WO2016100866A1

WO2016100866A1 - Port closure device and methods of use

Info

Publication number: WO2016100866A1
Application number: PCT/US2015/066774
Authority: WO
Inventors: Sundaram Ravikumar; Guy Osborne
Original assignee: Beacon Surgical Instruments, Llc
Priority date: 2014-12-18
Filing date: 2015-12-18
Publication date: 2016-06-23

Abstract

The invention is directed to a port closure device including a mesh implant, supports for the mesh implant, and a suture to close the incision point above the mesh implant.

Description

PORT CLOSURE DEVICE AND METHODS OF USE CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

[0001] This application claims priority of a provisional application serial number

62/094,049 filed December 18, 2014 incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

[0002] The present invention relates to a port closure device, a kit containing the device, and method of use of the device.

BACKGROUND OF THE INVENTION

[0003] The present invention relates to a port closure device. The port closure device may be used to close ports or incisions points within the body during or at the

conclusion of a surgical procedures, such as the umbilicus. The port closure device includes a mesh implant and the port closure device may be used in the reconstruction of soft tissue defects, such as a hernia. Such mesh implants are in particular used in the repair of defects in the abdominal wall, which may be a result from trauma, tumor resection, prolapse or hernia. Other uses are known for a mesh implant and may be employed with the inventive port closure device. [0004] Within the field of surgical repair of soft tissue defects, use is often made of a mesh implant made of a non-resorbable material that is inserted to cover the area of the tissue defect. The mesh implant is used in order to support the regenerating tissue (e.g. hernia defect) and works by mechanical closure of the defect and by inducing a strong scar fibrous tissue around the mesh implant. Such a mesh implant is most often made of various plastics, which are known to stay biostaWe and safe for a number of years after implantation. However, such mesh implants may crumple up and loose its tissue supporting function over time.

[0005] One such use of a mesh implant is during a hemia surgical procedure. A hernia is an abnormal protrusion of a peritoneal-lined sac through the musculoaponeurotic covering of the abdomen, the most common site for a hernia being the groin. A hernia is a weakness or tear in the abdominal muscles which allows fatty tissue or an organ such as the intestines to protrude through the weak area. This can cause a noticeable bulge under the skin, and the pressure of tissue pushing its way through the weakened area can be the source of significant pain and discomfort for the patient. Symptoms can feel worse when the individual stands for long periods, during urination or a bowel movement, or when lifting heavy objects. Types of hernia include, without limitation, inguinal hernia or a femoral hernia, hiatal hernia, umbilicial hernia and incisional hernia, the latter being a hernia that pushes through a past surgical incision or operation.

[0006] One suggested theory in the field is that some patients, due to collagen metabolic disorders, have a genetic predisposition for developing recurrent hernias. Recurrent hernias are a common problem in hernia surgery. Even the best reports indicate from 1% to 4% recurrent hernias after primary surgery, and some authors report figures up to 20%. These figures are much lower when a non-absorbable mesh is utilized in the method of repair.

[0007] Older types of surgical repair of a hernia were through traditional tension repair wherein the surgeon made an incision in the abdomen over the hernia site, pushed any protruding tissue back into correct position within the abdominal cavity, and then stitched the hernia closed. A tension repair is used currently in some instances for children or if the hernia is extremely small in an adult patient. This technique however has several disadvantages. First, the level of discomfort following a tension repair is greater, and the recovery period is longer (about 4-6 weeks) than with a tension-free repair. In addition, there is an approximately 10-15 percent chance that the hernia will recur or happen again.

[0008] For cases dealing with large or recurrent hernias the surgeon may employ surgical repair or herniorrhaphy making use of an inert, non-resorbable mesh implant, as described above and herein. The mesh implant is inserted within the body cavity through a trocar, typically at the umbilicus or other incision port or point, and various surgical instruments are used (within he same large port or through additional incision points or ports within the fascia and body cavity) to place the mesh implant over and covering the area of the abdominal wall defect without sewing together the surrounding muscles of the target tissue location. This can be done under local or general anesthesia using a laparoscope or an open incision technique. The mesh implant is typically either sutured into the abdominal wall or fastening using a series of surgical staples or tacks. Many problems occur in such surgical procedures including the space needed to facilitate placement of the mesh implant, use of numerous sutures and staples, as well as the need to close the incision port or area. [0009] Among the laparoscopic techniques used in such conventional surgical procedures are the trans-abdominal pre-peritoneal (TAPP) technique and the totally extra-peritoneal (TEP) technique. With the TAPP technique, the pre-peritoneal space is accessed from the abdominal cavity, whereupon the mesh implant is placed between the peritoneum and the transversalis fascia. With the TEP technique, the mesh implant is again placed in the retroperitoneal space, but the space is accessed without violating the abdominal cavity. An open and minimal invasive technique is the Lichtenstein hernia repair technique, in which the upper edge of the mesh implant is attached to the outer side of the internal oblique and the lower edge of the mesh implant is attached to the aponeurotic tissue covering the pubis.

[0010] Another open minimal invasive technique is the mesh-plug technique comprising attaching a mesh implant, as described above in reference to the Lichtenstein technique, but also inserting a plug pushing the peritoneum in a direction towards the abdominal cavity.

