Patent Document

[0001]     This application claims the benefit of the priority of U.S. Provisional Application Ser. No. 60/549,275, filed on Mar. 2, 2004, entitled “Temperature Biased Suture Needle,” which application is incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates to a surgical instrument assembly for use in suturing inside internal body cavities of a patient, and more specifically to an instrument assembly for use in conjunction with a flexible or rigid endoscope to suture tissue within the body. This invention has particular applicability for suturing in conjunction with an endoscope inside internal body cavities of a patient, for example, inside the abdomen by gaining access through an existing orifice.  
       BACKGROUND OF THE INVENTION  
       [0003]     In a conventional abdominal surgical procedure, one or more incisions are created in the abdominal wall in order to enter the abdominal cavity. Surgical procedures to remove diseased tissue or organs are currently performed via open or laparoscopic surgery. In addition to major abdominal operations such as colon resection, gall bladder removal, and stomach resections, surgery for morbid obesity (bariatric surgery) is being performed with greater and greater frequency due to the increasing prevalence of morbid obesity and its complications.  
         [0004]     The high incidence of obesity its related medical problems have reached epidemic proportions in the United States affecting more than 30% of the adult population and accounting for nearly 300,000 deaths annually. Bariatric procedures most commonly performed include vertical banded gastroplasty, gastric banding, and Roux-en-Y gastric bypass (RNYGB). Morbidity and mortality resulting from these operations is relatively high.  
         [0005]     These complex and invasive surgical procedures require general anesthesia, surgical incisions, lengthy periods of time in the hospital, significant use of medication for management of postoperative pain and lengthy periods of convalescence. Surgical procedures to treat morbidly obese patients have a high incidence of complications and thus limit the number of patients who can benefit from these procedures. Surgery for morbid obesity is currently performed through a large abdominal incision. The operation entails exclusion of a large portion of stomach, and a bypass procedure of the small intestine. Oftentimes the patient has had prior surgery causing adhesions, which bind the intestines together. In that case the surgeon must first dissect these adhesions and free the bowel in order to reach the operative site.  
         [0006]     While laparoscopic surgery, which is a less invasive procedure, has become the standard of surgical care for numerous disease processes, complications from laparoscopic bariatric surgery are comparable to those resulting from open procedures. The surgery is technically more difficult and takes two to three hours longer than the open operation. Consequently longer anesthesia time is required, increasing patient morbidity. In order to perform gastric bypass surgery laparoscopically, the abdomen requires distention with air, which impinges on the patient&#39;s lungs thereby decreasing breathing capacity.  
         [0007]     Providing an option for surgery that may be performed through an existing orifice via the flexible endoscope would offer a less invasive approach. Because flexible endoscopic procedures are classically performed under conscious sedation and do not require an incision to enter the body, they are naturally less invasive. Consequently, morbidity and mortality would be reduced, convalescence time and hospital stay would be shortened, post-operative pain virtually eliminated and cost savings provided.  
         [0008]     Yet, such procedures are currently limited to examinations that include biopsy and polypectomy within the lumen of the gastrointestinal tract. One of the significant reasons for this limitation is the lack of the ability, with current surgery assemblies and techniques, to perform suturing and/or stapling through the narrow working channel of the flexible endoscope.  
         [0009]     Although there appear to be no commercial devices on the market that enable suturing through the working channel of the flexible endoscope, U.S. Pat. No. 5,037,433 to Wilk et al. describes an endoscopic suturing device that comprises an endoscope and a needle having a mechanical spring bias construction tending to bend the needle into an arcuate configuration. The needle is disposed in a straightened configuration while inside the endoscope. The surgical instrument further comprises an ejector device in the form of an elongate flexible rod member slidably disposed inside the inner tubular member proximally of the needle for ejecting a needle, which mechanically assumes an arcuate configuration subsequent to its ejection.  
         [0010]     Based on the disclosure and drawings of the &#39;433 patent, the mechanical spring biased or elastic tendency of the needle tends to bend a needle in an arcuate configuration. As such, this pre-stressed plastic or metal needle may be deformed (i.e. straightened) by mechanical stresses on the needle being confined in a generally straight biopsy channel of an endoscope, deforming the needle to render it generally straight. The mechanical stresses are provided and maintained by the walls of the biopsy channel into which the needle is inserted. Once the needle is ejected out of the biopsy channel by a rod, the stresses are removed, and the free needle immediately assumes its pre-stressed arcuate configuration under the direction of its normal elastic properties.  
