surgical clamp, cartridge and kit

专利摘要:
surgical clamp, cartridge and kit. some embodiments refer to a clamp comprising: a part of the base (101); opposing first and second arms (107, 108) coupled to the base part (101); and an opposing first and second clamp (102) coupled to the respective first and second arms (107,108), the opposing first and second clamp (102) each having a part extending into the base part (101); wherein at least the base part (101) is formed of a memory alloy so that it tends to force the first and second arms (107, 108) towards each other when a temperature of the base part (101) reaches or exceeds a transformation temperature of the base part (101).
公开号:BR112013014075B1
申请号:R112013014075-5
申请日:2011-12-07
公开日:2021-02-23
发明作者:Mikhail Soutorine；Artem Nikolaevich Chernov-Haraev；Sergei Dmitrievich Prokoshkin；Elena Prokopievna Ryklina；Irina Yurievna Khmelevskaya；Andrey Victorovich Korotitskiy；Rouslan Valereevich Ipatkin
申请人:Globetek 2000 Pty Ltd；The Federal State Autonomous Educational Institution Of The Higher Professional Education National University Of Science And Technology Misis；
IPC主号:

专利说明:

CROSS REFERENCE TO RELATED REQUESTS
[0001] This application claims priority for International Patent Application No. PCT / RU2010 / 000735, filed on December 12, 2010, the complete content of which is hereby incorporated by reference as if written in this document. TECHNICAL FIELD
[0002] The embodiments described generally refer to metal clamps, such as surgical clamps, and therefore to handling devices. Such embodiments can be applied, in general open and endoscopic surgery (laparoscopy). Concretizations can be used for operations such as cholecystectomy, appendectomy, gastrectomy, semi-colectomy, background application, cardiovascular interventions and other operations that require tissue cutting or clamping in vessels. BACKGROUND
[0003] In some situations, it is necessary to close a tubular structure, for example, in order to prevent the further flow of a fluid through the structure. This may be desirable during a surgical operation, for example, where a blood vessel or other tubular structure has to be closed temporarily or permanently. A clamp or clamp device can be used for this purpose.
[0004] Many situations require the closure of the tubular structure, so that it is temporary, in which case, for blood vessels, it may be important to allow blood to flow normally again through the vessel, once reopening is allowed. It can also be advantageous to avoid damage to the blood vessel during its closure, for example, due to excessive compression, roughness or perforation.
[0005] A prior art relates to a method for laparoscopic anas tomosis (RU 2241391, published on 10.12.2004), in which a cooled sterile clamp is placed inside the conveyor lumen by opening the clamp clamps in the form of 'V' and fixing it with its rear projections. The clamp is released and placed inside the prepared holes, loosening it with the traction of the conveyor, with the support of the pusher. When heated, the clamp closes its clamps and compresses the walls of hollow organs. A disadvantage of this method is its limited functionality, that is, the impossibility of recovering blood flow in the hollow tubular elastic organ (the "vessel").
[0006] Another technique refers to a method of stapling elastic tubular structures (RU 2213529, published on 10.10.2003). This method is performed by compressing an organ by a clamp made of a biologically inert alloy with a unilateral and reversible memory effect. Before application, the clamp is deformed at a temperature below the implantation temperature to give it an easy way to install. The tissue is sutured with the pointed end of the clamp, the clamp is positioned at an application site to close the lumen (cavity) of the vessel. The clamp is removed at a temperature below the implantation temperature as the clamp partially opens.
[0007] A disadvantage of this method is the limited time left for handling and installing the clamps, as the clamp clamps are closed when the clamp temperature is reached, which is close to body temperature. In addition, perforation of the fabric with a pointed end of the clamp is necessary for secure clamping of the clamp, which is unacceptable for operations in thin vessels. In addition, this method implies that a very significant cooling of the body tissues, where the clamp is applied, is necessary to remove the clamp, which can have serious consequences, or can be difficult to implement.
