded back through the funnel after positioning into a tissue structure. When the end of an engagement member 314 is pulled to apply tension to the implant 312, the inside of the retention ring 304 may act as a fulcrum point and protect the incision edge from abrasion from the member 314. The excess length of the engagement member may be removed, the funnel and drape removed and the incision closed to complete the operation. The excess length may be particularly removed by severing or removing the cord 44 located in a detachment zone 38 as shown in FIG. 2.
In another embodiment of the device and method, after positioning the implant and the engagement members and after the engagement members ends are threaded through the wide opening 302 of the funnel 300, the funnel and drape of FIG. 10 may be removed. The funnel may then be replaced with a small retention tube 320 into which the ends of the engagement members 322 are threaded. The retention tube has a small outside diameter that is sized to allow a smaller incision opening 323 than that required for the funnel. Whereas the funnel opening is larger to accommodate the implant and all of the engagement members, the retention tube is sized to accommodate just the engagement member ends which may be only cords, leaders or sutures. The smaller diameter of the retention tube 320 allows for nearly the complete closure of the incision. The retention tube functions similarly to the funnel because when the end of an engagement member such as member 322 is pulled to apply tension to an implant such as implant 324, the inside of the retention tube may act as a fulcrum point and protect the incision edge from abrasion from the member 322. The excess length of the engagement member 322 may be removed using detachment methods previously described, the retention tube removed and the incision closed to complete the operation.
A tissue structure 340 punctured with an engagement member 342 is shown in FIG. 12. The placement and securement of the engagement member through or around a issue structure 340 may be augmented by directly fastening the engagement member 342 to the tissue structure 340 with the use of staples, clamps, adhesives, sutures or other fastening devices 344. These fasteners 344 insure that the member will not pull out or move relative to the tissue structure. Alternatively the placement and securement of the engagement member 342 through or around tissue structure 340 may be augmented by indirectly fastening the engagement member to the tissue structure with the use of staples, clamps, adhesives, sutures or other fastening devices. In this embodiment the tissue opening around the engagement member 342 is narrowed to pinch the member and further secure the member.
An alternative embodiment of the device is an implant and method that are illustrated in FIGS. 13A-B. An incision is made along the midline preferably along a line running from the diaphragm to the pubis and laterally toward the sides of the abdomen. The tissue is dissected down to the level of the peritoneum and an implant 400 is positioned in a pocket 406 formed in a portion of the ventral wall. Preferably this pocket 406 is formed between the peritoneum 408 and the posterior ventral muscle fascia 409 but if no peritoneum is present the implant 400 could be positioned along the posterior ventral muscle fascia 409. The implant 400 is similar to implant 30 and is implanted in a substantially slackened condition relative to the ventral wall as has been previously described. The implant 400 has at least two engagement members 402 a-b extending from the implant perimeter and adapted to be inserted through adjoining tissue structures to secure the implant. Specifically the engagement members 402 a-b are either pulled or pushed to traverse the posterior ventral muscle fascia 409, the rectus muscle 410 and the anterior ventral muscle fascia 411. The tension and slack of the implant may be adjusted by extending or retracting the engagement members in the tissue structures. The ends of the at least two engagement members are coupled together to secure the implant to the tissue structures described. The engagement members 402 a-b may be coupled using suitable fasteners 404 such as suture, mechanical fasteners, hook and loop fasteners otherwise known by the commercial name Velcro®, or adhesives. This list of fasteners is not meant to be limiting and any fastener system commonly known in the art can be used. Any excess length of engagement member may be removed and the incision closed.
In an alternative embodiment of the method, after positioning the implant 400 in the pocket 406, the engagement straps 412 a-b are either pulled or pushed to traverse the posterior ventral muscle fascia 409, the rectus muscle 410 and are positioned between the rectus muscle 410 and the anterior ventral muscle fascia 411. The tension and slack of the implant may be adjusted by extending or retracting the engagement members in the tissue structures. The ends of the at least two engagement members are coupled together to secure the implant to the tissue structures described.
An alternate embodiment of the method of using the implant is shown in FIG. 14. A template 250 may be used before or during the procedure to mark the intended position of the engagement members of the implant. The template 250 is positioned over the incision 252 with the general outline of the template 254 lying on the skin of the patient. The outline 254 corresponds to the size of the implant. The location of the engagement members 256 are shown by the dotted segments. The operator places the template on the skin of the patient over the hernia and marks the locations of the engagement members on the skin of the patient. After the template is removed, these marks may guide the placement of the engagement members through the ventral wall of the patient.
This invention has been described and specific examples of the invention have been portrayed. The use of those specifics is not intended to limit the invention in anyway. Additionally, to the extent that there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is our intent that this patent will cover those variations as well.
a tension free implant member having at least one engagement member extending from the implant member and adapted to fixate the implant to at least a portion of the ventral wall such that when implanted the implant is in a substantially slackened condition relative to the ventral wall.
2. The implant member of claim 1 further comprising a mesh that is made from a synthetic material, a biological material or a combination of materials.