         [0011]     The device described in the &#39;433 patent presents the various drawbacks and problems. First, the flexible endoscope is constructed in such a fashion as to allow only a 1 cm “stiff length” or less to pass through its biopsy or working channel. Any embodiment with a stiff length longer than 1 cm will not be capable of being passed through the working channel when the endoscope is bent, and will prevent the flexible endoscope from bending when housed inside its working channel. Consequently, only a device that is sufficiently malleable to bend relatively easily along with the endoscope may be passed through its working channel. Suturing requires a rigid needle shaped in an arcuate form. When such a needle is plunged into the target tissue in one location, it will exit the tissue at a second location in a predictable manner because of the needle&#39;s arcuate configuration and stiff or rigid state. Accordingly, there are two important requirements that a suture needle must fulfill if it were to be used through the working channel of a flexible endoscope. On one hand, it must be malleable enough to be passed through the working channel of a flexible endoscope while an endoscope is bent to its maximum capacity, while on the other hand it must assume a rigid arcuate state in readiness for the suturing operation upon ejection. If the spring biased needle described in the &#39;433 patent were to be sufficiently malleable to be passed through the working channel of an endoscope, it would surely be too malleable to enter and exit tissue in a reliable fashion. If a needle were to be formed from a material stiff enough to effectively and consistently enter and exit tissue, it would surely not be malleable enough pass through the working channel of a flexible endoscope.  
         [0012]     A further problem that the device described in the &#39;433 patent presents is its lack of anticipation of the difficulty presented in grasping the suture needle with the manipulation device. Just as in open and laparoscopic surgery, a suture needle must be grasped firmly so as not to rotate on its axis during the plunging of a needle into tissue. If the needle is permitted to rotate on its own axis it will only push against the tissue but will not enter it. Grasping a needle with jaw-closure-force being transmitted through a short rigid shaft, as is done during open or laparoscopic surgery is significantly different from grasping a needle with closure force being transmitted through a long flexible shaft. The latter forces required to close the jaws tightly are infinitely greater than in the former case. The &#39;433 patent does not address such an issue. No special construction of the needle&#39;s shaft to enhance grasping is described, and the description of the grasping device does not anticipate any of the abovementioned difficulty.  
         [0013]     Lastly, the &#39;433 patent does not address the attachment of the suturing thread to the needle. Spring biased metals do not behave as stainless steel does. In the case of the stainless steel suture needle, the suture thread is inserted into a cavity at the proximal end of the needle and the metal is crimped over the thread. In the case of a needle made of a spring biased metal, the metal is too soft to retain the thread by mere crimping.  
         [0014]     Therefore, it would be desirable to address the shortcomings and drawbacks of the prior art and to specifically provide an instrument assembly for suturing in p laces internal to a patient&#39;s body utilizing flexible or rigid endoscopes inserted primarily, though not exclusively, through existing body orifices.  
         [0015]     It is further desirable to provide such an instrument assembly for performing surgery through said endoscope, whereby an instrument assembly may be passed through the narrow, preferably flexible working channel of said endoscope.  
         [0016]     It is also desirable to address suturing concerns with a needle that is malleable enough to go through the working channel of the endoscope without inhibiting said endoscope&#39;s bending maneuverability, and yet, for suturing, is a rigid arcuately-shaped needle for use during a suturing operation.  
         [0017]     It is still further desirable to grasp a needle with an instrument that would be deliverable through narrow, convoluted working channel of a flexible endoscope, and yet would be capable of grasping the needle firmly and securely.  
         [0018]     It is desirable to provide an associated method for suturing through an endoscope, supplementing or replacing the more invasive surgical procedures, and reducing the complications and drawbacks of existing open or laparoscopic surgical procedures particularly those performed for morbid obesity.  
         [0019]     The benefits of the present invention in addressing the drawbacks and shortcomings of the prior art and the objectives and needs noted above will be more readily apparent from the description and drawings of the invention set forth herein.  
       SUMMARY OF THE INVENTION  
       [0020]     The present invention is directed to a surgical endoscopic suturing system to be used in conjunction with an endoscope. The invention relates to suturing of internal body tissues as part of a surgical procedure which may be diagnostic, therapeutic or both. In accordance with the present invention, there is provided an endoscopic surgery system comprising a temperature biased suture needle, a needle grasping device, and an elongated catheter or other delivery tube, a endoscopic surgery system configured for use in conjunction with an endoscope insertion member material that may become transformed from a malleable to a rigid state and vice versa. As such, a suture needle is sufficiently malleable to be passed through the working channel of the flexible endoscope. When a needle is ejected from the working channel in readiness for suturing, it may be treated in a particular manner to transform a needle into a rigid state, appropriate for suturing tissue.  