[0008] Another technique involves a staple for the anastomosis of hollow organs (RU 2285468, published on 10/20/2006). The clamp contains a long double winding wire. The spiral is fixed along its entire length to ensure a compressive interaction and has loose wire ends at one end of the spiral, which is made of a nickel-titanium (NiTi) alloy with super shape and memory effect -elasticity. Both wires from each coil of the coil for the most part at the second end of the coil are straightened and closed together to achieve mutual contact and form the linear wires. The result is the extension of the application area due to the anastomosis of small hollow organs, without making extensive holes, causing damage or violating its physiology.
[0009] A deficiency of these staples is the ability to invade the anastomosis procedure since additional tissue perforation is necessary using bandages. There is also no procedure to remove the clamp without causing additional trauma.
[00010] Another technique that involves a clamp (RU 2213529, published on 10.10.2003) formed from biologically inert material, with a simple and reversible memory effect, which allows the stapling of vessels and tubular organs, as well as the fixation of the tissues by means of suture, at the same time. The clamp can be removed later, if necessary, as in the case of a cavity and laparoscopic procedures. The clamp consists of a rounded or flattened clamp, which is bent so that one side forms a circular or elliptical curve, and the other side forms two parallel clamps closely adjacent to each other, of which at least one has a bent ear in the shape of a ski. There are grooves on the inner side of the clamps, providing a reliable self-locking mechanism for the clamps in a frame.
[00011] The deficiency of these clamps is the lack of secure fixation in tubular organs and the inherent risk of slipping during the pulsation of the organ or accidental mechanical contact with surgical instruments. Other disadvantages are inherent to the complexity of the procedures for their application and removal.
[00012] Another technique involves a surgical manipulator (RU 2109488, published on 27/04/1998), in which the working end of a manipulator manages a pair of clamps, with the ability to open and close them. A guide node is movably mounted on the opposite end of the manipulator, and is able to interact with the transmission of the fixation and an implantation mechanism. The tubular structure of the manipulator is covered with an electro-insulating layer and contains a cavity for a cooling element. The manipulator allows a term element to be incorporated into the cavity of the structure, which works through a Peltier thermoelectric effect by cooling the compression element with thermomechanical memory.
[00013] Disadvantages of the device are in the difficulties with the design: invasiveness of the device and the inability to remove the suture elements. Peltier elements are used to keep the suture elements permanently low in order to preserve their elastic state at the time of delivery and release. Such a design leads to a rapid heating of the Peltier elements and the possible premature release of the shape memory effect, before the suture elements are replaced. Another disadvantage of this device is that the shape memory elements can be used only once; it is also impossible, or at least impractical to adjust them after they have been applied in cases of inadequate application to the connecting fabrics.
[00014] Another technique involves a device for applying clamps (RU 2362498, published on 07/27/2009), which contains a rod with working branches, a feeding mechanism in the form of a movable cover, a transmission with a structure and a plate on the inner surface of which are the stops, the height of which is a multiple of the length of the clamp. The plate with the stops is fixed to the distal end of an additional surface of the stem with sponges. The plate is able to move in relation to the stem. It is also spring loaded on the other side of the movable cover. The movable cover is spring loaded by the additional spring installed on the rod with sponges on the transmission side. A fixed sleeve is installed between the springs, and a movable sleeve is installed at the distal end. Dimensions of the movable glove are chosen in order to ensure their interaction with the projections, made on the inner surface of the movable structure. Mounting surfaces in the form of grooves and stops for the initial installation of the plates are installed at the distal end of the movable structure.
[00015] A disadvantage of this device is that the suture elements can be used only once and can be difficult to remove without trauma. It is also not practical to use this device for stapling vessels due to increased trauma and the risk of bleeding.
[00016] Another technique involves a device for the application of clamping clips (RU 2052979, published on 01/27/1996), which includes a structure with the mounting surfaces for the deposit of clamps, work sponges, a transmission and a feeding mechanism. The feeding mechanism is connected to the structure with guide slots and spring loaded handles installed in these grooves. The handles are connected to a wrapper placed inside the lid, which contains a support surface and holes to see through. A movable cover is installed at the end of the cover, on the inner surface on which the stops are, the height of which is a multiple of the length of the clamp. The stops are able to interact with the support surface and the holes to see through them. A counting mechanism for the clamps is installed on the outer surface of the cover. The structure of the feeding mechanism is designed as a moving part of the transmission, which is equipped with the terminal clamping surfaces, which are capable of rotating the sponges.
