Patent Publication Number: US-9888952-B2

Title: Surgical tack delivery system, method and kit

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional application of U.S. patent application Ser. No. 12/983,544, filed Jan. 3, 2011, now allowed. This application is incorporated herein by reference, in its entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure generally relates to medical devices for securing and spacing, and more particularly to a surgical tack delivery system, method and kit for securing membranes or maintaining spaces in dental and orthopedic applications. 
     BACKGROUND 
     Surgical tacks can be used in dental and orthopedic applications for securing membranes, maintaining spaces, etc. Traditional delivery methods rely on mallet delivery while the physician holds a surgical tack in place with a forceps. The process of holding the surgical tack in place and providing a driving force thereto with the mallet results in an application of unpredictable force and accuracy. The process requires both hands of the installer to install the surgical tack. 
     SUMMARY OF THE INVENTION 
     Accordingly, a surgical tack delivery system, method and kit are provided. 
     In one embodiment, in accordance with the principles of the present disclosure, a system for delivering surgical tack is provided. The system includes a driver, comprising: a shaft having a slot and a channel; and a handle slidably connected to said shaft and having a driving mechanism, said driving mechanism having a driving pin for providing a downward force through said shaft; and a tack cartridge having a plurality of tacks and adapted to be received in said slot and further adapted to feed said tacks between said driving mechanism and said channel. 
     In another embodiment, in accordance with the principles of the present disclosure, a method for delivering a surgical tack is provided. The method includes providing a driver containing a tack cartridge having a plurality of tacks contained therein, said driver having a driving mechanism and a shaft, said shaft having a channel at a distal end thereof, wherein when said tack cartridge is inserted into said slot a first tack of said plurality of tacks is aligned with said driving mechanism and said channel; placing a distal end of the channel at a location of a tissue at which a first tack is to be inserted; providing pressure on the handle in the direction of the distal end of the channel, said pressure providing a driving force for said driving mechanism, said driving force being transferred to said first tack to drive said first tack into said piece of work; and moving a second tack into alignment with said driving mechanism and said shaft. 
     In yet a further embodiment, in accordance with the principles of the present disclosure, a kit for delivering a surgical tack is provided. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which: 
         FIG. 1  is a cross section view of a tack delivery system in its normal rest condition in accordance with the principles of the present disclosure; 
         FIG. 2  is a cross section view of a tack delivery system in its pressure condition in accordance with the principles of the present disclosure; 
         FIG. 3  is a cross section view of a tack delivery system in its tack insertion condition in accordance with the principles of the present disclosure; 
         FIG. 4  is a cross sectional diagram of a tack cartridge in accordance with the principles of the present disclosure; 
         FIG. 5  is a plane view of a tack cartridge in accordance with the principles of the present disclosure; and 
         FIG. 6  is an enhanced view of a handle of a tack delivery system showing a tack cartridge slot. 
         FIG. 7  is a diagram illustrating a tack delivery system according to an embodiment of the present invention. 
     
    
    
     Like reference numerals indicate similar parts throughout the figures. 
     DETAILED DESCRIPTION OF THE INVENTION 
     The exemplary embodiments of the surgical tack delivery system disclosed are discussed in terms of medical devices for dental and/or orthopedic applications for securing membranes and/or maintaining spaces. 
     It is envisioned that the surgical tack delivery system disclosed provides a reliable and safe access to a dental or orthopedic region to secure membranes and/or maintain spaces. It is further envisioned that the surgical tack delivery system is configured to deliver one or more tacks to the dental or orthopedic region to securing membranes and/or maintaining spaces. 
     The system and methods of the present disclosure may also be used on animals, bone models and other non-living substrates, such as, for example, in training, testing and demonstration. 
     The present invention may be understood more readily by reference to the following detailed description of the invention taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this invention is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed invention. Also, as used in the specification and including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. 
     The following discussion includes a description of a surgical tack delivery system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference will now be made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning now to  FIGS. 1-7 , there are illustrated components of a surgical tack delivery system  10  in accordance with the principles of the present disclosure. 