         [0021]     In one embodiment of the present invention, the suture needle is configured of a temperature biased shape memory alloy Nitinol (NiTi). The Nitinol alloy selected for a needle takes on a desired arcuate shape and stiffness appropriate for suturing when heated to a certain temperature. When cooled below a specific temperature, it does, in turn assume a malleable state. The ability to return to the previously defined shape when subjected to the appropriate thermal procedure is the basis upon which the temperature biased suture needle functions in accordance with the principles of the present invention. Accordingly, the temperature at which the suture needle will be in a heated state may vary. For example, in one embodiment, the suture needle is in a heated state at a temperature proximate body temperature. In another embodiment, the suture needle is in a heated state at a temperature above body temperature.  
         [0022]     The needle-grasping device manipulates the suture needle. Pursuant to a particular feature of the present invention, the needle-grasping device is configured to firmly grasp the suturing needle, enabling a needle&#39;s passage through the working channel of the endoscope insertion member, and performance of the suturing operation in a consistent and reliable manner. Pursuant to an embodiment of the present invention, the needle-grasping device is made of a rigid material such as stainless steel, and is comprised of a handle mechanism, a long flexible shaft, and a jaw assembly. According to a particular feature of the present invention, the jaw assembly is configured such that the inner surfaces of the grasping jaws possess a series of ridges, specially designed to firmly grasp the suture needle thereby preventing its rotation on its own axis during the suturing operation. The control mechanism for opening and closing the jaw assembly is comprised of one or more wires traversing through the shaft of a needle grasping device, a wires being configured to transmit mechanical compressive and tensile forces to enable alternating opening and closing of jaws. The wire(s) are operatively connected to a handle mechanism proximally, and to jaw assembly distally.  
         [0023]     In one embodiment of the needle-grasping device pursuant to the present invention, the handle mechanism comprises two finger rings operatively coupled with two leverage joints, a leverage joints being operatively connected with the wire that traverses the shaft of a needle-grasping device, the distal end of a wire being coupled with the jaw assembly. When said finger rings of the handle mechanism are pulled apart, a leverage joints are co-jointly pulled in opposing directions, thereby relaxing the pull on the wire. The relaxation of the wire causes said jaws to open. When the finger rings of the handle mechanism are approximated together thereby approximating a leverage-joints, a strong pull is created and applied onto the wire, causing the jaws to close tightly, thereby enabling a firm grasp of the suture needle.  
         [0024]     The delivery tube or tubular member is configured to house the needle grasping device and suture needle while being passed through the working channel of the endoscope insertion member. In one particular embodiment of the present invention, a collar comprises the distal end of the delivery tube, serving to protect the working channel of the endoscope insertion member from the sharp needle point, while enabling its exit from the flexible shaft of a delivery tube without piercing it. A locking mechanism may be included in the handle mechanism in order to lock said jaws in a closed position over the needle during the suturing operation.  
         [0025]     An additional alternative embodiment of the present invention, wherein the temperature control system utilizes electricity for providing heat to the suture needle, includes an electrical source providing electrical power, such as an electrical generator. The electrical source is operatively connected to an electrical connector and current is passed through said electrical connector and through an appropriate low resistance connection that is coupled to one or both of the high resistance metal jaws of the needle-grasping device. This delivery of power (e.g., electrical current) to a jaw assembly causes the jaws, and subsequently the needle that is being grasped by said jaws to become heated, thereby transforming a needle into its austenitic state. When the suture needle requires withdrawal at the termination of the procedure, cold water may be injected through the designated channel in the needle-grasping device directed to flow over a suture needle, thus rendering it malleable for withdrawal.  
         [0026]     Alternatively, the collar that comprises the distal end of the delivery tube may be heated to direct heat to the needle. In another embodiment of the present invention, a delivery tube includes insulated low resistance wires coupled to a connector. The wires may extend along and be imbedded in the shaft of delivery tube. An electrical source is operably connected to an electrical connector thereby passing electrical power through said electrical connector and down the low resistance wires. The wires are distally connected to a high resistance metal collar. As current is transmitted along this embodiment, the metal collar becomes hot, thus transmitting heat to the needle thereby causing it to assume its arcuate rigid state. Upon the need for withdrawal, cold water is injected as described.  