[00017] A disadvantage of this device is that the suture elements can be used only once and can be difficult to remove without trauma. It is also not practical to use this device for stapling vessels due to increased trauma and the risk of bleeding.
[00018] Any discussion of documents, practices, materials, devices, articles or the like that have been included in this specification is not to be taken as an admission that any or all of these matters form part of the background of the prior art or were known to exist general common in the relevant field of the present invention as it existed prior to the priority date of each claim in this application.
[00019] Throughout this specification, the word "comprise" or variations such as "comprises" or "comprising", will be understood to indicate the inclusion of a declared element, integer or step, or group of elements, integers or steps, however, not excluding any other element, integer or step, or group of elements, integers or steps. SUMMARY
[00020] Some embodiments refer to a clamp comprising: A part of the base; A first and second opposing arms coupled to the base part; and First and second opposing clamps coupled to the respective first and second arms, the first and second opposing clamps, each having an inward extension part that extends towards the base part; In which at least the base part is formed of a memory alloy so that it tends to force the first and second arms towards each other when the temperature of the base part reaches or exceeds a transformation temperature of the base part .
[00021] The part extending into each of the opposing first and second clamps may have an internal end that curves towards the respective first and second arms. An external surface of the clamp next to the base part and the first and second opposing boats can generally be smooth. The clamp can be made of biologically inert materials.
[00022] The first and second clamps may each have extreme parts that extend outward from the base part, the extreme parts having rounded ends. The first and second calipers are separable to adopt an open position in which the calipers are sharply angled in relation to each other. In the open position, the clamps cannot contact each other. When a shape memory of the base part is activated by heating the base part, the base part may tend to force the first and second clamps towards a closed position. In the closed position, the inwardly extending parts cannot contact each other. At least part of the base can be made of nitinol. The clamp can be a surgical clamp
[00023] Some embodiments relate to a cartridge that comprises a plurality of the clips described herein. The plurality of clips can be maintained on the cartridge in an open position.
[00024] Some embodiments refer to a kit comprising at least one of the staples described herein or the cartridge described herein and which further comprises a staple manipulator, the staple manipulator comprising: At least one arm to hold a staple, and At least one thermoelectric transducer to transmit a change in temperature to the base part of the clamp sufficient to cause the temperature of the base part to reach or exceed the transformation temperature. Some embodiments relate to the clamp manipulator as described above on its own.
[00025] In the kit, at least one arm can comprise two arms. In the kit, at least one thermoelectric transducer can be attached to a distal end of each arm or at least one arm. In the kit, at least one thermoelectric transducer can be operable to cool or heat the base part. In the kit, at least one thermoelectric transducer can comprise at least one Peltier element.
[00026] The kit of at least one arm of the clamp manipulator can comprise a distal pair of opposing clamps arranged with a thermoelectric transducer in each clamp, in which the opposing clamps are usable to simultaneously press the base part of the clamp and transmit with this the change in temperature.
[00027] Some embodiments refer to a clamp comprising: Opposing clamps, each clamp having the opposite first and second free ends and defining the respective opposite clamping surfaces, and A coupling part joining the opposite clamps, the coupling being joined to each clamp at an intermediate location between the free ends, where the coupling part is formed of a memory alloy so that the coupling part causes relative movement of the clamps in response to a change in coupling part temperature.
[00028] The embodiments generally refer to a new method and new tools that can be used to create reliable artificial hemostasis in hollow tubular organs while preserving the integrity of their internal structures. Embodiments aim to reduce or eliminate excessive thrombus formation and restore blood flow in a hollow tubular body after exposure to artificial hemostasis.
[00029] Some embodiments refer to a clamp made of alloy with memory in a way that helps to increase the reliability of the hemostasis, reduces the risk of a clamp accidentally slipping from a hollow tubular organ, and reduces the trauma caused when using the clamp .