3. The implant member of claim 1 further comprising a mesh that is made from a bioabsorbable material.
4. The implant member of claim 1 further comprising a metallic mesh or a polymer mesh having interwoven metallic filaments.
5. The implant member of claim 1 further comprising at least one layer, wherein one side of said layer is adapted to resist adhesion of the implant to adjacent organs or tissue.
6. The engagement member of claim 1 further comprising a strap, cord, suture or mesh and having an inner and an outer end.
7. The engagement member of claim 6 wherein the inner end of the member includes a connector configured to detachably connect the engagement member to the implant member such that the engagement member may be fixated in an abdominal cavity independently from the implant member and then coupled to the implant member.
8. The connector of claim 7 comprising a mechanical fastener, hook and loop type fastener patch, button, suture, magnetic fastener, adhesive or clamp.
9. The engagement member of claim 6 wherein the engagement member is made from a material different than that of the implant member.
and a piercing element attached to an end of the outer portion that is configured to pierce at least a portion of the ventral wall.
11. The piercing element of claim 10, wherein the piercing element is coupled to the outer portion via a suture or leader.
12. The piercing element of claim 10 comprising a trocar, barb, hook, needle or passer such as a guidewire.
13. The engagement member of claim 6 further comprising a detachable zone disposed between the inner and outer portions, said zone having an inner face and an outer face that are joined together with a removable cord such that when the cord is removed or cut the inner and outer portions of the engagement member separate.
14. The engagement member of claim 6 further comprising an anchor coupled to the outer end.
and said passer adapted to pull the engagement member through the path when retracted.
16. The delivery device of claim 15, further comprising a pivot and an actuator coupled to the passer, said passer having a curved radius and configured such that as the actuator is advanced, the passer rotates about the pivot in a generally circular path.
17. The circular path of claim 15, wherein the path encircles a tendon, bone, ligament, fascial tissue or muscle portion.
19. The apparatus of claim 15, wherein the connector couples to the engagement member using a mechanical coupler.
20. The mechanical coupler of claim 19, further comprising a barb, a threaded connector, a snap, a bayonet system, a latch or a jaw.
21. The delivery device of claim 15, wherein the device is flexible and may have a preset or flexible shape.
22. The passer of claim 15, wherein the passer is made from a super elastic alloy having a pre-set radius, the passer confined by an outer tube and configured such that as the passer is advanced from the tube, the distal end penetrates tissue in a generally circular path.
23. The substantially circular path of claim 22, wherein the path encircles a tendon, bone, ligament, fascial tissue or muscle portion.
24. The apparatus of claim 15 further comprising a finger holder configured to retain a finger of an operator such that tactile feel of the operator can guide the delivery device to an anatomical position.
25. The apparatus of claim 15 further comprising a light source attached to the delivery device and configured such that the light penetrates the ventral wall to aid positioning of the delivery device to an anatomical position.
a pusher also disposed about the guide between the proximal end and the strap tube, and said pusher adapted to push the strap tube along the path of the guide.
27. The apparatus of claim 26 further comprising a body disposed about the strap tube, guide and pusher, the strap tube adapted to couple with said body after passing through said path.
28. The substantially circular path of claim 26, wherein the path encircles a tendon, bone, ligament, fascial tissue or muscle portion.
29. The apparatus of claim 28 wherein the guide is a guidewire.
31. The kit of claim 30, wherein said kit is adapted to secure the implant to the ventral wall such that when implanted the implant is in a substantially slackened condition relative to the ventral wall.
32. The delivery device of claim 30, further comprising a pivot and an actuator coupled to the passer, said passer having a curved radius and configured such that as the actuator is advanced, the passer rotates about the pivot in a generally circular path.
33. The circular path of claim 32, wherein the path encircles a tendon, bone, ligament, fascial tissue or muscle portion.
the funnel having a wide opening forming an opening in the drape and sized for placement into a surgical incision and further adapted to receive the implant.
35. The funnel of claim 34, further comprising a retention ring formed at the narrow opening that is configured to retain the funnel in the incision, said funnel configured to enable the engagement member to pass through the narrow neck after passing through the portion of the ventral wall so that the tension of the implant may be adjusted by pulling on the engagement member against the retention ring.
36. The surgical kit of claim 35, further comprising a retention tube, said tube adapted for placement into the incision after removal of the funnel and configured to receive leaders connected to an end of the engagement member so that the leaders may be pulled to adjust the engagement member tension.
placing an implant having at least one engagement member into the wall or along an interior surface of the wall and securing the implant to the wall such that the implant is in a slackened condition relative to the wall.
38. The securing method of claim 37, further comprising pulling the engagement member through at least a portion of the ventral wall such that the engagement member is secured to the wall by friction between the member and the wall.
39. The securing method of claim 38, further comprising forming a pocket for the implant in the ventral wall, said pocket being larger than the hernia, placing the implant into the pocket, and pulling the engagement member from the pocket and through at least a portion of the ventral wall.