         [0027]     An associated minimally invasive surgical suturing method utilizes the above-described endoscopic surgical suturing assembly and comprises inserting a distal end portion of the endoscope insertion member into a patient in order to visualize the targeted tissue for suturing. The method further comprises inserting the suture needle grasped by needle grasping device, a needle-grasping device being housed inside the delivery tube, into the working channel of the endoscope insertion member. Upon visualization of target tissue in need of a suturing, a tubular member-containing needle grasping device and needle is ejected from the working channel of the endoscope, while a needle is in its malleable, martensitic state. The suture needle is then positioned proximate the target tissue, and heated by utilizing the temperature control system preferably by injecting hot water, thereby transforming a needle to its arcuate, stiffened austenitic state in preparation for the suturing operation. Upon transformation of a needle to its suturing state, the operator manipulates the needle through target tissue by means of the endoscopic insertion member and needle-grasping device, thus performing the suturing operation. Upon completion, state of the art endoscopic scissors are utilized to sever the suture thread. Thereafter, cold water is injected through the channel in the delivery tube or the needle grasping device, thereby transforming a needle to its malleable, martensitic state in preparation for withdrawal of a needle from the patient through the working channel of a endoscope insertion member.  
         [0028]     These embodiments and others are described in further detail below. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0029]     A complete understanding of the present invention may be obtained by reference to the accompanying drawings, when considered in conjunction with the subsequent, detailed description.  
         [0030]      FIG. 1  is a schematic perspective view of the distal end of the endoscopic surgical assembly in accordance with the present invention.  
         [0031]      FIG. 2  is a schematic perspective view of an embodiment of a suture needle.  
         [0032]      FIG. 3  is a schematic perspective view depicting a temperature biased suture needle in the malleable (martensitic) state emerging from the working channel of an endoscope.  
         [0033]      FIG. 4  is a schematic perspective view depicting an endoscope employing the suturing assembly approaching the tissue targeted to be sutured.  
         [0034]      FIG. 5  is a schematic perspective view depicting a curved suture needle in its stiff (austenitic) state being held by the needle-grasping device just prior to introduction into the targeted tissue.  
         [0035]      FIG. 6  is a schematic perspective view depicting the curved suture needle in its stiff (austenitic) state being maneuvered by the endoscope to enter the targeted tissue.  
         [0036]      FIG. 7  is a schematic perspective view depicting the curved suture needle in its stiff (austenitic) state emerging from the tissue and being re-grasped by the needle-grasping device.  
         [0037]      FIG. 8  is a schematic perspective view of the suture needle in its malleable (martensitic) phase being pulled back into the working channel of the endoscope after completing one stitch of the suturing operation.  
         [0038]      FIG. 9  is a schematic perspective view of a suture needle depicting the needle shaft configured in a triangular “cutting” shape, and the needle&#39;s proximal end shaped with ridges.  
         [0039]      FIG. 9A  is a schematic perspective end view depicting a needle-grasping device holding a needle.  
         [0040]      FIG. 9B  is a schematic perspective end view depicting yet another needle grasping device holding a needle.  
         [0041]      FIG. 9C  is a further schematic perspective end view depicting a needle-grasping device holding a needle.  
         [0042]      FIG. 10  is a schematic perspective view of the distal end of the delivery tube and needle-grasping device, depicting a fluid port built into the wall of the delivery tube.  
         [0043]      FIG. 11  is a schematic perspective view of one embodiment of the present invention assembly depicting the proximal end of a needle-grasping device with an electrical temperature control system.  
         [0044]      FIG. 12  is a schematic perspective view of one embodiment of the present invention assembly depicting perspective view of the needle grasping device configured injection of fluid onto the temperature biased suture needle.  
         [0045]      FIG. 13  is a schematic perspective view of the needle grasping device jaw assembly configured with a ridged surface disposed on the inner aspect of each jaw.  
         [0046]      FIG. 13A  is a further schematic perspective view of the needle grasping device jaw assembly configured with a ridged surface disposed on the inner aspect of each jaw.  
         [0047]      FIG. 14  is a schematic perspective view of the present invention depicting a fluid channel configured into the shaft of a needle-grasping device.  
         [0048]      FIG. 15  is a schematic perspective view of another embodiment of the invention depicting the needle-grasping device coupled to an electrical source.  
         [0049]      FIG. 16  is a schematic perspective view of yet another embodiment of the invention depicting the needle-grasping device with low electrical resistance conductive wires imbedded along its shaft.  
         [0050]      FIG. 17  is a schematic view of an embodiment of the needle grasping device handle assembly in the open configuration in accordance with the present invention.  