[00030] In addition, the surgical and endoscopic manipulators described here can solve additional technical challenges. First, they can expand the functionality of a surgical manipulator and an endoscope, since the delivery, handling, application, removal and extraction of staples are performed with a single device, eliminating the need to use several tools. Second, they can reduce the intensity of work and trauma when working with a manipulator, as well as simplifying and improving the reliability of the manipulator.
[00031] Some embodiments refer to a method of closing a tubular organ, for example, to create hemostasis (ie, stop the flow of blood in a vessel), using the clamp described by applying heat to the clamp to make it close according to your shape memory. The method may also involve applying cooling to the clamp to make it at least partially open from its closed position and allow it to be removed, thereby allowing an organ lumen to open again and allow fluid flow. Heating and cooling can be applied using the same thermoelectric transducer elements on the same device. Methods for creating hemostasis and restoring blood flow to tubular elastic organs, as well as devices for performing such methods (medical clamp, surgical manipulator and endoscopic manipulator), are explained below.
[00032] Hemostasis and the restoration of blood flow in the elastic tubular organs can be created by means of a clamp, as described in this document, delivered to an application site with a manipulator. The manipulator holds the clamp by your ear through mechanical contact with the manipulator's work surfaces. The contact must be made with at least one Peltier element, located at a distal end of the gripper clamps. This method allows the elastic tubular organs to be deformed under pressure through counter-movement of the work surfaces of the clamp clamps. The clamps have been previously separated, at a temperature below the temperature at which the martensitic transformation in the material (transformation temperature) of the clamp ear begins. The pressure is generated by force transfer and the impulse to the clamp clamps through the clamp ear. Reactive stress (movement induced by tension) is generated in the clamp material, as a result of the effects of the shape memory alloy, which is activated as the temperature of the clamp ear rises through a thermal contact with the working surface of the elements. Peltier, which have been preheated. Then the direct contact of the clamp ear and the working surface of the Peltier elements is eliminated. However, as the clamp ear cools to reach body temperature, sufficient compression at the site of application of a tubular elastic organ is maintained to support hemostasis. The blood flow in the vessel can then be restored by the formation of a lumen in the tubular elastic organ. This lumen forms when the pressure of the clamp clamps drops and they partially open, which is a result of the temperature of the clamp ear material falling below the start temperature of martensitic transformation (transformation temperature) that occurs when the clamp ear contacts the working surface of the Peltier elements, which are switched to their cooling mode.
[00033] In some embodiments, the medical clamp is made of a biologically inert material compatible with living tissue and contains an ear, the end of which is connected with two clamps by means of two arches. Proximal ends of the clamps are located in the space between the arches. The ear of the clamp is made of an alloy with shape memory.
[00034] Some embodiments refer to a surgical manipulator that contains elastic tweezers, upper and lower arranged along one another with a space and connected by its proximal ends. The surface of at least the distal parts of the upper and lower elastic forceps is made of a biologically inert material. Transverse dimensions of these clamps are smaller than their longitudinal dimensions. Peltier elements are located at the distal ends of at least one of the clamps. These elements are connected to an electrical supply through insulated electrical conductors placed along the elastic clamps by means of at least one three-position switching block of Peltier elements.
[00035] Some embodiments refer to an endoscopic manipulator, which has two elastic clamps, at least one of which is mobile. The elastic clamps are mounted on the distal end of the manipulator; its surface is made of a biologically inert material. The Peltier elements are attached to the loose ends of at least one of the clamps. These elements are connected to an electrical supply through isolated electrical conductive wires placed inside an elastic hollow stem with a rotation mechanism, which is mounted between the proximal end of the stem and its handle. Peltier elements are connected via at least one three-position switching block. The other ends of the elastic clamps are crossed over the first connection node, which is installed at the distal end of the hollow elastic rod. The first connection node is connected to a pull rod passed through the hollow elastic rod and mobilely connected with the rear handle, which is mobilely connected with the front handle through the second connection node. One end of the rack mechanism is mounted on the rear handle and is passed through a hole in the front handle, the other end of which is equipped with a pressure plate.