[0011] In an open peritoneal technique, a small 1.5-2 inch incision is made near the hernia bulge. The hernia is then identified and pushed back into the abdomen. The space between the abdominal wall and the peritoneum is freed up. A mesh implant is then placed into this opening so that it covers the hernia, as well as other potential hernia sites. The mesh implant is then sutured into the site and in a separate step the fascia of the patient is then closed with sutures and glue. In an alternate surgical procedure of laparoscopy the surgeon inserts a laparoscope, a thin instrument consisting of a lighted tube with magnifying lenses, through an incision in the abdomen, typically at the umbilicus and can be between about 5 mm to about 30 mm in diameter. Carbon dioxide gas is placed into the abdominal cavity to create a working space. The laparoscope enables the surgeon to examine the hernia and accurately place a mesh plant on the inside of the abdominal wall, not outside as with traditional mesh repair. Through two other small incisions or ports in other locations on the fascia, special operating instruments are used to open up the space between the peritoneum and the abdominal wall, large enough to permit a mesh implant to be placed to cover the hernia hole and the other potential weak areas. The peritoneum is sewn back together again with sutures to keep the mesh implant in place, or surgical staples or tacks may be used to connect the mesh implant. The carbon dioxide gas is removed and the multiple incision points or ports in the abdomen and fascia are closed carefully so that they do not become hernias overtime. Lastly, a plug and patch repair procedures starts with an incision point or port made over the inguinal hernia. Once the herniated tissue has been pushed back in, then an umbrella shaped mesh implant plug is placed into the hole and the edges of the umbrella shaped mesh are sutured to the edges of the hole or connected via staples, tacks or the like. Then a second additional flat piece of mesh is placed between two layers of the abdominal wall to provide a more broad-based reinforcement of the hernia repair. This surgical procedure requires two layers of mesh implants over the target area where the hernia is located and increases surgical time and possibility of complications at the surgical site. Current complications from the various known surgical procedures include recurrence as discussed above and other side effects and complications such as injury to the bowl during surgery, swelling and pain in the scrotum or groin after surgery, development of a painful testicle, an infection of the mesh implant requiring removal in a second surgical procedure, and in general a prolonged recovery.

[0012] The mesh implant, also referred to as a patch or plug, inserted with any of the above described techniques, is used in order to support the regenerating tissue with minimal tension. It works by mechanical closure of the defect in the abdominal wall and by inducing a strong scar tissue around the mesh implant fibers. The commercially available hernia mesh implants are often made of various, inert, non-resorbable polymeric materials, typically polypropylene, and suffers from the same disadvantages, as described above in connection with mesh implants used for reconstruction of soft tissue defects in general. However, implantation of large pieces of mesh implants in the abdominal wall cavity also leads to considerable restriction thereof. Further, the non- physiological stretching capability of the mesh implants contrast with the highly elastic abdominal wall and can give rise to shearing forces.

[0013] Further problems have developed with conventional mesh implants and the suturing or stapling of such mesh implants to the abdominal wall, such as the common plastic "memory recoil ring" bordering the mesh implant may fracture, causing bowel perforations or abnormal connections between the intestines and other organs known as fistulae. This damage not only causes severe pain but can also lead to additional medical complications and death. In addition, while the mesh implants are typically made of various plastics which are known to stay biostable and safe at least for the usual follow-up time of 5 to 10 years after implantation, the possibility of degradation, cracking and breakage within the body remains and certain mesh implants have been the subject of recalls in the United States. On the other hand, permanent surgical implants (metals, silicone, etc.) have been shown to cause side effects in many patients because of corrosion, wearing, migration, chronic inflammation and risk of infection. When the foreign material is placed near sensitive organs, the risks of these side effects can be severe to the patient's well-being. In the case of hernia surgery, the plastic mesh will always become situated into close contact with the sensitive intra-abdominal organs.

[0014] The progress within hernia repair mesh implant development, as well as in the development of mesh implants for the use of reconstruction of soft tissue defects in general, has been towards mesh implants with less mass in order to minimize foreign body reactions, and larger pore sizes, which on one hand reduce the mass of the mesh implant and on the other facilitate ingrowth of tissue. However, problems remain with such conventional mesh implants. [0015] Further problems with the various surgical procedures employing mesh implants are the fasteners in the form of staples, tacks or the like used for implanting the mesh implants to the patient's tissue or organs. While other tissue fastening devices have been proposed which differ from staples per se, such other fasteners may have a plurality of components and other associated problems therein. For example, such fastening devices require access to both sides of a tissue site since they typically include an upper section having a crown and legs and a lower receiver, wherein the lower receiver engages and locks the legs of the upper section, making the surgical procedure longer and more complicated, resulting in potential complications to the patient.

[0016] Thus, there is a need to provide improved fastening devices for use with a mesh implant which are relatively easier to apply and relatively difficult to remove. In particular, there is a need for surgical fastening devices which do not require a second separate piece or receiver to lock, form or maintain the fastener in place in tissue, which can be applied and secured from one side of a tissue site, most desirably in an endoscopic or open surgical procedure, and which overcome the disadvantages associated with conventional surgical staples or tacks or sutures.

[0017] Further needs in the art include a mesh implant and port closure device which stabilizes the area of surgery, deploys or activates the mesh implant, connects the deployed mesh implant to the tissue via conventional or inventive fasteners, and closes the incision point or port, with one device. The inventive port closure device may be used for a variety of surgical procedures, such as a hernia, but may also be used solely to close a surgical incision port or point, such as at the umbilicus or any incision point on a patient's fascia or within a body cavity or elsewhere. The inventive device may decrease surgical time, decrease the number of surgical instrument within the incision point, decrease the potential complications and decrease pain for the patent.