     Surgical tack delivery system  10  is configured to deliver a tack in dental and/or orthopedic application for securing membranes and/or maintaining spaces. The invention relates to a system for attaching tacks to bone, having a shaft  1  with a channel  2  extending therefrom and adapted to receive a tack  3 . The upper end of the shaft  1  includes a shaft lip  40 . The shaft  1  extends upward into a handle  4 . The lower end of the handle has a handle lip  41 . Shaft  1  and handle  4  are slidably connected and, at rest, shaft lip  40  and handle lip  41  are in contact and prevent shaft  1  from separating from handle  4 . Spring  39  provides a force to maintain contact between shaft lip  40  and handle lip  41  in the at rest position. Shaft  1  has a slot  5  that is in communication with the shaft  1 . The slot  5  is adapted to receive a tack cartridge  6 . The tack cartridge  6  is adapted to include a plurality of tacks  3 . The handle  4  includes a driving mechanism  15  to apply a force in the direction of the shaft  1  to a head of a tack  3  in the tack cartridge  6 . When the tack cartridge  6  is inserted into the slot  5 , a tack  3  is aligned with the channel  2  and the driving mechanism  15 . When a distal end  7  of the shaft  1  is placed against a location at which a tack is to be installed and pressure is applied to the handle  4  in a direction of the shaft  1 , the pressure compresses spring  39  and pushes driving mechanism  15  onto tack  3 . As shown in  FIG. 2 , continued pressure pushes driving mechanism  15  to push tack  3  into channel  2  and onto surface of work piece  38  (e.g. bone). Then as shown in  FIG. 3 , the driving mechanism  15  applies its force to direct the tack  3  into the bone  38 . As the pressure is released, spring  39  provides a force to return shaft  1  and handle  4  to their at rest positions. In its return to the at rest position, as driving mechanism clears the slot  5 , the tack cartridge  6  advances tacks  3  to align another tack  3  with the channel  2  and the driving mechanism  15 . 
     In a preferred embodiment all parts are of circular cross section and hence easily made. The surgical tack delivery system  10  comprises an elongated tubular casing  16 , which houses an elongated plunger  17  between an unattached ball  18  and a slidable hammer member  19 , and also has a retractable bit  20 ; said ball being between said plunger  17  and said retractable bit  20 . A compression coil spring  21  biases said hammer member  19  towards said plunger and forces said hammer member to normally rest against a seat  22 . A second compression coil spring  23 , biases said plunger  17  against said ball  18 , and hence said ball bears against the butt end head  24  of said pointed bit. A third compression coil spring  35 , biases said retractable bit  20  against said ball  18 . 
     The casing  16  consists of the tubular member  25 , which at hammer-end is closed by a cap  26 , serving as an anchor for the coil spring  21  which bears against said hammer member  19 , and said tubular member  25  has an extension  27  at its other end which serves as the slide bearing for the retractable bit  20 ; said cap and extension, being threadedly engaged to the respective ends of said tubular member  25 , to permit adjustment of the initial stress in said springs  21  and  23  respectively. Said member  25  has a constricted passage  28  intermediate its ends, thereby offering the seat  22 , and as an anchorage for the coil spring  23 , the seat  29 . The constriction  28  is of circular cross section and is co-axial with the hammer member  19 , the latter&#39;s socket  31 , and the retractable bit  20 . The head  32  of the plunger  17  that bears against the ball  18 , and the distal end of the head  24  of the retractable bit  20 , are semi-spherical in shape and of a diameter preferably slightly less than that of the ball  18 . The diameter of said ball must be such in relation to the diameter of the bore  33  it is in, that the plunger  17  and the retractable bit  20  shall never contact each other. It is best that the ball&#39;s diameter be more than the radius of said bore  33 . It is essential that dimensions be so chosen that when the tool  15  is in normal rest condition as shown in  FIG. 1 , the plunger  17  shall be slanted to the axis line of the hammer member  19  and preferably bear against the wall of the constricted passage  28 . It is suggested that the diameter of said ball  18  shall be a minimum of 10% larger than the radius of said bore  33  and a minimum of 10% smaller than the diameter of said bore. 
     The plunger  17 , near head end, has a flange  34  to seat the coil spring  23 , and from there, has three successive sections indicated by the numerals  35 ,  36  and  37  respectively. The section  35  is of a diameter adapted to slidably fit in the constricted passage  28 . The stem section  37  is of a reduced diameter adapted to slidably fit into the hammer&#39;s socket  31 . The section  36  is frustoconical and merges with said other sections. The spring  23  which biases the plunger  17 , is relatively weak as compared with the comparatively strong spring  21  which biases the hammer member  19 . 
     Although a mechanical spring-loaded driving mechanism is illustrated, other driving mechanisms are contemplated. Whichever particular driving mechanism is utilized, a driving force is applied to set a tack into the bone. 