[00036] Some embodiments refer to a method to create hemostasis and restore blood flow in tubular elastic organs, with specific devices to perform this method (medical clamp, surgical manipulator and endoscopic manipulator). Hemostasis to reestablish blood flow in elastic tubular organs is created by means of a clamp, delivered to an application site with a manipulator. The manipulator holds a clip by his ear through mechanical contact with the manipulator's work surfaces. Contact must be made with at least one Peltier element, located at the distal ends of the manipulator's clamps. This method implies that the elastic tubular organs are deformed under pressure through counter-movement of the work surfaces of the clamp clamps. The clamps have previously been separated at a temperature below the temperature at which martensitic transformation begins in the clamp ear material. Pressure is generated by transferring the moment of force to the clamp clamps through the clamp ear. Reactive stress is generated in the clamp material, as a result of the effects of the alloy with shape memory, which is activated as the temperature of the clamp ear rises through a thermal contact with the working surface of the Peltier elements, which were pre -heated. Then the direct contact of the clamp ear and the working surface of the Peltier elements is eliminated. However, as the clamp ear cools to reach body temperature, sufficient compression at the site of application of a tubular elastic organ is maintained to support hemostasis. In addition, blood flow is restored by forming a lumen in a tubular elastic organ. This lumen forms when the clamp clamp pressure drops and they partially open, which is a result of the temperature of the clamp ear material falling below the start temperature of martensitic transformation that occurs when the clamp ear contacts the working surface the Peltier elements, which are switched to their cooling mode.
[00037] The preliminary opening of the clamp clamps can be carried out at a temperature below approximately 20 ° C. The shape memory effect on the material of the clamp ear can take place at temperatures above approximately 35 ° C and within about 0.1 - 10 seconds. The blood flow can be totally or partially restored when a lumen is formed within a tubular elastic organ. The clamp clamps can partially open to restore blood flow to a temperature below approximately 20 ° C and within about 0.1 to 10 seconds. BRIEF DESCRIPTION OF THE DRAWINGS
[00038] The invention is illustrated by the following drawings: Figure 1 is a schematic representation of a medical clamp according to some embodiments; Figure 2A illustrates the clamp of Figure 1 in an open (cocked) state, that is, before being applied to a vessel; Figure 2B illustrates the clip of Figure 1 in a closed state being applied to a vessel and the compression of the vessel; Figure 2C illustrates the clamp of Figure 1 in a partially open state, when the clamp is being removed; Figures 3A, 3B, 3C, 3D and 3E illustrate several different possible shapes of the clamp ear; Figure 4 is a schematic side sectional view of a surgical manipulator for applying the clamp of Figures 1, 2A to 2C and 3A to 3E, including a switching block on the surgical manipulator; Figure 5 is a schematic side sectional view of an additional embodiment of the surgical manipulator for applying the clamp of Figures 1, 2A to 2C and 3A to 3E, including a remote installation of the power supply and a switching block; Figure 6 is a perspective view of the endoscopic manipulator for applying the clamp of Figures 1, 2A to 2C and 3A to 3E; Figure 7 is an enlarged perspective view of a distal end of the endoscopic manipulator of Figure 6; and Figure 8 is a schematic diagram in a partial perspective view of another embodiment of a surgical clamp manipulator. DETAILED DESCRIPTION
[00039] The embodiments described generally refer to metal clamps, such as surgical clamps, and therefore to handling devices. Such embodiments can be applied, in general to open and endoscopic surgery (laparoscopy). Embodiments can be used for operations such as cholecystectomy, appendectomy, gastrectomy, semi-colectomy, background application, cardiovascular interventions and other operations that require tissue clipping or clamping in vessels.
[00040] As used herein, the term "proximal" is a relative term, intended to quote a location, direction or position closest to the operator of the manipulation device. Thus, as applied to the clamp described herein, the term "proximal" is intended to indicate those parts of the clamp close to or adjacent to the base or "ear" of the clamp. In contrast, the term "distal" is a relative term, having a connotation opposite to "proximal" and intended to cite a location, direction or position distant (or extending away) from the operator of the manipulation device. As applied to the clamp described herein, the term "distal" is intended to indicate the parts of the clamp that are farthest from the base or "ear" of the clamp.