[0018] Accordingly, there remains a need in the art for the inventive port closure device including a mesh implant, its method of use and a kit containing the inventive device. The present invention provides a solution for these needs and other needs. [0019] The present invention has been made to solve the above problems occurring in the prior art and other needs in regard to surgical instruments and methods of treatment.

SUMMARY OF THE INVENTION

[0020] In one aspect, a surgical instrument and assembly for laparoscopic procedures is provided, which is adapted and configured to include a port closure device, a mesh implant, supports for the mesh implant, and a suture configured to close the incision point above the mesh implant once implanted during use.

[0021] In yet another aspect, a method for laparoscopic procedures is provided including use of a surgical instalment for laparoscopic procedures, which is adapted and configured to include a port closure device, a mesh implant, supports for the mesh implant, and a suture to close the incision point above the mesh implant.

[0022] In another aspect, a kit for laparoscopic procedures is provided including a device which is adapted and configured to include a port closure device, a mesh implant, supports for the mesh implant, and a suture to close the incision point above the mesh implant.

DESCRIPTION OF THE DRAWINGS

[0023] The above and other advantages of the present invention will become readily apparent with reference to the following detailed description when considered in conjunction with the accompanying drawings which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the devices and related methods of the invention. Together with the description, the drawings serve to explain the principles of the invention, wherein: [0024] FIGURE 1 is a perspective view illustrating one embodiment of the inventive port closure device with the mesh implant retracted within the housing.

[0025] FIGURE 2 is a perspective of a cut-away view illustrating one embodiment of the inventive port closure device with the mesh implant retracted within the housing and showing the suture and proximal end of the supports exposed. [0026] FIGURE 3 is a further perspective of a cut-away view of FIGURE 2 further including an optional stabilize device on the housing of the inventive port closure device.

[0027] FIGURE 4 is a perspective view of a one embodiment of the inventive port closure device with the mesh implant partially activated and extending from the housing. [0028] FIGURE 5 is a bottom view of one embodiment of the inventive port closure device showing the partially activated mesh implant.

[0029] FIGURE 6 is a close up view of a distal end of one embodiment of the partially activated mesh implant within the inventive port closure device wherein the fastener is a hook. [0030] FIGURE 7 is a top view of one embodiment of the fully activated mesh implant and suture in the inventive port closure device.

[0031] FIGURE 8 is a side cut-away view of one embodiment of the port closure device showing the distal end of the housing and the internal folded, inactivated and non- deployed mesh implant. [0032] FIGURE 9 is a side cut-away view of another embodiment of the port closure device showing the distal end of the housing and the internal folded, inactivated and non-deployed mesh implant and including a stabilization device.

[0033] FIGURE 10 is a side view of a cut-away exploded view of one embodiment of an activated port closure device with the mesh implant partially activated and deployed out of the housing.

[0034] FIGURE 11 is a side view of a one embodiment of an activated port closure device with the mesh implant partially activated out of the housing.

[0035] FIGURE 12 is a perspective view of another embodiment of the inventive port closure device with the mesh implant partially activated and including an optional stabilizing device on the housing. [0036] FIGURE 13 is a side view of another embodiment of the inventive port closure device with the mesh implant fully activated and including an optional stabilizing device on the housing.

[0037] FIGURE 14 is a side view of one embodiment of the inventive port closure device in use within a patient's fascia and with the mesh implant fully activated with the supports being retracted from the mesh implant and up partially within the housing, and showing the suture.

[0038] FIGURE 15 is a perspective view of one embodiment of the present inventive port closure device in use within a patient's fascia showing the mesh implant fully activated, the housing and supports having been retracted, and showing the suture.

[0039] FIGURE 16 is a side view of one embodiment of the inventive port closure device in use within a patient's fascia and with the mesh implant fully activated and attached to the target tissue under the patient's fascia, and showing the suture.

[0040] FIGURE 17 is a perspective view of another embodiment of the inventive port closure device including a pistol grip activation means and the mesh implant folded and stored within the housing in a non-activated state.

[0041] FIGURES 18A is a perspective view of one embodiment of an inventive fastener to be used with the inventive port closure device.

[0042] FIGURE 18B is a side view of the embodiment of FIGURE 18A of an inventive fastener to be used with the inventive port closure device.

DETAILED DESCRIPTION OF THE INVENTION

[0043] Reference will now be made in detail to the present invention, examples of which are illustrated in the accompanying drawings.

[0044] In accordance with one aspect of the invention, a port closure device is provided including an unactuated and non-deployed mesh implant and the device having the capacity to close the port or incision point through which the inventive device is inserted into the fascia, a body cavity or other location within a patient. In accordance with one aspect, the inventive port closure device has a housing including a suture thread within and at the distal end of the housing a folded and non-deployed mesh implant. The mesh implant is configured similar to an umbrella including a plurality of supports. The support may be attached to a plurality of fasteners on the outer edge of the mesh implant and the support may be retracted at a proximal end of the housing upon connecting of the mesh implant via the fasteners to the tissue within the body cavity of the patient. Upon connection of the deployed mesh implant and retraction of the supports and the housing, the suture which is connected to the mesh implant (in one embodiment in the center of the mesh implant) is used to close the incision port. The device may include a deploying mechanism such as a push rod, pull rod, loop grip mechanism, thumb grip mechanism, pistol grip mechanism or other mechanism for the surgeon to deploy the mesh implant.