40. The securing method of claim 39, wherein after the member is pulled through a portion of the ventral wall, the member is in a slackened condition relative to the implant.
41. The securing method of claim 38, further comprising forming a pocket for the implant in the ventral wall, detaching the engagement member from the implant prior to placement of the implant into the pocket, pulling the engagement member from outside the body, through the skin and ventral wall and then attaching the engagement member to the implant.
coupling the connector to the engagement member and pulling the engagement member through the portion of the ventral wall along the path.
43. The securing method of claim 42, further comprising pulling the engagement member around or through a tissue structure such as an abdominal muscle, fascial tissue, ligament, tendon, or bone.
advancing a strap tube connected to a distal portion of the engagement member and disposed about the guide along the path of the guide by using a pusher.
45. The method of claim 38, including augmenting the engagement member securement by directly fastening the engagement member to the tissue structure with the use of staples, clamps, adhesives, sutures or other fastening devices.
46. The method of claim 38, comprising indirectly augmenting the engagement member securement by reducing the opening created by the engagement member through the ventral wall with the use of staples, clamps, adhesives, sutures or other fastening devices to increase the tissue interference with the engagement member.
47. The method of claim 42, further comprising positioning the instrument using a finger guided cradle coupled to a distal end of the instrument such that an operator can position the distal end using a tactile feedback.
48. The method of claim 42, further comprising positioning the instrument using a light source coupled to a distal end of the instrument such that an operator can position the distal end by visualizing the light source through the skin.
49. The method of claim 42, further comprising positioning the instrument using an endoscope coupled to a distal end of the instrument.
50. The method of claim 38, comprising placing drawstring sutures in the peritoneum to plicate the peritoneum prior to positioning the implant.
pulling a free end of the engagement member back through the funnel after securing the engagement member to a portion of the ventral wall.
52. The method of claim 51, further comprising securing the funnel member in the incision with a retention ring formed at the narrow opening.
using the template to mark the location of the securement of the engagement member.
placing an implant having at least one set of opposing engagement members into the pocket and securing the implant to the ventral wall such that the implant is in a slackened condition relative to the ventral wall.
and joining opposing ends of the engagement members together.
56. The securing method of claim 54, further comprising pulling the engagement members through the posterior ventral muscle fascia, around the ventral muscle and joining the opposing ends of the engagement members together on top of the anterior ventral muscle fascia.


Spring awakening – what's happening in the woods?
Spring is in the air, the snowdrops are making way for the daffodils and the forests and woods of the Blackdown Hills AONB are waking from their winter tranquillity. Bluebells and pimpernel are already poking their heads from the soil now and, despite mixed weather, we're welcoming lots of visitors to our sites.
It's a very special time of year for wildlife and our forests. As nature wakes up, the days are gradually staying lighter for longer, presenting more opportunity for us all to spend much needed time immersing ourselves in the great outdoors and enjoying the associated wellbeing benefits. It's a time for new ventures, new life and the perfect opportunity to come and visit some of the spectacular woodland on offer in the Blackdown Hills.
As the weather improves (storms aside!), I love to watch our forests grow in popularity. It isn't surprising, thanks to spectacular views on offer from Castle Neroche and Staple Hill, and the cool temperatures under the woodland canopy offering much needed shelter on hot summer days. Our woodlands attract families seeking adventures, outdoor and active enthusiasts, as well as wildlife and survey experts. And with the influx of human visitors, we also look forward to seeing a growing number of furry friends enjoy the sights, sounds and smells of the forest.
One of my challenges, at this time of year, is helping our visitors – both two- and four-legged – to stick to the Countryside Code by leaving only footsteps when they depart. I know we all agree that our beautiful forests look more attractive without plastic bags piled next to signage, gateways and hanging from trees. And the health risks to people and wildlife of un-bagged dog waste are well known.
So, what are we doing to help our poo-ches and their humans?
With the support of local residents and visitors, we will be installing a number of dog poo bins and setting up regular collections at some of our most heavily visited sites. Whenever possible, we still encourage you to take your pup's waste home to put in your general rubbish. When this isn't possible, we hope that the introduction of waste bins will help ensure that Forestry Commission sites in the Blackdown Hills remain safe and attractive places for people to visit, explore and enjoy the wonders of our woodland.
Clean forests support amazing wildlife and the Forestry Commission will be working with Blackdown Hills AONB, British Trust for Ornithology and local amphibian and reptile groups in the coming months to survey for adder and nightjar. We'll be seeking volunteers to help with these projects, so keep an eye on our local Forestry Commission Facebook page and the Blackdown Hills AONB website's volunteering page for opportunities to get involved and support your local wildlife. We will hopefully see you there!


pour l't. Voyages-sncf : Bnficiez de la livraison de vos. Nike : 10 de rduction pour les tudiants Valable. Code rduction: Codes promo en ligne pour obtenir les meilleurs prix. Chaque code de reduction est vrifi avant publication afin de vous faciliter l'obtention des promotions et profitez de bons plans sans perdre de temps.