[00041] Medical clamp 100 in Figure 1, comprises an ear 101, a pair of jaws 102, arches 103, a proximal end of the clamp 104, a pair of work surface 105 of the clamp, a distal end of the clamp 106 (for conductive connection) a pair of Peltier elements and a light signaling device 111.
[00042] A surgical manipulator 151 is shown in Figures 4 and 5 comprising an upper clamp 107, a lower clamp 108, a distal end 109, Peltier elements 110, a light signaling device 110, a forced heating button 112, a forced-heating micro-key 113, forced-cooling button 114, forced-cooling micro-key 115, gripper clamping mechanism 116, thrust wedge 117, slider 118, guide groove 119, slider 120, a power source 121, a screw connection 122, wiring slots 123, an electrical connection 124, an electrical outlet 125, a proximal end 126, an electrical cable 127 leading to a pedal to switch modes (no shown).
[00043] The distal end of an endoscopic manipulator 152 is shown in Figure 7, which comprises a pair of tweezers 128, the elements of Peltier 129 and a first connection node 130 and isolated conductive wires 133.
[00044] An endoscopic manipulator 161 is shown in Figure 6, which comprises a distal end of the manipulator 152. An elastic hollow rod 131, a pull rod 132, conductive electrical wires 133, a rotation mechanism 134, a handle 135, a front handle 136, a rear handle 137, a second connection node 138, a rack mechanism 139, a stop for the rack mechanism 140, a pressure plate 141 for the rack mechanism, a through hole 142 in the front handle, a mounting slot 143 on the rear handle, a mounting rod 144, a finger hole 145 on the front handle, a button 146 for switching the Peltier element block, an electrical supply 147, a close end 148 of an electrical connector , a socket 149 for the electrical connector, an electrical supply 150 potentially leading to a pedal to switch the Peltier element block (not shown), equipped with an electrical supply, signal lights and / or a device audio asset (not shown).
[00045] The embodiments described generally refer to a new method and new tools for creating reliable artificial hemostasis in hollow tubular organs while preserving the integrity of their internal structures. The embodiments aim to reduce or eliminate the excessive formation of thrombi and allow the restoration of blood flow in the hollow tubular bodies exposed to artificial hemostasis. Each embodiment can solve a specific set of medical problems.
[00046] Specifically, the clamp made from one or more alloys with shape memory can help increase the reliability of hemostasis, can reduce the risk of accidental slipping of the clamp from a hollow tubular organ, and can reduce trauma when if a clamp is used.
[00047] In addition, surgical and endoscopic manipulators 151, 161 can address additional technical challenges through: • Improving the functionality of a surgical manipulator 151 and an endoscopic 161, as the delivery, handling, application, removal and extraction of 100 staples can be run with a single device, eliminating the need to use multiple tools. • Reduced work intensity and trauma when working with a 151/161 manipulator as well as simplifying and improving the reliability of the 151/161 manipulator.
[00048] The method for creating hemostasis and restoring blood flow in a tubular elastic organ, as well as the devices for carrying out this method (medical clamp 100, surgical manipulator 151 and endoscopic manipulator 161), is explained below.
[00049] Hemostasis and blood flow restoration in a tubular elastic organ 153 can be created using clamp 100, delivered (and, optionally, removed) to an application site with a 151/161 manipulator. The manipulator 151/161 holds the clamp 100 by its ear 101 through a mechanical contact with the manipulator's work surfaces (upper clamp 107 and lower clamp 108). Contact must be made with at least one Peltier 110 element located at the distal ends of the 107/108 manipulator clamps. This method implies that the elastic tubular organs 153 are deformed under pressure through the counter-movement of the work surfaces of the clamps of the clamp 102. The clamps 102 were previously removed at a temperature below the temperature of the start of the martensitic transformation (transformation temperature) in the ear material of the clamp 101.
[00050] A plurality of staples 100 can be stored together in a metal or plastic cartridge (not shown) of, say 10, 15, 20 or 30, staples 100. When in the cartridge, staples 100 are in the open position and are preferably cooled to a temperature below their martensitic transformation temperature so that they are not attached to the cartridge body and can be removed from the cartridge. This cooling can be carried out by using the 151/161 manipulator or by storing the cartridge in a cooling chamber.