[0045] It should be noted that although the devices of the present invention are advantageous for various laparoscopic surgeries, including closing a umbilicus opening or for hernia procedures, they can advantageously be applied to close other incision ports or to deploy the mesh implant to other parts of the body, for example, within a uterine wall or the like.

[0046] The inventive port closure device advantageously provides one device through which a mesh implant may be inserted into the body cavity of a patient, deploy the mesh implant as a certain chosen location within a body, fasten the mesh implant (in one embodiment with the inventive fasteners), and close or suture the incision port, all through one device. The inventive closure device thus may reduce surgical time, surgical costs, number of ports or incisions needed for the surgical procedure, as well as potentially reduce complications and pain for the patient. [0047] For the purposes of explanation and illustration, and not limitation, in accordance with the invention, an exemplary embodiment of a port closure device in an unactuated position is illustrated in FIGURES 1 through 3 and in an actuated position is illustrated in FIGURES 2 and 4 through 16. In accordance with these examples, the port closure device 100 includes a housing 110 having a diameter in a range of about 1 mm to about 50 mm, with a length of about 10 mm to about 1000 mm including in a range of about 20 mm to about 400 mm of length. The length of the housing 110 may be dependent on the target location for the mesh implant to be fastened within the body. The housing 110 may be a tube or cannula. The housing 110 may be hollow in which to hold the folded, unactuated and non-deployed mesh implant (300, not shown in FIGURE 1 ) at the distal end of the housing 110 and at the proximal end a deployment mechanism 190 for the mesh implant. In one embodiment the diameter of the housing 110 is about 7.5 mm, with other embodiments including but not limited to a housing 110 diameter of about 2 mm. 3 mm, 5 mm, 10 mm, 12.5 mm, 15 mm, 16 mm, 20 mm, 25 mm, 30 mm or larger. The diameter of me housing 110 may be related to the dimensions of the folded unactuated mesh implant (300) as within the inner diameter of the hollow housing 110. For instance, a pediatric patient may require a smaller diameter deployed and actuated mesh implant 300 such that the diameter of the housing 110 may be about 3 mm or about 5 mm. [0048] Housing 110 may be comprised of any material compatible to the human body as the distal end of the housing 110 will be placed within the body cavity for deployment of the mesh implant 300. Such materials for the housing 110 include plastics or metals. If a metal, the housing 110 may be comprised of stainless steel and may further be coated with a shrink wrap plastic such as shrinkable polyethylene fiberglass, or polyvinyl chloride of a grade suitable for use in surgical procedures. The housing 110 may be comprised of many known polymers such as polycarbonates or ABS. For cost effectiveness, the housing 110 may be comprised of any plastic capable of sterilization according to regulatory agencies for medical devices.

[0049] The dimensions of the housing 110 may be a diameter in the range of about 1 mm to about 50 mm, preferably between about 3 mm to about 25 mm. The dimensions of the housing 110 may also be such that the diameter is slightly larger or smaller than the maximum diameter of the unfolded, deployed, actuated and open mesh implant 300.

[0050] The housing 10 may be hollow and thus includes a channel which houses the folded non-deployed unactuated mesh implant 300 which mesh implant 300 is connected to the deployment mechanism. The deployment mechanism may be a push rod 190 as shown in FIGURE 1 or a pistol grip deployment mechanism 400 as shown in FIGURE 17 or may be any known conventional deployment mechanism. In an unactuated position, the push rod 190 has a distal end partially housed within the housing and a proximal end extending out of the proximal end of the housing 110. To deploy the folded unactuated mesh implant 300 the rod 190 is pushed in a downward direction toward the distal end of the housing 110 such that the rod 190 resides fully within the housing 110 or partially resides within and with a portion of the proximal end of the rod 190 extending out of the housing 110. In the actuated position the mesh implant 300 is moved from a stowed position within the distal end of the housing 110 to a deployed position by pushing the mesh implant 300 out of the housing 110. The rod 190 may be connected to a rod grip which the surgeon may use in actuating the inventive device 100, such as a ring grip, finger grip, thumb grip, pistol grip, or other known grips. [0051] In another embodiment of the present invention as shown in FIGURE 17 the port closure device includes a pistol grip deployment mechanism 400. The pistol grip deployment mechanism 400 includes a handle 410 with internal mechanisms to deploy the folded unactuated mesh implant 300. The handle 410 includes a trigger 430 and a proximal housing member 420. Other deployment mechanisms may be employed. [0052] The distal end of the housing includes a cap 120. The cap 120 has a distal end 130 which may be tapered and may be solid or may include optionally a plurality of indentations 140 to facilitate the deployment of the supports 160 connected to the mesh implant 300. For instance and by way of example only, if the port closure device 100 includes six supports 160 connected to the mesh implant 300 then there may be six corresponding indentations 140 within the distal end 130 of the cap 120. The cap 120 may be of any material compatible to the human body as it will be placed within the body cavity for deployment of the mesh implant 300. Such materials for the cap 120 include plastics or metals. If a metal, the cap 120 may be comprised of stainless steel and may further be coated with a shrink wrap plastic such as shrinkable polyethylene fiberglass, or polyvinyl chloride of a grade suitable for use in surgical procedures. The cap 120 may be comprised of many known polymers such as polycarbonates or ABS. For cost effectiveness, the cap 120 may be comprised of any plastic capable of sterilization according to regulatory agencies for medical devices.