         [0051]      FIG. 18  is a schematic view of an embodiment of the needle grasping device jaw assembly in the open configuration in accordance with the present invention.  
         [0052]      FIG. 19  is a schematic view of an embodiment of the needle grasping device handle assembly in the closed configuration in accordance with the present invention.  
         [0053]      FIG. 20  is a schematic view of an embodiment of the needle grasping device jaw assembly in the closed configuration in accordance with the present invention.  
         [0054]      FIG. 21  is a schematic side view of an embodiment of a grasping jaw.  
         [0055]      FIG. 22  is a perspective view of the jaw in  FIG. 21 .  
         [0056]      FIG. 23  is a sectional side view of the jaw in  FIG. 21 . 
     
    
       [0057]     For purposes of clarity and brevity, like elements and components will bear the same designations and numbering throughout the figures.  
       DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0058]     As illustrated in  FIG. 1  an endoscopic surgery system or surgical assembly comprises a temperature biased suture needle  10 , a needle-grasping device  18 , and an elongated catheter or other delivery tube or tubular member  12 , shown emerging from working channel  14  of an endoscope insertion member  15 . Delivery tube or tubular member  12  is configured for insertion into the working channel  14  of endoscope insertion member  15 . Needle grasping device  18  includes a flexible or rigid elongated shaft, a handle mechanism and a jaw assembly with jaws, and is movable within delivery tube  12  and is configured for grasping and manipulating suture needle  10 . Suture needle  10  is shown in a straight malleable (martensitic) state  11  in dashed lines, and in a stiff, hardened, austenitic state  13 . Suture needle  10  is in its malleable state  11  for passage through or manipulation inside working channel  14  of endoscope insertion member  15 , and in its hardened arcuate shape for suturing tissue. Suture needle  10  illustrated in  FIG. 1  is a temperature biased suture needle, whereby in one particular embodiment it is made of a nickel titanium (NiTi) alloy such as Nitinol. In the embodiment of a needle in accordance with the present invention, the Nitinol alloy selected for the needle  10  takes on a desired shape (arcuate) and stiffness appropriate for suturing when heated to a certain temperature, and becomes malleable when cooled below a specific temperature.  
         [0059]     The term Shape Memory Alloys (SMA) is applied to that group of metallic materials that demonstrate the ability to return to some previously defined shape or size when subjected to a certain strain. Although a relatively wide variety of alloys are know to exhibit the shape memory effect, it is preferable, in accordance with the principles of the present invention to use a specific shape memory alloy that can return to a previously defined shape when subjected to the appropriate thermal procedure. This material can be plastically deformed at some relatively low temperature, while upon exposure to a higher temperature will return to its predetermined shape prior to the deformation. When such a temperature biased SMA is subjected to temperatures below its transformation temperature, it has very low yield strength and can be deformed quite easily into any new shape. However, when the material is heated above its transformation temperature it undergoes a change in crystal structure that causes it to return to its original shape.  
         [0060]     The mechanical properties of temperature biased SMAs vary greatly over the temperature range spanning their transformation. The martensite (malleable low temperature phase) is easily deformed to several percent strain at quite a low stress, whereas the austenite (stiff high temperature phase) has much higher yield and flow stresses. Upon heating, the metal remembers its unstrained shape and reverts to it as the material transformed to austenite.  
         [0061]     The basis of the nickel-titanium system of alloy is the binary, equiatomic intermetallic compound of NiTi. The intermetallic compound is extraordinary because it has a moderate solubility range for excess nickel or titanium, as well as most other metallic elements, and it also exhibits ductility comparable to most ordinary alloys. This solubility allows alloying with many of the elements to modify the temperature transformation properties of the system. Excess nickel, in amounts up to about 1%, is the most common alloying addition. Excess nickel strongly depresses the transformation temperature and increases the yield strength.  
         [0062]     In accordance with the present invention, the needle of the invention is made of a shape memory alloy of nickel and titanium. The needle has a special ratio of Ni to Ti, whereby it assumes a malleable, or martensitic, state when chilled and a rigid, or austenitic, state when heated. In one embodiment, the Ni to Ti ratio is such that the transition temperature from martensitic (malleable) to austenitic (rigid) is between 30° C. (±3) and 39° C. (±3°). In a more specific embodiment, the Ni to Ti ratio is such that the austenite (rigid) start temperature (A s ) is in the range of 30° C. and its austenite (rigid) finish temperature (A f ) is in the range of 39° C. In another embodiment, the needle assumes its austenitic (rigid) state at a temperature proximate body temperature. In still another embodiment, the needle assumes its austenitic (rigid) state at a temperature above body temperature.  