[00051] Pressure is generated by transferring the moment of force to the clamps of the clamp 102 through the ear 101 of the clamp.
[00052] This clamping / clamping pressure generated by clamp 100 is not maintained through dependence on the shape memory alloy. Since the clamp 100 is in position, the mechanical strength of the clamp 100 is sufficient to hold it in the closed position, there is no dependence on the application of temperature to keep the ear of the clamp 101 above its transition temperature.
[00053] Reactive pressure is generated in the material of the clamp, as a result of the effects of the alloy with shape memory, which is activated as the temperature of the ear of the clamp 101 rises through a thermal contact with the working surface of the elements Peltier 110, which have been preheated. When direct contact between the ear of the clamp 101 and the working surface of the elements of Peltier 110 is eliminated, and the ear of the clamp 101 cools to reach body temperature, sufficient compression at the site of application of a tubular elastic organ 153 is maintained to support hemostasis. In addition, blood flow is restored by forming a lumen in a tubular elastic organ 153. This lumen is formed when the clamp 102 clamp pressure drops and they partially open, which is a result of the temperature of the ear material 101 of the clamp falling below the start temperature of the martensitic transformation (transformation temperature) that occurs when the clamp ear 101 contacts the working surface of the elements of Peltier 110, which are switched to their cooling mode. When the ear of the clamp 101 is sufficiently cooled, the clamp 100 will open at least partially, although it may not reopen as it was previously opened before closing.
[00054] The preliminary opening of the clamp clips 102 is carried out at a temperature below 20 ° C. The shape memory effect on the material of the clip ear 101 occurs at temperatures above approximately 35 ° C within a period of time. approximately 0.1 - 10 seconds. The restoration of the blood flow totally or partially is done as a lumen in the tubular elastic organ 153 is formed. Partial release of the clip 102 clamps restores blood flow to a temperature below approximately 20 ° C within a period of approximately 0.1-10 sec.
[00055] Medical clamp 100 is made of a biologically inert material compatible with living tissues and composed of an ear 101, the end of which is connected to two clamps 102 by means of two arcs 103. The proximal ends of the clamps 104 are located in the space between the arches 103.The ear of the clamp 101 is made of an alloy with shape memory.
[00056] Ear 101 of clip 100, in particular, is made of a medical alloy of nickel and titanium (NiTi). The ear 101 of the clip can have various shapes, such as: semicircular, elliptical, U-shaped, or zigzag as shown in Figures 3A, 3B, 3C, 3D, and 3E. The maximum permissible angle of the open clamps 102 and the level of the average compression force of the clamp are determined by the shape and size of the clamp ear 101.
[00057] The proximal ends of the clamps 104 are located in the space between the arches 103 and the ear of the clamp 101. Both clamps of the clamp 102 can be of equal or different length, varying in size from approximately 2 millimeters to 50 mm. The thickness of the two clamps of the clamp 102 can also be the same or different.
[00058] By varying the thickness of the clamps 102 and the ear 101, different levels of mechanical compression force can be achieved, allowing different clamps to be tailored to different sizes and strengths of the organ. The length of the clamps 102 can also be modified, depending on the size, shape and strength of the organ to be clamped. For each embodiment of the clamp, a range of sizes is contemplated, allowing the surgeon to select a clamp of the appropriate size for the procedure.
[00059] The entire working surface 105 of the clamps 102, or just localized parts, either has a straight smooth or wavy smooth or rough wavy front shape. The entire working surface 105 of the clamps 102, or only located parts, has straight or angled incisions. The entire working surface 105 of the clamps 102, or only located parts, has straight or angled protuberances.
[00060] The length of the arches of the clamp 103 does not exceed the length of the respective clamps of the clamp 102, and the thickness and width of the arches 103 depends on the thickness and width of the ear of the clamp 101.
[00061] The proximal ends 104 of the clamps 102 are illustrated in Figure 1. In the illustrated embodiments, the ends 104 have been curved and rounded and turned outwardly within the inner curvature of the ear 101. In this curved formation of the proximal ends 104, the the possibility that the tubular organ 153 is captured or engaged by the internal proximal ends 104 is minimized. This may not be a concern since the clamp 100 is in place, however in removing the clamp 100, it is possible that the organ 153 can extend to the proximal ends of the clamps 104, and if the proximal ends 104 are sharp instead of being rounded, the tubular member 153 can be captured or attached like the clamp 100.