[0053] The mesh implant 300 is folded within the distal end of the housing 110. The mesh implant 300 may be of any shape such as a circle, oval, sphere, rectangle, square, triangle, or the like. The mesh implant 300 may be of a size ranging from about less than 1 mm to about 100 mm on each side if non-spherical depending on the shape of the mesh implant 300. The mesh implant 300 may have a diameter of about less than 1 mm to about 100 mm. The shape, size, area and diameter of the mesh implant 300 may be dependent on the target tissue to be connected to the mesh implant 300 such as closing a port having a diameter of about 10 mm or connecting to a hernia location with an area of about 1000 mm².

[0054] The mesh implant 300 may be comprised of any material compatible to the human body as It will be implanted within the body cavity. Such materials for the mesh implant 300 include plastics or metals. The mesh implant 300 may be comprised of many known polymers such as polycarbonates or ABS. In one embodiment of the present invention the mesh implant 300 is comprised of a surgical grade polyester or polypropylene mesh. Optionally, the mesh implant 300 may be coated or laminated on the distal side with a non-adhesion material such as without limitation a perforated LDPE film to reduce the potential for bowel adhesion or a progressively biodegradable material. Further, the mesh implant 300 may be a woven or knitted structure or can have a non-woven, for instance electro-spun, structure, wherein the (electro-spun) non- woven structure can further be furnished with man made through and through holes. When two or more materials are incorporated with each other, fibres of said materials, respectively, can be jointly woven, knitted or non-woven into the same suitable structure. Also various materials can be spun into fibres which are braided, twisted into a multifilament produced from two or more materials, which multifilament is woven, knitted or non-woven into said suitable structure. It is understood that any combination of fibers in the form of monofilament, filament bundles, multifilament or braided or twisted multifilament can be combined into the desired structure. [0055] The mesh implant 300 may further comprise bioactive or therapeutic substances including without limitation those naturally present in humans or of foreign origin. These substances include, but are not limited to, proteins, polypeptides, peptides, nucleic acids, carbohydrates, lipids or any combinations thereof. Especially considered are growth factors, such as PDGF, TGF or FGF, or components of the naturally occurring extracellular matrix, including cytokines, fibronectins, collagens, and proteoglycans such as but not limited to hyaluronic acid. Therapeutic substances that are considered include, but are not limited to, antibiotic drugs and pain relieving substances. Bioactive or therapeutic substances of human or foreign origin can be coated onto the mesh implant 300 or entrapped within the porous structure of the implant or incorporated through covalent or other chemical or physical bonding, in an active state or as precursors to be activated upon any physical or chemical stimuli or modification.

[0056] In one embodiment of the present invention the mesh implant 300 is folded within the distal end of the housing 110 in a shape similar to that of a folded umbrella. In this embodiment of the present invention the mesh implant 300 includes a plurality of supports 160 which on a distal end of each support 160 for example only, forms tines or barbs such as those on the underside of an umbrella. The supports 160 may number between 2 to 10 or more depending on the area of the tissue or organ to which the mesh implant 300 will be connected as well as the size of the mesh implant 300. In one embodiment of the present invention between about 4 to about 8 supports 160 are included to support the deployed mesh implant 300 in its actuated state as shown in FIGURES 4-7 and 10-16. The supports 160 may be comprised any material

compatible to the human body as it will be placed within the body cavity upon

deployment of the mesh implant 300. Such materials for the supports 160 include plastics or metals. If a metal, the supports 160 may be comprised of stainless steel or titanium and may further optionally be coated with a shrink wrap plastic such as shrinkable polyethylene fiberglass, or polyvinyl chloride of a grade suitable for use in surgical procedures. The supports 160 may be comprised of many known polymers such as polycarbonates or ABS. For cost effectiveness, the support 160 may be comprised of any plastic capable of sterilization according to regulatory agencies for medical devices. [0057] The distal end of each of the supports 160 is connected to the outer edge of the mesh implant 300 via a connecting means. The connecting means may be a staple, crimp, nut, bolt, screw, solder, tack, suture, glue or any known fastener. The

connecting means may be biodegradable or non-biodegradable depending on the location within the body and proposed use for the mesh implant. The connecting means may be temporary in that the supports 160 will be removed from the mesh implant, either after implantation of the mesh implant 300 on the target tissue or at some later time during the same surgery or even a subsequent surgery after a period of hours or days or weeks or even later, or may be permanently connected to the mesh implant 300. As shown in FIGURES 4-6, in one embodiment of the present invention a crimp 305 connects the supports 160 to the mesh implant 300. In another embodiment of the present invention as shown in FIGURES 8-11 an inventive fastener 310 connects the supports 160 to the mesh implant 300 and can also be used to fasten the mesh implant 300 to the target tissue. In yet another embodiment of the present invention the distal end of the supports 160 may be each alternately fastened to the mesh implant 300 in that every other support 160, for instance every even support 160, is connected to the mesh implant 300 whereas the other odd supports 160 are not connected at the distal end to the mesh implant 300.