     In one alternate embodiment of the present invention, a pneumatic driving mechanism is utilized. The pneumatic driving mechanism utilizes pressurized gas or air to provide the driving force to the retractable bit  20 . The air for the pneumatic driving mechanism can be supplied by any of various well-known systems, including, but not limited to, cartridge-based pneumatic systems, compressor-based pneumatic systems, or pump-action pneumatic systems. A compressor-based pneumatic system is shown in  FIG. 7 . Many hospital operating rooms include access to compressed air generated by an air compressor  53 . The surgical tack delivery system  10  can include an air hose connection  51  that in turn can be connected to an air hose  52 . Air hose  52  can attach to an air compressor  53  through various means, including wall plate  54  and hose  55 . The compressed air supplied from air compressor  53  can be used to supply the driving force to the retractable bit  20  to drive a tack  3  into the work piece  38 . Whichever pneumatic system is used, the single-handed operation of the surgical tack delivery system  10  is still maintained. 
     To operate the surgery tack delivery system  10 , it is set so that the distal end  7  of the shaft  1  is on that point on the surface  38  of a bone at which a tack  3  is to be inserted. The surgical tack delivery system  10  is in the condition shown in  FIG. 1 . Now, the handle  4  is pressed towards the bone, whereupon as shown in  FIG. 2 , more of the retractable bit  20  will move into the casing, thereby causing the plunger  17  to shift against the hammer member  19 , and move it away from the seat  22 . In addition, handle  4  will slide down over shaft  1 . Springs  21 ,  23  and  39  will become compressed and upon continuing such movement of the casing, the plunger  17  will be cammed and get into alignment with the hammer member  19 , whereupon the hammer will be freed to be forced by the fully stressed spring  21 , to move towards the retractable bit  20 , because the plunger section  37  will enter the socket  31  and receive the hammer&#39;s blow as shown in  FIG. 3 . The impact will be transmitted to the retractable bit  20  and onto the tack  3  and forcing the tack  3  into the bone. Upon removal of the pressure on the handle, the stressed spring  23  will restore the plunger  17 , and hence also the ball  18  and the retractable bit  20 , to normal rest position as shown in  FIG. 1 , and the tool will then again be ready for its next use. 
     When as in  FIG. 3 , the plunger  17  comes into axial alignment with the hammer  19 , the ball  18  is never in such alignment, and it is found that upon every operation of surgical tack delivery system  10 , that said ball  18  will receive some turning movement and change its position along the wall of the bore  33 . Hence, the points of impact of said ball and plunger head  32  and the points of impact of said ball and the bit&#39;s head  24 , change from one stroke of the tool to the next, thereby eliminating wear on just definite points as was the experience in prior devices of this class. 
     It is to be particularly noted that the ball  18  will always position the plunger  17  off center and to a slant position as shown in  FIG. 1 , when the retractable bit  20  extends its maximum out of the casing  16 , and such action is not effected when the butt end of said bit is flat instead of semi-spherical as herein shown. 
     The tack cartridge  6  is comprised of a casing  11  having a tack guide  13  formed therein. A spacing  14  shaped to fit a tack  3  is included in the casing  11 . Plunger  8  is biased by spring  9  to apply a force in the direction of hole  12 . As tacks  3  are loaded into the tack cartridge  6 , plunger  8  compresses spring  9 . When the tack cartridge  6  is inserted into slot  5 , hole  12  aligns with shaft  1  to allow for a tack  3  to be driven from the tack cartridge  6  down through shaft  1 . When a tack  3  is ejected from the tack cartridge  6  by driving mechanism  15 , plunger  8  forces remaining tacks  3  toward hole  12  until a foremost tack  3  is centered in hole  12 . 