         [0063]     Delivery tube  12  is shown in  FIG. 1  with metal collar  16  at its distal end. Collar  16  is configured to protect the suture needle tip during insertion of the suturing assembly through the endoscope working channel. Metal collar  16  may also be used to transmit heat to suture needle  10  thereby activating the austenitic arcuate (curved) form of a suture needle  10 . As discussed in detail below, collar  16  may be coupled to a temperature control system that may include a standard electrosurgical generator. When a generator is coupled with the suturing assembly and activated, an electrical current would be transmitted to collar  16  heating it, and thereby transmitting a heat to suture needle  10 . Delivery tube  12  might also contain one or more hollow lumens or channels, at least part way along the wall of the tubular member and configured for directing fluid from a port located in or near the proximal handle assembly onto to suture needle  10 . Needle grasping device  18  is used to guide suture needle  10  out of delivery tube  12  and may preferably also be used as a source of heat for suture needle  10  to activate the shape memory. As such, needle grasping device  18  may be coupled to the electric temperature control system and/or have one or more hollow lumens or channels longitudinally along its shaft or in its shaft proximally coupled to a port in or near the handle assembly of needle grasping device  18  and used as discussed further herein.  
         [0064]      FIG. 2  is a schematic perspective representation of suture needle  10  in its curved austenitic state, coupled with a suitable suture  17 . Suture needle  10 , in one embodiment, is made from a temperature biased shape memory metal, for example, Nitinol, and is configured to include a sharp distal tip  21  for piercing tissue. In this preferred embodiment of the present invention, Needle  10  is depicted to have a shaped shaft with a generally triangularly shaped cross-section with sharpened cutting angles for easy passage through tissue. The proximal end  20  of suture needle  10  is securely attached to an appropriate length of suture thread  17 , such as biocompatible glue, for example.  
         [0065]      FIGS. 3-8  are schematic views of an endoscope employing the endoscopic surgical assembly of  FIG. 1 , showing successive steps in a suturing operation pursuant to the invention.  FIG. 3  is a schematic perspective view of suture needle  10 , delivery tube  12  with metal collar  16  emerging from the working channel  14  of a multi-channel endoscope insertion member  15 . Targeted tissue  30  to be sutured is shown as well. Suture needle  10  is in a generally straight configuration and is in its malleable martensitic phase at a temperature below the heated state as it is ejected from the distal end of the delivery tube  12  by needle grasping device  18  housed inside delivery tube  12 .  
         [0066]      FIG. 4  is a perspective view of suture needle  10 , needle grasping device  18  and metal collar  16  emerging from one working channel of endoscope insertion member  15 . In this figure needle-grasping device  18  is holding suture needle  10  coupled with suture  17 . The needle is still in the malleable martensitic state because heat has not yet been applied to suture needle  10  to activate its shape memory.  
         [0067]      FIG. 5  is a schematic perspective view of needle grasping device  18  holding curved suture needle  10 . Needle  10  is in its rigid, curved, austenitic state after heat has been applied to it in order to activate its shape memory. Suture  17  and targeted tissue  30  to be sutured are shown as well.  
         [0068]      FIG. 6  is a schematic perspective view of needle grasping device  18  emerging from delivery tube  12  with metal collar  13 , a suturing assembly being employed by endoscope insertion member  15 . Needle grasping device  18  has a firm hold on curved suture needle  10 , a needle being guided into target tissue  30  with the aid of endoscope insertion member  15 , and needle-grasping device  18 . Suture  17  is securely attached to proximal end of suture needle  10 .  
         [0069]      FIG. 7  is a schematic perspective view of curved suture needle  10  emerging from targeted tissue  30  and being captured by needle grasping device  18 . Suture  17  is pulled through targeted tissue  30  as suture needle  10  is passed, thus forming a loop of suture  17 , which may be tied to approximate and secure tissue in the desired position.  
         [0070]      FIG. 8  is a schematic perspective view of the distal end of suture needle  10  being pulled back into delivery tube  12  while a suture line cutter  32  is passed through another working channel  14  of the endoscope insertion member  15 . Suture cutter or scissors  32  is used to sever suture needle  10  from suture  17  after a knot has been tied to secure tissue in preferred position. Upon grasping of suture needle&#39;s distal tip by needle grasping device  18 , cooling of suture needle  10  may take place by injection of cold water through a specially allocated channel in needle grasping device  18 , or delivery tube  12 , to be shown further below. This cooling process transforms suture needle  10  into its malleable or martensitic state, thus facilitating its removal through the working channel  14  of endoscope insertion member  15 , along with excess suture  17 .  