Vous propose uniquement les codes promo les plus rcents et ensuite les codes expirs qui peuvent souvent encore tre actifs. Another advantage of shorter code is that it's more readable, though as you've pointed out, you can overdo it to the point where readability actually starts to suffer. The problem isn't your understanding of when code reduction is good and when it's not, the problem is dogmatism in applying what is normally a reasonable practice indiscriminately. Pour trouver les codes de rduction de votre boutique prfre, il est conseill d'utiliser la barre de recherche pour consulter directement la page du marchand concern. There's a lot of answers here code de reduction ecce gusto that address the technical pros and cons of keeping LOC down and whether or not it's a meaningful quality software metric. Removing variables that give context to what the code means and replacing them with literals that don't is a very very bad thing.


There are many paths to adopting a child each of which has a unique set of expenses. Some of those options are more affordable than others. There are also great resources to make adoption accessible to as many willing adoptive parents as possible. Adoption will certainly require serious commitment and sacrifice on your part but if you are serious about making it happen it is within your reach.
This is a hard question to answer because there simply is no single answer. Every adoption has a unique set of circumstances and expenses. There is a lot of good information out there about what to expect expenses to be on average but it's hard to know ahead of time exactly what your adoption will end up costing. The data that is out there can give you a ballpark idea about what kind of budget you will need. This is very helpful when you are evaluating whether to start the adoption journey or not.
Melissa and I want to be transparent about the financials of our adoption journey for the sake of education and building awareness. We think the more people know about adoption and how much it costs, the better we as a culture and as a global church can embrace and promote adoption. We are expecting the total cost of our adoption process to be in the ballpark of $30,000 to $35,000. That is just the expense of making the adoption happen but does not include some other expenses that we are incurring in order to expand our family. Examples of the additional expenses are a larger vehicle, some improvements in our apartment, another car seat, another crib, etc… I wrote a post about the specific finances of our adoption titled "Actively Waiting" if you are interested in hearing more about our personal journey.
An adoption in the United States today is likely to cost somewhere in the range of $0 to $50,000. That's a huge range! $0 sounds great to me. Then on the other end of the spectrum, $50,000 is a down payment on a nice house in some parts of the country or a new luxury vehicle. As you can see from the size of that range, the path of adoption that you end up pursuing will have a tremendous impact on how much it costs.
On the more affordable (~$0) end of that spectrum is a means of adopting called "foster to adopt" or "foster/adopt." Adopting through foster/adopt involves enrolling in your County's foster care program and providing foster care for a child with the intent of eventually adopting them. The actual adoption will happen if and when it becomes legally possible. In the foster/adopt process the adoption will be legally possible once the child's birth parents have either permanently lost the parental rights to their child or have voluntarily surrender those rights. Foster/adopt is an amazing program which allows orphaned, abused and neglected children to be placed in permanent stable and (hopefully) loving homes. There are many reasons why this is both an admirable and challenging path to pursue adoption through. The foster/adopt program is a route that Melissa and I are seriously considering and praying about for future adoptions. It isn't what we believe we are being called to for this adoption.
The foster/adopt path to adoption is the most affordable option because it is a part of the social services that are provided by your County's child and family services department. These services are paid for by you and I, the taxpayers. You may end up having to pay a few hundred to a couple thousand dollars in legal fees and/or travel expenses but that will likely be the extent of your expenses.
The path that Melissa and I have chosen for our current adoption is what is called a domestic agency adoption. This means that we will be adopting a child domestically (in the United States) and that our child's birth mother (or parents) will have voluntarily placed their child up for adoption through a private agency rather than involving the County.
Adoption through an agency is generally more expensive than foster/adopt for a number of reasons. The simplest reason is that agency adoption is not directly funded with taxpayer money. The adoptive parents are responsible for most of the expenses involved in completing the process of adopting through an agency.
Domestic infant adoptions are likely to cost anywhere from $5,000 in some cases up to $50,000 in others. According to AdoptionHelp.org, the average cost of adopting domestically through a non-profit licensed agency is $10,000 – $25,000.
Another very common path for adoption is to adopt a child from an orphanage in another country. This is commonly referred to as "International Adoption." The process for adopting internationally can vary tremendously depending on which country you are adopting from. The range that I have seen quoted is $10,000 to $40,000 on average for an international adoption. International adoptions may cost more than domestic because you have to pay for more complicated and long distance travel as well as legal and government fees in two countries. You will often need to work with multiple organizations in order to complete the adoption which also each have their own staff and expenses to pay for.
This is another hard question to get a clear answer for. I would love see a dollar for dollar breakdown of exactly what gets paid for in a $30,000 (or $50,000!) adoption process. While I haven't found that kind of detailed breakdown, I have started to piece together a good understanding of why adoptions cost so much. When you start adding up all of the line items involved it becomes easy to see how you can get to a number like $30,000 or $40,000.