[0058] In one embodiment of the present invention the distal end of the supports 160 are configured in a hook shape so as to fasten the mesh implant 300 to the target tissue, as shown in FIGURES 6 and 7, and thus remain permanently connected to the mesh implant 300 and remain within the patient. In another embodiment of the present invention, the inventive fasteners connect the support 160 temporarily to the mesh implant 300 but upon sufficient pulling force the supports 160 are disconnected from the mesh implant 300 and retracted out of the housing (if not already retracted and removed itself) and the body cavity. The inventive fasteners 310 in such an

embodiment remain and are used to fasten the mesh implant 300 to the target tissue. The other connecting means to fasten the mesh implant 300 to the target tissue may also be employed such as staples, tacks, sutures, glue, and other conventional fasteners or fasteners as later developed in the art. [0059] In yet another embodiment of the present invention the mesh implant 300 includes removable supports 160 which are not fastened to the outer edge of the mesh implant 300 but are only connected by looping through the suture 150 within the center of the mesh implant 300. In yet a further embodiment the distal end of the supports 160 may be temporarily fastened to the outer edge of the mesh implant 300 such that upon deployment and opening of the folded mesh implant 300 the support 160 assist to support the shape of the mesh implant 300 but such fastening means is detached from the mesh implant 300 with minimum force exerted so that the mesh implant 300 and suture 150 remain without any fasteners. The mesh implant in such an embodiment may include a plurality of apertures along the outer edge of the mesh implant for insertion of separate fasteners to attach and implant the mesh implant 300 to the target tissue. In such an embodiment the fasteners may include without limitation tacks, staples, screws, nuts, bolts, sutures, glue and the like or combinations thereof.

[0060] The inventive port closure device 100 may further include a connecting means 340 which may connect to the supports 160 at the point where such supports 340 pass over the center of the mesh implant 300. The connecting means 340 may function to tie the plurality of supports 160 together at one point so each support is not moving apart from the other prior to bending in a configuration along the surface of the folded or deployed mesh implant 300. The connecting means 340 may be comprised of any material compatible to the human body as it will be placed within the body cavity for deployment of the mesh implant 300. Such materials for the connecting means 340 include plastics or metals. If a metal, connecting means 340 may be comprised of stainless steel and may further be coated with a shrink wrap plastic such as shrinkable polyethylene fiberglass, or polyvinyl chloride of a grade suitable for use in surgical procedures. The connecting means 340 may be comprised of many known polymers such as polycarbonates or ABS. For cost effectiveness, the connecting means 340 may be comprised of any plastic capable of sterilization according to regulatory agencies for medical devices. In one embodiment of the present invention the connecting means 340 is a plastic or metal rivet, crimp, open tie such as a circle, or washer or the like or combinations thereof. In another embodiment the connecting means is a small cap connected to the distal end of each support 160 and having a hub on the other side of the connection location. In another embodiment the connecting means is permanently connected to the mash implant 300 such as a rivet 330 as shown in FIGURES 4, 5, and 7.

[0061] The inventive port closure device 100 further includes a pre-loaded suture 150 to close the incision point above the fastened mesh implant 300. The suture 150 may be comprised of silk, vicryl, davdelk, polypropylene, polymers or any other conventional thread or tying material. The suture 150 is loaded into the housing 110 so that it starts on one side, is housed within the hollow channel of the housing 110, is connected to the center of the mesh implant 300 typically through two apertures located near the center of the mesh implant 300 though other locations on the mesh implant 300 and more than two apertures may be employed, and the other end is housed on the other side of the housing 110 as shown in FIGURES 1, 3. 8-15. The suture 150 extends out of the proximal end of the housing 110 so that upon deployment and fastening of the mesh implant 300 to the target tissue and retraction and removal of the supports 160 the surgeon can suture the port or incision point closed with the pre-loaded suture 150.

[0062] The inventive port closure device 100 may optionally include a stabilization device 200. The stabilization device 200 has a housing 210 which is vertically movable on the outer surface of the housing 110 during surgery. The stabilization device 200 may be lowered vertically so as to rest on the outer fascia of the patient at the incision point or port The stabilization device 200 may be comprised of any material, preferably compatible to the human body though it will not reside within the body cavity but rest on the outer fascia. Preferred materials are plastics or metals. The stabilization device 200 has a wider bottom surface 220 for stabilization purposes and has in one embodiment two grips 230a, 230b to facilitate the downward and upward movement on the housing 110. The grips 230a, 230b may be comprised of plastics or metals. The grips 230a, 230b are connected to the stabilization device 200 via a connecting means 240 such as a pin, screw, bolt, nut, crimp, solder, or any connecting means. If the stabilization device 200 is a metal it may be comprised of stainless steel and may further be coated with a shrink wrap plastic such as shrinkable polyethylene fiberglass, or polyvinyl chloride of a grade suitable for use in surgical procedures. The stabilization device 200 may be comprised of many known polymers such as polycarbonates or ABS. For cost effectiveness, the stabilization device 200 may be comprised of any plastic capable of sterilization according to regulatory agencies for medical devices.

[0063] A method of use of the inventive port closure device 100 includes the steps of inserting the port closure device 100 through an incision port or point in the fascia 500 of a patient. Optionally no other surgical instrument or trocar is within the incision point or port upon insertion of the inventive port closure device 100, though in one

embodiment of the inventive method the port closure device 100 may be inserted through a trocar with the trocar later removed prior to suturing of the incision port or point.