         [0071]      FIG. 9  is a schematic perspective view of an alternative embodiment of suture needle  10  wherein the shaft of suture needle  10   a  has a cross-section with a generally triangular shape, with the three angles of the triangle being sharply formed, configured for cutting and easy passage through the tissue. The proximal end  22  of needle  10   a  is flattened with a rectangular cross section, a flattened portion&#39;s surfaces configured with a series of ridges  23 , a ridges corresponding to similar ridges located in the inner surface of the jaw assembly of needle grasping device  18 , ( FIG. 10 ) to provide a better hold of the needle by a jaws. Most particularly, the hold that is desired is one that would not allow for suture needle  10   a  to rotate on its own axis during the process of suturing tissue.  
         [0072]      FIGS. 9A, 9B , and  9 C illustrate alternative means and embodiments for grasping and manipulating needle  10   a  with needle grasping device  18 . Alternatively, the proximal end of suturing needle  1  may be constructed in a triangular, rectangular or circular cross section. The cross-sectional configuration of a portion of the needle may be circular, rectangular, or triangular.  
         [0073]      FIG. 10  represents a perspective view of one embodiment of the present invention wherein heated or cooled fluid  37  is used to transform suturing needle  10  from an austenitic to a martensitic state, and vice versa. A fluid port  34  is coupled to one or more channels disposed or fashioned longitudinally along the delivery tube  12  for directing warm fluid through a channel in tube  12  and out its distal end for the purpose of bathing a needle and transforming it into its hardened arcuate state. Delivery tube  12  might include a separate channel  35  for the fluid  37  or the fluid may traverse through the passage or channel, which extends through the delivery tube  12  in which the needle-grasping device  18  is positioned. When suture needle  10  requires withdrawal through working channel  14  of endoscope insertion member  15 , fluid port  34  is utilized in order to direct cooled or cold fluid to bathe suture needle  10 , thereby transforming it into its malleable state. Fluid port  34  may be coupled with a temperature control system  36  that includes supplies of hot  38  and cold  39  fluids, or fluids of varying temperature. A syringe, for example may be used for the purpose of injecting fluid to port  34 .  
         [0074]      FIG. 11  represents a schematic perspective view of an alternative embodiment showing the port  34  located proximate the handle  26 . Port  34  is operably coupled with delivery tube  12  and with a temperature control system that may include heated or cooled fluid ( FIG. 10 ). Warm fluid may be injected into injection port  34  and directed along delivery tube  12  to exit at fluid port  38  at the distal end of the tube  12  bathing the suture needle and thereby causing its transformation into the hardened state. Alternatively, when the needle requires withdrawal, cold water is injected rendering suture needle  10  malleable.  
         [0075]      FIGS. 12 and 14  illustrate a schematic perspective representation of another embodiment of the invention wherein the fluid is directed through the needle-grasping device. Referring to  FIG. 14 , the needle-grasping device includes a fluid channel  40 , which extends along at least a portion of the length of the needle-grasping device and is coupled with injection port  34  ( FIG. 12 ). The fluid channel  40  terminates in an outlet  42  proximate jaw assembly  24  of the needle holding device. In this preferred embodiment, fluid channel  40  conducts heated or cooled fluid  37 , injected into injection port  34 , to fluid outlet  42  at the distal end of needle grasping device  18 , causing the desired deformation and shaping of suture needle  10 , in accordance with the invention.  
         [0076]      FIGS. 13 and 13 A are perspective views of needle grasping device jaws  24  with ridges  25  placed onto the inner surfaces of said jaws. Ridges may be cut into various patterns with embodiments having vertical or horizontal ridges down the inside of both jaws ( FIG. 13A ). Another embodiment may be configured with diagonal ridges, while another, with ridges cut into a checkerboard pattern ( FIG. 13 ) or diamond pattern.  