     In another embodiment of the present invention, the surgical tack delivery system  10  can be modified in a manner such that the retractable bit  20  stabilizes the tack  3  at the work piece  38 . In order to accomplish the stabilization, the retractable bit  20  can be modified. In one such example, the retractable bit  20  can be magnetized and the tack  3  can be composed of a magnetic material; thus when contact is made between the retractable bit  20  and the tack  3 , the tack will remain attached thereto until embedded into the work piece  38 ; this allows for one-handed operation of the tack delivery system, even without the use of the tack cartridge  6 . In another example, the retractable bit  20  can include a suction tip to provide an attaching force between the retractable bit  20  and the tack  3 ; the suction tip can be a small suction cup that has a diameter less than the diameter of a head of a tack  3 ; thus when the suction force is applied between the retractable bit  20  and the tack  3 , the tack will remain attached thereto until embedded into the work piece  38 ; this again allows for one-handed operation of the tack delivery system, even without the use of the tack cartridge  6 . And in yet another example, the retractable bit  20  can include an interference/slip-fit end that can mate with a tack  3 ; the interference/slip-fit end can be a recess in the retractable bit  20  the inside diameter of which is greater than the diameter of a head of a tack  3 , such that the head of the tack  3  fits somewhat snuggly into the recess in the retractable bit  20 ; thus when the tack  3  is fitted into the recess of the retractable bit  20 , the tack will remain stabilized until embedded into the work piece  38 ; this yet again allows for one-handed operation of the tack delivery system, even without the use of the tack cartridge  6 . Although several examples have been described, the concept of providing a stabilizing force between the retractable bit  20  and the tack  3  can allow for one-handed operation of the surgical tack delivery system  10 . 
     Another embodiment of the present invention is directed to a method for delivering a surgical tack to a site in a surgical procedure. The method comprises providing a driver containing a tack cartridge having a plurality of tacks contained therein. The cartridge can be inserted at the time of use or the driver can be provided with the cartridge preloaded. Once the driver and the cartridge is positioned in place, the driving mechanism and a shaft of the driver provides pressure on the handle in the direction of the distal end of the channel of the driver. The pressure provides a driving force for the driving mechanism and the driving force is transferred to the first tack in the cartridge to drive the first tack into the tissue and/or membrane. Once this is completed a second tack is automatically or manually moved into alignment with the driving mechanism and said shaft so that the next tack can be delivered. This procedure is repeated until no more tacks are needed or until the cartridge is depleted of tacks. In latter case, another cartridge can be inserted and the process repeated. 
     Assembly, operation and use, of the surgical tack delivery system is employed with a surgical procedure for treatment of a spine of a patient including vertebrae V, intervertebral disc I and body areas adjacent thereto, as discussed herein. The surgical tack delivery system may also be employed with other surgical procedures, such as, for example, discectomy, laminectomy, fusion, laminotomy, laminectomy, nerve root retraction, foramenotomy, facetectomy, decompression, spinal nucleus or disc replacement and bone graft and implantable prosthetics including plates, rods, and membranes, as well as various dental procedures. 
     In use, the surgical tack delivery system of the present invention, a medical practitioner obtains access to a surgical site in any appropriate manner, such as through incision and retraction of tissues. It is envisioned that the surgical tack delivery system may be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery and percutaneous surgical implantation, whereby the surgical site is accessed through a mini-incision, or sleeve that provides a protected passageway to the area. Once access to the surgical site is obtained, the particular surgical procedure is performed for treating the disorder. The surgical tack delivery system is then employed to augment the surgical treatment. It is contemplated that the surgical tack delivery system can be used and manipulated by the surgeon using a single hand thereby leaving the other hand of the surgeon free. 
     The components of surgical tack delivery system and the tacks used therein can be fabricated from materials suitable for medical applications, including metals, polymers, ceramics, biocompatible materials, tissues, and/or their composites, depending on the particular application and/or preference of a medical practitioner. For example, the components of surgical tack delivery system, individually or collectively, and which may be monolithically formed or integrally connected, can be fabricated from materials such as stainless steel, stainless steel alloys, titanium, titanium alloys, super-elastic titanium alloys, cobalt-chrome alloys, shape memory materials, such as super-elastic metallic alloys (e.g., Nitinol, super-elastic plastic metals, such as GUM METAL® manufactured by Toyotsu Material Incorporated of Japan), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO 4  polymeric rubbers, biocompatible materials such as polymers including plastics, metals, ceramics and composites thereof, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, and epoxy. Various components of surgical tack delivery system may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, degradability, biomechanical performance, durability and radiolucency or imaging preference. Components alternatively could be prepared from allogeneic or xenogeneic tissues, tissue composites, or biomaterial/tissue composites. 
     The surgical tacks of the surgical tack delivery system can be coated or dusted with a particulate material, which may include an osteoconductive material such as hydroxyapatite and/or osteoinductive agent such as a bone morphogenic protein to enhance bone growth. The hydroxyapatite may be contained within tack material as a nanocrystalline particulate or coating. 