Adoption is the permanent legal transfer of parenthood over a human being from one set of parents to another set of parents. This process is overseen and regulated at the state and federal level. It is a process with significant emotional and psychological impact for all of parties involved and should be handled with great care under professional supervision.
This is just my own description of the adoption process with emphasis added for the components of that process which contribute to its expense.
Let's talk about some of the specific expenses that are involved.
There are many people involved in most adoptions. Many of those people are professionals who are paid salaries. Those people work in offices which must be paid for and heated or cooled. There are many hours of work that go into any single adoption. There are attorneys involved and as a result legal fees. There are also logistics related expenses for the adoptive parents. Expenses like paying for documents, fingerprints and background checks. As well as the cost of traveling to the hospital where the child is born.
Additionally, the birth mothers will often (though not always) receive assistance with their own medical expenses. They may receive professional counseling through the adoption agency. Sometimes they receive help with living expenses during their pregnancy.
There are a ton of individual expenses that quickly add up and contribute to the overall expense of adoption.
There are a lot of resources out there to help you fund your adoption. Loans, grants, fundraising platforms, etc… Do a little research and you will find more options than you know what to do with. A few Google searches go a long way.
One of the largest sources of help with financing an adoption that is available to everyone is the Federal tax credit. It's currently around ~$12,000 that the Federal government will credit you on your tax return in order to reimburse you for adoption expenses. This is a huge help for anyone that is adopting in the United States.
One way to raise funds to help pay for your adoption is to reach out to your network of family and friends and ask for help. If fundraising is something you are considering, we really like AdoptTogether.org which is a really cool crowd-funding platform for adoptive families. You can see our own AdoptTogether.org profile here. Coming to the decision to raise funds in order to finance our own adoption was not an easy decision. However, I am learning that there is a lot of beauty and humility to be found in being willing to say "We need help!" when facing something as monumental as the process and expense of adoption. I would encourage you to seriously consider reaching out to your family, friends and spiritual community if you need help.
There is another important issue that I want to address regarding funding adoption. The fee structure and total cost that a licensed adoption agency will charge for handling an adoption is not something that is regulated at either the state or federal level in the United States. This allows each agency to structure their fees the way that they see fit. This freedom and flexibility can be a good thing for upstanding agencies with morally upright founders who work to make adoptions smooth, healthy processes for everyone involved and want to place as many children in good homes as possible. However, that freedom can also allow for ethically questionable agencies to prey on adoptive and birth parents in order to make money in the process.
One of the most intimidating aspects of this process for me has been not knowing how much we should be willing to pay for an adoption or who to trust. At the start of this process I had no idea how to judge if the expenses we were being asked to pay were in fact fair or reasonable. I personally want every penny we pay to in some way benefit the wholeness of the adoption process and to go towards helping the birth parent(s) and our adopted child.
I think that it is SO important for you to do a lot of research and do your best to make sure you adopt through reputable, honest and financially efficient organizations. These organizations should only charge you fair and legitimate costs which are in fact contributing to the quality and wholeness of the adoption process.
Try to get several referrals from others who have worked with the organization. The ideal scenario would be to get referrals from both sides of the adoption equation. Referrals from adoptive parents may be easier to come by. It will likely be difficult to find referrals from birth parents as there are privacy and legal issues issues involved. The agency may not be able to put you in touch directly with either adoptive parents or birth parents. You may need to do online research and ask around in order to find people to talk to. Some birth mothers do end up writing about their experiences or concerns online so a little online research can go a long ways.
Learn a little about how to read a non-profit's 990 tax form and look into organizations such as org who evaluate the financial reports of various non-profits. Most reputable adoption agencies will be non-profit organizations and as such are required to file a 990 tax form with the IRS. They are required to make this form available to the general public as well. While this form won't give you a definitive answer on whether an organization is completely ethical or not, it will allow you to look for red flags which you can choose to either dig into or may just prompt you to steer clear of a questionable organization.
As Melissa wrote about in Our Path of Adoption, we decided to work with an adoption consultant. We made this decision partially in order to help us navigate some of these ethical questions and concerns. So far we are very happy with that decision and feel good about our adoption process and the expenses involved.
If you have any specific questions about funding an adoption please feel free to connect with us. You can always reach us via the contact button at the top of the blog. We would be happy to share everything we know and also try to point you to people who know things we just haven't learned yet. I hope that the information I have shared is more helpful and informative than overwhelming for you.
If there is one thing I hope you have taken away it's that while funding an adoption can feel overwhelming you should not let it scare you away from what is an amazing and life-changing experience. The financial component of adoption can feel like a huge burden but I promise that if you choose jump over the mental hurdle of "How will we ever afford this?" and start looking into the practical ways you can make an adoption happen you will get there.


Comment: Gulfport Storage, a great place to rent. The new owner made it so, along with his management team, especially Scott, who is so responsive to ensure all is well. Richard and Kevin work with him to make a good team.