         [0077]      FIGS. 15 and 16  illustrate additional alternative embodiments of the invention wherein the temperature control system is electric in nature and utilizes electricity for providing heat to the suture needle  10 . The embodiment depicted in  FIG. 15  illustrates a temperature control system  44  that includes an electrical source  48  providing electrical power, such as an electrical generator. Electrical source  48  is operatively connected to an electrical connector  46  and electric current is passed through electrical connector  46  and through an appropriate low resistance connection that is coupled to one or both of the high resistance metal jaws of the needle grasping device  18 . This delivery of power (e.g., electrical current) to jaw assembly  24  causes the jaws, and subsequently the needle that is being grasped by said jaws to become heated, thereby transforming needle  10  into its rigid state. When suture needle  10  requires withdrawal at the termination of the procedure, cold water may be directed toward the distal end of delivery tube  12  flowing over suture needle  10  rendering suture needle  10  malleable for withdrawal as discussed above. A locking mechanism may be included in the handle mechanism in order to lock jaws  24  in a closed position over the needle during the suturing operation. The system might include a lock button  48  for this purpose ( FIG. 15 ). Alternatively, collar  16  of delivery tube  12  may be heated to direct heat to the needle.  FIG. 16  illustrates an embodiment that includes insulated low resistance wires  50  coupled to connector  46 . The wires may extend along and be imbedded in the shaft of tubular number or delivery tube  12 . An electrical source  48  may be operably connected to electrical connector  46  thereby passing electrical power through electrical connector  46  and down the low resistance wires  50 . The wires  50  are distally connected to high resistance metal collar  16 . As current is transmitted along this embodiment, metal collar  16  becomes hot, transmitting heat to needle  10 , and causing it to assume its arcuate rigid state. Upon the need for withdrawal, cold water is injected as described above.  
         [0078]      FIG. 17  illustrates another embodiment of the needle-grasping device in an open configuration. Push-pull wire  62  traverses through shaft  68  or is incorporated into the shaft and is operably connected to jaw mechanism  66  distally and leverage-joints  70  proximally. When opposing scissor finger rings or handles  64 A and  64 B of the device are pulled apart or separated, leverage-joints  70  are co-jointly pulled in opposing directions or separated, thereby relaxing the pull on wire  62  and moving the wire in a distal direction toward jaws  74 A,  74 B causing jaws  74 A and  74 B to open.  FIG. 18  is a detailed illustration of jaw mechanism  66  depicting jaws  74 A and  74 B in an open position. Flush port  60  ( FIG. 17 ) is designed for introduction of hot or cold water, which flows through a separate channel in shaft  68  (Illustrated in  FIG. 20 ) and bathes the temperature biased suture needle in jaw mechanism  66 . The needle-grasping device includes a ratchet locking structure  65  to hold the scissor finger rings together tightly to grasp the needle.  
         [0079]      FIG. 19  illustrates the preferred embodiment of the needle grasper in a closed configuration. Scissor finger rings  64 A,  64 B are approximated, causing leverage-joints  70  to be brought together or approximated, thereby applying a strong pull on wire  62 . As a result, jaws  74 A and  74 B are approximated together tightly, allowing for a firm grasp of the suture needle. The ratchet locking structure  65  is shown locked to hold the jaws together.  FIG. 20  is a detailed schematic representation illustrating tightly closed jaws  74 A and  74 B. Flush channel  78  that communicates with flush-port  60  is illustrated in  FIG. 20 .  
         [0080]      FIGS. 21 and 22  depict a detailed drawing of jaws  74 A and  74 B. The proximal aspect of the jaws, namely leg  80 , is operatively coupled to wire  62 , allowing for secure closure of the jaws. The jaws  74 A,  74 B each include a leg  80  and a pivot opening  84  to receive a pin or other pivot element for pivoting. The legs  80  are at an angle to the toothed portion of the jaws. As the legs are spread apart, the jaws spread apart ( FIG. 18 ). Scissor linkages  81  are pivotally coupled to each leg  80  at respective pivot points or pivot pins at one end. The other ends of the scissor linkages  81  are appropriately coupled at another pivot point  83  to cable  62 . When scissor ring fingers  64 A,  64 B are brought together, the cable  62  slides in a distal direction and cable  62  is pushed or relaxed ( FIG. 17 ). The distance between the pivot points  83 ,  84  is reduced and the jaws open and when cable  62  is pulled or tensioned ( FIG. 19 ), the jaws close.  FIG. 22  depicts one construction of the jaws. Their broader proximal and narrower distal ends adds leverage to the grasping force of the needle shaft. Teeth  82  situated on the inner aspect of the jaws, depicted in even greater detail in  FIG. 23  are constructed so as to correspond with the ridges on the needle&#39;s proximal end, thereby providing for a secure grip of a needle.  
         [0081]     While the present invention has been illustrated by a description of various embodiments and while these embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and method, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of applicant&#39;s general inventive concept.

Technology Category: 1