[0064] Next the distal end 130 and cap 120 of the housing 110 are placed below or near the target location of the tissue to which the non-deployed and unactuated mesh implant 300, which is housed and folded within the housing 110, will be fastened and implanted. If the surgeon is using the inventive port closure device 100 to close an incision port then the distal end and cap 120 of the housing 110 are inserted within the incision port or point in the fascia 500 a sufficient amount such that the mesh implant 300 may be deployed safely within the body or body cavity to be fastened to the tissue on each side of the incision port or point. The deployment mechanism, such as a push rod 190, is activated and the folded unactuated mesh implant 300 is deployed from within the interior of the housing 110, through the cap 120 (and optionally the distal end 130 and indentations 140 of the cap 120). This movement also pushes or extends the distal end of the supports 160 and the suture 150, both attached to the mesh implant 300 (at the center of the mesh implant 300 or one or more other locations on the mesh implant 300), out of the distal end of the housing 100. The mesh implant 300 in its partially deployed state or position resembles the shape of an umbrella in one embodiment of the invention as shown in FIGURE 10 through 13. The housing 110 may be retracted out of the body and fascia 500 at this time in the method, or may be retracted or removed upon attachment or fastening of the mesh implant 300 to the target tissue. As shown in FIGURE 14 the housing 110 has been removed from the fascia 500 and the deployed mesh implant 300 and the supports 160 and the suture 150 remain within the body. In one embodiment of the invention the distal ends of the supports 160 may include a hook 307 or other connecting means and are used to connect or fasten the mesh implant 300 to the target tissue.

[0065] The mesh implant 300 in its fully deployed state or position resembles the shape of a circle in one embodiment of the invention as shown in FIGURE 14. In another embodiment of the present invention wherein the supports 160 do not include fasteners (305 or 310) but rather the mesh implant 300 includes separate fasteners (not shown) the mesh implant 300 is then moved into a position for attachment or fastening to the target tissue, typically in an upward or side direction depending on the location of the incision port or point on the fascia 500. The supports 160 are then retracted and removed, such as by force or other mechanisms. As shown in FIGURE 15 the deployed mesh implant 300 and the fasteners 310 and the suture 150 remain in the body. As shown in FIGURE 16, the mesh implant 300 is then attached and fastened to the target tissue, whether it is a hernia or the sides of an incision port or other target location, via the fasteners 310.

[0066] In each embodiment of the present invention once the mesh implant 300 is sufficiently fastened to the target tissue the suture is then employed by the surgeon to close the incision port. The ends of the single suture 150 are outside of the fascia 500 with a portion of the suture 150 connected to, in one embodiment of the inventive port closure device 100, the center of the mesh implant 300. The surgeon then pulls the ends of the suture 150 with force and knots or otherwise closes the suture and thus closes the incision point or port. Thus no additional instruments may be needed to close the incision port or point. Additional sutures may be employed by the surgeon to close the incision point or port. [0067] A further inventive component of the present invention is an inventive fastener 310, shown in FIGURES 18A and 18B, which is configured so that a distal end of the support 160 is retained within an aperture 312 of a proximal end 314 of the fastener 310 but said distal end of the support 160 may be detached and released from the aperture 312 upon sufficient force such that the support 160 may be removed from the mesh implant and the fascia 500 through the incision port, or optionally through the housing 110 if not previously removed. The distal end 316 of the fastener 310 extends from the mesh implant 300 and is configured to connect the mesh implant 300 to the target tissue. Many shapes and forms of the inventive fastener are possible including without limitation the one depicted in the figures.

[0068] Another aspect of the present invention is a surgical kit which includes the port closure device 100. The kit is stored in a sterile sealed package. The kit may include a trocar, a scissors device, a grasper device, a specimen retrieval device and the port closure device 100. The kit may optionally include a cauterizing device such as a bi- polar device. Other optional devices may be included. In one embodiment of the inventive kit all components are single use only and disposable. In another embodiment of the inventive kit some components are single use and disposable while others are reusable (typically after sterilization). In yet another embodiment of the inventive kit the components are reusable (typically after sterilization) except that the bag would be single use only and disposable.

[0069] Advantages of the inventive port closure device 100 include the configuration such that it is easier to close an incision port or point on the fascia of a patient.

Accordingly the incision location is smaller and may cause less surgical damage to the fascia, reduce the total operation time required for the procedure and reduce possible complications. As only one surgical instrument and/or device is needed to close the incision point or port the surgical process for closing an incision port or point can be simplified by using the inventive port closure device 100 and the time and cost for the surgery can be reduced.

[0070] Further, the configuration of the inventive extractor device 100 enables it to, compared to conventional surgical instruments and devices, better stabilize the area of surgery, deploy or activate the mesh implant, connect the deployed mesh implant to the tissue via conventional or inventive fasteners, and close the incision point or port, all with one device. The inventive port closure device may be used for a variety of surgical procedures, such as a hernia, but may also be used solely to close a surgical incision port or point, such as at the umbilicus or any incision point on a patient's fascia or within a body cavity or elsewhere. The inventive device and inventive methods may decrease surgical time, decrease the number of surgical instrument within the incision point, decrease the potential complications and decrease pain for the patient. Overall, the port closure device 100 may reduce complications, surgical processes, time and cost.

[0071] Many possible combinations could be within the port closure device, the methods of use, the method of treatment and the kit or system of the present invention.

[0072] The inventive fastener further provides an improved manner to fasten a mesh implant to a target tissue or location within or outside of a body cavity or other location for a patient (human or animal) in an easier way.