Comment: I can only give rave reviews about Gulfport Storage and their employees! During a recent visit we ended up with some great Florida finds we could not transport "back home" at that time. We looked up online and found this lovely, well-groomed facility and decided to give you a try. Needless to say we are extremely pleased we chose Gulfport and will use your facilities again soon! A personal thank you goes out to Richard and Scott, who showed jewel customer service.
Comment: Scott the Manager has been terrific to deal with. Always pleasant and ready to go the extra mile for you!
Comment: Good place. Like kevin.
Comment: Outstanding people working here.
Comment: Nice storage units option electrical units. Owners will work with you on upgrades. Public restroom for clients.


text:
Role of Predicted Metalloprotease Motif of Jab1/Csn5 in Cleavage of Nedd8 from Cul1
Gregory A. Cope1,
Greg S. B. Suh3,*,
L. Aravind4,
Sylvia E. Schwarz1,†,
S. Lawrence Zipursky2,3,
Eugene V. Koonin4,
Raymond J. Deshaies1,2,‡
1 Department of Biology, California Institute of Technology (CalTech), Pasadena, CA 91125, USA.
2 Howard Hughes Medical Institute,
3 Department of Biological Chemistry, The School of Medicine, University of California at Los Angeles (UCLA), Los Angeles, CA 90095, USA.
4 National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health, Bethesda, MD 20894, USA.
Gregory A. Cope
Greg S. B. Suh
L. Aravind
Sylvia E. Schwarz
S. Lawrence Zipursky
Eugene V. Koonin
Raymond J. Deshaies
COP9 signalosome (CSN) cleaves the ubiquitin-like protein Nedd8 from the Cul1 subunit of SCF ubiquitin ligases. The Jab1/MPN domain metalloenzyme (JAMM) motif in the Jab1/Csn5 subunit was found to underlie CSN's Nedd8 isopeptidase activity. JAMM is found in proteins from archaea, bacteria, and eukaryotes, including the Rpn11 subunit of the 26S proteasome. Metal chelators and point mutations within JAMM abolished CSN-dependent cleavage of Nedd8 from Cul1, yet had little effect on CSN complex assembly. Optimal SCF activity in yeast and both viability and proper photoreceptor cell (R cell) development in Drosophila melanogaster required an intact Csn5 JAMM domain. We propose that JAMM isopeptidases play important roles in a variety of physiological pathways.
↵* Present address: Department of Biology, California Institute of Technology, Pasadena, CA 91125, USA.
↵† Present address: G2M Cancer Drugs AG, Frankfurt/Main, Germany.
↵‡ To whom correspondence should be addressed. E-mail: deshaies{at}caltech.edu
You are going to email the following Role of Predicted Metalloprotease Motif of Jab1/Csn5 in Cleavage of Nedd8 from Cul1
By Gregory A. Cope, Greg S. B. Suh, L. Aravind, Sylvia E. Schwarz, S. Lawrence Zipursky, Eugene V. Koonin, Raymond J. Deshaies
Science 18 Oct 2002 : 608-611

redpajama_set_name: RedPajamaCommonCrawl


Connection and configuation of panel buttons and wiring the inverter to the control board.
The MB2 breakout board has a relay which is used to switch the spindle on and off. This is connected to the inverter with two wires to the FOR and common terminal. It is possible to add a second set of wiring for operating the spindle in reverse, however this is not installed as this machine only runs in one direction.
The panel buttons have two parts. The switches are momentary and each one is wired to a separate input.
The button LEDs are connected to outputs, so that they will turn on/off in response to the contoller, and not just the fact that a button has been pressed.
For the buttons to work, some program code must be added to both the Signal script and the Screen Load script. Both scripts are accessed from the 'screen editor' within Mach4.
This code runs when any signal changes state, and refers to the SigLib table in the screen load script.
The SigLib table contains the inputs and associated commands for each button. This example is for the Cycle Start button which is wired to input 16. When the state of input 16 changes to 1 (i.e. the button is pressed), the command CycleStart() runs.
For other buttons the code is identical, just change the 16 to the appropriate input number, and 'CycleStart()' to the command required when the button is pressed.
This code or a very similar example should already exist in the scripts, typically commented out with -- at the start of each line.


Here you can find track previews from release Hide N Seek (feat. Estee Nack) - Single by artist Sharp. This album was released 08.06.2018 and containing 1 tracks. Listen online Sharp - Hide N Seek (feat. Estee Nack) - Single previews (30 seconds length) is free and don't require registration. For buy album Sharp - Hide N Seek (feat. Estee Nack) - Single please follow to music stores. If we have other releases and albums Sharp you can see it on this page. All music content by Sharp is presented for reference only.


Stalls are filling up fast and there a just a few spaces left for traders wanting to get involved when the Lincoln Teenage Market comes to Louth this May.
As well as marking the start of Love Your Local Market Fortnight, Saturday May 18, will see Louth host its first Teenage Market event.
The market is being organised by East Lindsey District Council in partnership with Bishop Grosseteste University, who run the Lincoln Teenage Market, and will be held alongside Louth's regular Saturday market; giving the young traders a true flavour of what trading on a market is like.