     It is contemplated that the tacks used in the delivery system may include therapeutic antibiotics, polynucleotides or polypeptides, which can be packed or otherwise disposed on or within the tacks. It is further contemplated that the tacks may include biocompatible materials, such as, for example, biocompatible metals and/or rigid polymers, such as, titanium elements, metal powders of titanium or titanium compositions, sterile bone materials, such as allograft or xenograft materials, synthetic bone materials such as coral and calcium compositions, such as hydroxyapatite, calcium phosphate and calcium sulfite, biologically active agents, for example, gradual release compositions such as by blending in a bioresorbable polymer that releases the biologically active agent or agents in an appropriate time dependent fashion as the polymer degrades within a patient. Suitable biologically active agents include, for example, bone morphogenic protein (BMP), Growth and Differentiation Factors proteins (GDF) and cytokines. 
     In one embodiment, the surgical tacks are fabricated from a resorbable material. It is contemplated that the tacks are fabricated from a biodegradeable material that resorbs over time in vivo. Examples of such include, but are not limited to, polyglycolide, polylactide, polycaprolactone, poly(ethylene glycol), polyurethanes, polyfumarates, polyacrylamides, collagen, silk, polyamines, polysaccharides, tissue or tissue products, and copolymers and blends thereof. It is further contemplated that struts  22 ,  30  can be adjusted and/or trimmed to the configuration and dimension requirements of a particular application. 
     In one embodiment, a driver as well as a plurality of pre-loaded cartridges or free tacks that can be inserted into a reloadable cartridge of various configurations and sizes may be packaged as a system or kit that includes additional bone graft growth material. In such an embodiment, the kit may include one or a plurality of cartridges, free tacks, drivers, and other materials for treatment. 
     In one embodiment, biologically active agents may be coated onto the exterior of one or all of the tacks and/or applied thereto for gradual release such as by blending in a bioresorbable polymer that releases the biologically active agent or agents in an appropriate time dependent fashion as the polymer degrades within a patient. Suitable biologically active agents include, for example, bone morphogenic protein (BMP) and cytokines. 
     One or all of the components of tacks may include one or a plurality of agents that can be configured as drug depots with medication for pain and may include antibiotics and/or therapeutics. It is envisioned that the agents may contain active agents and may include one or a plurality of therapeutic agents and/or pharmacological agents for release, including sustained release, to treat, for example, pain, inflammation and degeneration. The agents may include pharmacological agents, such as, for example, antibiotics, anti-inflammatory drugs including but not limited to steroids, anti-viral and anti-retroviral compounds, therapeutic proteins or peptides, therapeutic nucleic acids (as naked plasmid or a component of an integrating or non-integrating gene therapy vector system), and combinations thereof. 
     The agent may also include analgesics or anesthetics such as acetic acid derivatives, COX-2 selective inhibitors, COX-2 inhibitors, enolic acid derivatives, propionic acid derivatives, salicylic acid derivatives, opioids, opioid/nonopioid combination products, adjuvant analgesics, and general and regional/local anesthetics. 
     The agent may also include antibiotics such as, for example, amoxicillin, beta-lactamases, aminoglycosides, beta-lactam (glycopeptide), clindamycin, chloramphenicol, cephalosporins, ciprofloxacin, erythromycin, fluoroquinolones, macrolides, metronidazole, penicillins, quinolones, rapamycin, rifampin, streptomycin, sulfonamide, tetracyclines, trimethoprim, trimethoprim-sulfamthoxazole, and vancomycin. 
     The agent may also include immunosuppressives agents, such as, for example, steroids, cyclosporine, cyclosporine analogs, cyclophosphamide, methylprednisone, prednisone, azathioprine, FK-506, 15-deoxyspergualin, prednisolone, methotrexate, thalidomide, methoxsalen, rapamycin, leflunomide, mizoribine (Bredinin™), brequinar, deoxyspergualin, and azaspirane (SKF 105685), Orthoclone OKT™ 3 (muromonab-CD3). Sandimmune™, Neoral™, Sangdya™ (cyclosporine), Prograf™ (FK506, tacrolimus), Cellcept™ (mycophenolate motefil, of which the active metabolite is mycophenolic acid), Imuran™ (azathioprine), glucocorticosteroids, adrenocortical steroids such as Deltasone™ (prednisone) and Hydeltrasol™ (prednisolone), Folex™ and Mexate™ (methotrxate), Oxsoralen-Ultra™ (methoxsalen) and Rapamuen™ (sirolimus). 
     It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.