[0073] Although the exemplary embodiments of the present invention have been described, it is understood that the present invention should not be limited to these exemplary embodiments but various changes and modifications can be made by one ordinary skilled in the art within the spirit and scope of the present invention as hereinafter claimed.

[0074] The invention has been described in terms of embodiments thereof, but is more broadly applicable as will be understood by those skilled in the art. The scope of the invention is only limited by the following claims.

[0074] These objects are achieved by the present invention according to the preambles of the independent claims and provided with the features according to the characterizing portions of the independent claims. Preferred embodiments of the present invention are set forth in the dependent claims.

Claims

CLAIMS WHAT IS CLAIMED IS:

1. A surgical instrument and assembly for laparoscopic procedures; comprising: a port closure device having a hollow housing; a mesh implant having a fokJable mesh material; a plurality of supports; a hollow cap to which is held the plurality of supports, the hollow cap being at a distal end of the hollow housing and having at least an opposite pair of grooves; a plurality of fasteners attached to the plurality of supports in a manner that fastens the plurality of supports to the mesh material; and at least one suture thread that extends through the hollow housing to the cap; wherein the mesh implant and said housing are configured and arranged so that the mesh implant moves between a stowed condition within the housing and a deployed condition outside the housing, the plurality of supports being configured and arranged to move between a retracted position that folds the mesh material to enable placement of the mesh implant in the stowed condition and an extended position outside the housing that unfolds the mesh material to enable placement of the mesh implant in the deployed condition, the suture thread extending across the opposite pairs of grooves with the mesh implant in the stowed condition and extending across a center of the mesh with the mesh implant in the deployed position.

2. The surgical instrument and assembly of claim 1 , further comprising: a stabilization device movable along an exterior of the hollow housing between multiple relative positions, the stabilization means has grips that are movable between a grasping condition that grasps the hollow housing is a secure manner to prevent relative movement of the stabilization device on the hollow housing and a released condition that releases the grips from the grasping condition to permit relative movement of the stabilization device on the hollow housing.

3. The surgical instrument and assembly of claim 1 , wherein the stabilization device has opposite ends with one of the opposite ends being wider than a remaining one of the opposite ends, a wider one of the opposite ends being arranged closer to the cap than is the remaining one of the opposite ends.

4. The surgical instrument and assembly of claim 1 , wherein the fasteners are hooks, the mesh material having crimps, the supports connecting to the mesh material by engagement of the hooks and crimps with each other.

5. The surgical instrument and assembly of claim 1 , wherein the fasteners have one horizontal surface attached to the mesh implant and a connecting means extending from the opposite side of the fastener at an angle of between about 10 degrees to about 90 degrees compared to the horizontal surface with the connecting means including an aperture, the supports connecting to the mesh material by engagement of the aperture within the fasteners.

6. The surgical instrument and assembly of claim 1 , further comprising: a deployment mechanism in operative connection with the mesh implant to deploy the mesh implant.

7. The surgical instrument and assembly of claim 6, wherein the deployment

mechanism is selected from the group consisting of a push rod, pull rod, thumb grip and a pistol grip deployment mechanism.

8. A method of assembling a surgical instrument for laparoscopic procedures;

comprising: providing components of a surgical instrument, the components including: a port closure device having a hollow housing; a mesh implant having a foldabte mesh material attached to a deployment mechanism; a plurality of supports; a hollow cap to which is held the plurality of supports, the hollow cap being at a distal end of the hollow housing and having at least an opposite pair of grooves; a plurality of fasteners attached to the plurality of supports in a manner that fastens the plurality of supports to the mesh material; and at least one suture thread that extends through the hollow housing to the cap; configuring and arranging the mesh implant and said housing so that the mesh implant moves between a stowed condition within the housing and a deployed condition outside the housing; configuring and arranging the plurality of supports to move between a retracted position that folds the mesh material to enable placement of the mesh implant in the stowed condition and an extended position outside the housing that unfolds the mesh material to enable placement of the mesh implant in the deployed condition; and extending the suture thread across the opposite pairs of grooves with the mesh implant in the stowed condition and across a center of the mesh with the mesh implant in the deployed position.

9. The method of claim 8, further comprising; moving a stabilization device along an exterior of the hollow housing between multiple relative positions; and moving grips of the stabilization means between a grasping condition that grasps the hollow housing is a secure manner to prevent relative movement of the stabilization device on the hollow housing and a released condition that releases the grips from the grasping condition to permit relative movement of the stabilization device on the hollow housing.

10. The method of claim 9, wherein the stabilization device has opposite ends with one of the opposite ends being wider than a remaining one of the opposite ends, further comprising: arranging a wider one of the opposite ends of the stabilization device closer to the cap than is the remaining one of the opposite ends..

11. The method of claim 8, wherein the fasteners are hooks, further comprising: attaching the supports to the mesh material by engaging the hooks and the crimps with each other.

12. The method of claim 8, wherein the fasteners have one horizontal surface attached to the mesh implant and a connecting means extending from the opposite side of the fastener at an angle of between about 10 degrees to about 90 degrees compared to the horizontal surface with the connecting means including an aperture, further comprising: attaching the supports to the mesh material by engagement of the aperture within the fasteners.

13. The method of claim 8, further comprising: operating a deployment mechanism in operative connection with the mesh implant to deploy the mesh implant.

14. The method of claim 13, wherein the deployment mechanism is selected from the group consisting of a push rod, pull rod. thumb grip and a pistol grip deployment mechanism.