Confirmed traders are coming from across Lincolnshire, and will be offering a real variety of products, including multimedia paintings, photography and engraved glass products. In addition to the traders, there will also be a range of entertainers attending, with a DJ, a dance group and a circus skills workshop all confirmed so far.
There are still some spaces for entertainers available, and anyone wishing to take part as an entertainer or trader should go to www.theteenagemarket.co.uk and search for the Lincoln Teenage Market events.
Special thanks go to Louth Independent Traders and The King's Head Hotel in Louth, who are kindly sponsoring the Teenage Market.
Thanks also go to Larders Coffee Shop, Clarks Shoes, Eve and Ranshaw, Annikas and Spar, who have all kindly contributed prizes for the free prize draw which will take place on the day. If you're interested in donating a prize for the prize draw, email teenagemarket@bishopg.ac.uk.
ELDC's Economic Development Officer, Samantha Phillips, said: "It's wonderful to see that so many young traders have taken the opportunity to get involved with this unique market. This event is all about inspiring the next generation of market trader in East Lindsey and hopefully we'll see some of the traders coming back in the future.
"I'd also like to say a massive thank you to the businesses who have gotten involved, kindly providing sponsorship or donating to the prize draw, events like this rely on support from local businesses and it is great to see so many getting involved".
Becky Goodman, Enterprise Development Manager, and Nikki Smith, Careers, Employability and Enterprise Adviser at BG Futures, said: "We are delighted to bring The Lincoln Teenage Market on tour to Louth.
Gary Dennis, chairman of Louth Independent Traders, said: "We are delighted to be able to support Louth's first Teenage Market.


People race in these. On baseball diamonds. Really.
Big Bear Lake has a little something for everyone, young and old, people seeking an adventure or just coming to relax, for outdoor and indoor activities. We look forward to each and every season, since each season offers new ways to have fun and try new things in the mountains or in the Village. Right now we really love the fishing, golfing, and watery fun that the lake and surrounding area has to offer. This week we look at challenging Big Bear…and exploring the area's past.
Are you getting ready for some big rides around Big Bear Lake? August 4th will be a bicycle rider's day, with two big events rolled into one! A revamped Tour de Big Bear will be going on that day, with rides of twenty five, fifty, seventy, and one hundred miles available for all riders. Spots are going quickly, so make sure you sign up soon.
Part of the tour will be the Open Air Big Bear Classic, the third component in the Conquer the Bear series of events. There will be two designated courses for the challenge, one of twenty four miles (for the Cub challenge) and one of forty one miles (for the Bear and Grizzly challenge). This is the third in the series of four adventures to expose you to all the area has to offer.
The Old Miners are at it again, keeping the summer party going at Big Bear Lake! The Old Miners' Bluegrass and Country Music Festival is kicking off this Friday and continuing through the weekend. You can see Riders of the Purple Sage, The Wimberley Bluegrass Band, and more acts will be playing all weekend long.
The festival provides more than great bluegrass music in Big Bear – on Saturday you can treat yourself so a few other events that have become staples of the Old Miners Days Festival. Starting at 9 AM you can see the Burro Softball Tournament, and after the games you can witness the grand spectacle of Outhouse Races! A little bit later in the day, you are will want to bring your lawn chair and sunscreen for the 2012 Big Bear Heritage Parade!
With all of the events happening this weekend in Big Bear Lake, you will need to take some breaks. Our cabins are within walking distance to Big Bear Village, so you can come back and relax, take in the scenery, and prepare for your next big adventure.
We hope you all have a wonderful week, and we will see you soon!
Gallery | This entry was posted in What to see and do and tagged Adventure, Big Bear CA, big bear lake, biking, cabins, Challenge, Conquer the Bear, cycling, events, family, music festival, Old Miners, summer, travel, vacation, What to Do. Bookmark the permalink.


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Community arts programs, also called participatory arts programs, include visual, media, and performing arts activities open to interested community members. Community-based organizations or art centers offer programs for community members to create artwork through collaboration and interactions with others. Programs can focus on building community, increasing awareness of the value of the arts, developing creativity, or addressing common issues within a community.
Community arts programs are a suggested strategy to increase social support and develop social capital throughout communities (NEA-Strategic plan 2014, Kelaher M, Dunt D, Berman N, Curry S, Joubert L, Johnson V. Evaluating the health impacts of participation in Australian community arts groups. Health Promotion International. 2013: Epub ahead of print.
Link to original source (journal subscription may be required for access)Kelaher 2013, Lewis 2013a, Jones PM. Developing social capital: A role for music education and community music in fostering civic engagement and intercultural understanding. International Journal of Community Music. 2010;3(2):291-302.
Link to original source (journal subscription may be required for access)Jones 2010, Stuckey 2010). Available evidence suggests community arts programs and creative activities can improve mental health for participants (Leckey J. The therapeutic effectiveness of creative activities on mental well-being: A systematic review of the literature. Journal of Psychiatric and Mental Health Nursing. 2011;18(6):501–9.
Link to original source (journal subscription may be required for access)Leckey 2011, Kelaher M, Dunt D, Berman N, Curry S, Joubert L, Johnson V. Evaluating the health impacts of participation in Australian community arts groups. Health Promotion International. 2013: Epub ahead of print.
Link to original source (journal subscription may be required for access)Kelaher 2013), including delinquent youth (Rapp-Paglicci L, Stewart C, Rowe W, Miller JM. Addressing the Hispanic delinquency and mental health relationship through cultural arts programming: A research note from the prodigy evaluation. Journal of Contemporary Criminal Justice. 2011;27(1):110-21.
Link to original source (journal subscription may be required for access)Rapp-Paglicci 2011). Such programs may also promote community involvement (Chung 2009). However, additional evidence is needed to confirm effects.
Community arts programs may improve health outcomes and increase community connections among older adults (Hallam S, Creech A, Varvarigou M, McQueen H. Perceived benefits of active engagement with making music in community settings. International Journal of Community Music. 2012;5(2):115-174.
Link to original source (journal subscription may be required for access)Hallam 2012, Phinney A, Moody EM, Small JA. The effect of a community-engaged arts program on older adults' well-being. Canadian Journal on Aging. 2014;33(3):336-345.
Link to original source (journal subscription may be required for access)Phinney 2014). A study of Porch Light, a Philadelphia-based mural art project, suggests that residents are more likely to perceive high levels of neighborhood cohesion and trust, and less likely to stigmatize individuals with mental illness in neighborhoods with participatory art projects (Tebes 2015).
Creative extracurricular activities such as music, dance, drama, and visual arts, frequently part of community arts programs, can improve self-confidence and self-esteem, and increase positive behaviors among participating children and adolescents (Bungay H, Vella-Burrows T. The effects of participating in creative activities on the health and well-being of children and young people: A rapid review of the literature. Perspectives in Public Health. 2013;133(1):44–52.
Link to original source (journal subscription may be required for access)Bungay 2013).
Several states have Arts Boards that promote art in the community programs (NASAA). Examples of community art programs include Active Arts at the Music Center in Los Angeles, CA (Active Arts), and Make Music New York (MMNY).
NEA - National Endowment for the Arts (NEA).
Animating Democracy - Animating Democracy. A program of Americans for the Arts: Fostering civic engagement through arts and culture.
Rapp-Paglicci 2011* - Rapp-Paglicci L, Stewart C, Rowe W, Miller JM. Addressing the Hispanic delinquency and mental health relationship through cultural arts programming: A research note from the prodigy evaluation. Journal of Contemporary Criminal Justice. 2011;27(1):110-21.
Jones 2010* - Jones PM. Developing social capital: A role for music education and community music in fostering civic engagement and intercultural understanding. International Journal of Community Music. 2010;3(2):291-302.
Stuckey 2010 - Stuckey HL, Nobel J. The connection between art, healing, and public health: A review of current literature. American Journal of Public Health. 2010;100(2):254-63.
Chung 2009 - Chung B, Jones L, Jones A, et al. Using community arts events to enhance collective efficacy and community engagement to address depression in an African American community. American Journal of Public Health. 2009;99(2):237-44.
Bungay 2013* - Bungay H, Vella-Burrows T. The effects of participating in creative activities on the health and well-being of children and young people: A rapid review of the literature. Perspectives in Public Health. 2013;133(1):44–52.
NEA-Strategic plan 2014 - National Endowment for the Arts (NEA). Art works for America: Strategic plan, FY 2014-2018. Washington, DC: National Endowment for the Arts (NEA); 2014.
Kelaher 2013* - Kelaher M, Dunt D, Berman N, Curry S, Joubert L, Johnson V. Evaluating the health impacts of participation in Australian community arts groups. Health Promotion International. 2013: Epub ahead of print.
Leckey 2011* - Leckey J. The therapeutic effectiveness of creative activities on mental well-being: A systematic review of the literature. Journal of Psychiatric and Mental Health Nursing. 2011;18(6):501–9.
Lewis 2013a - Lewis F. Participatory art-making and civic engagement. Animating Democracy; 2013. A working guide to the landscape of arts for change.
Hallam 2012* - Hallam S, Creech A, Varvarigou M, McQueen H. Perceived benefits of active engagement with making music in community settings. International Journal of Community Music. 2012;5(2):115-174.
Phinney 2014* - Phinney A, Moody EM, Small JA. The effect of a community-engaged arts program on older adults' well-being. Canadian Journal on Aging. 2014;33(3):336-345.
Tebes 2015 - Tebes JK, Matlin SL, Hunter B, et al. Porch Light Program: Final evaluation report. The Consultation Center at Yale. Yale School of Medicine; 2015.
NASAA - National Assembly of State Arts Agencies (NASAA). NASAA member directory.
Active Arts - Active Arts at the Art Center.
MMNY - Make Music New York (MMNY). A live, free musical celebration.