[00062] The work surfaces 105 (i.e., the surfaces that engage and compress the tubular member 153) of the clamps 102 may have several different patterns of undulations, grooves or teeth, depending on the application of the clamp. These can be seen illustrated on the working surfaces 105 of the clamps 102 in Figure 1. These corrugations, grooves or teeth help the clamp 100, providing additional friction or the clamping ability, both in a lateral and horizontal direction (where the main mechanical force applied by clamp 100 is in the vertical direction). This additional friction can be advantageous in preventing the clamp 100 from being moved out of position, either by surgical instruments, or by the pulsation of the tubular organ 153 itself.
[00063] The contour of the work surfaces 105 of the clamps 102 is intended to generally provide a uniform diffusion of mechanical loads across all or most of the length of the work surfaces 105, and to avoid point loads and to identify pressure on any located area of the tubular organ 153. As the ear 101 begins to close and adopt its memorized shape, the arches 103 transmit the displacement to the clamps 102 and the working surfaces of the clamps 105 move towards the other. As the work surfaces 105 contact the tubular member 153, the member begins to compress and increases the contact surface with the clamp 101. Slight bending of the clamps 102 can occur near where the arches 103 become clamps 102, according to the clamp 100 is closed. The irregular distribution of the load over the tubular member 153 can cause damage to part of the member 153, so the shape and dimensions of the clamp are selected to allow the work surfaces 105 to adopt a spaced configuration, generally parallel in the closed form. This is intended to mitigate the possible clamping of the organ 153.
[00064] In some embodiments, the clip 100 may have a circular or rounded shape cutout 154, where each arc 103 is distally transformed into the clip 102, as shown in Figure 1. The cutout 154 can be partially formed in the clips 102 and partially in the arcs 103, adjacent to the working surface of the clamps 105. This cut has training benefits for the manufacture of the clamp 100 and can also reduce the possibility of uneven distribution of the load, avoiding having an excessively thick part in the middle of each clamp 102 If the cutout 154 is absent, this can lead to the ends of the clamps 102 having a relatively rigid center section and more flexible ends, thus increasing the possibility of overloading the organ 153 in the proximal ex-tremity of the clamps 104.
[00065] The lateral width of the clip 100 (that is, in a direction within the page, as can be seen in Figure 1) can vary, but it should generally be sufficiently wide and / or sufficiently rounded at its lateral edges to avoid or at least minimize the clamp 100 having a cutting effect on the fabric it tightens. This cutting effect can also be minimized by implanting a shape memory in the clamp 100 that does not make the clamps 102 fully close and instead leaves a small opening between them, in the closed position.
[00066] The level of distribution of the compression force along the length of the clamps of the clamp 102 is driven by the changing size of the arches 103, as well as the location of their contact with the clamps 102.
[00067] The entire clamp 100 can be formed from a biologically inert memory alloy material, allowing the clamp 100 to be left on the tubular organ 153 for long or indefinite periods of time, if necessary. Alternatively, a biologically inert coating can be applied to memory alloy materials reactively to reduce or eliminate short-term corrosion problems. The clamp 100 can be produced in embodiments of different sizes, materials and shapes, depending on the nature of the operation (the area of the body to be contacted) and the period during which the clamp 100 will remain in contact with the organ 153.
[00068] Surgical manipulator 151 contains upper and lower elastic tweezers 107 arranged along one another with a space and connected by their proximal ends.The surface of at least the distal parts of the upper and lower elastic tweezers 108 is made of a biologically inert material. In some embodiments, a biologically inert coating can also be applied over a portion of the elastic tweezers 107 and 108.
[00069] Transverse dimensions of these clamps are smaller than their longitudinal dimensions. Peltier 110 elements are located at the distal ends of at least one of the 107/108 clamps. These elements 110 are connected to a 121 of the power supply via insulated electrical conductive wires 123 placed next to the elastic clamps 107/108 through at least one three-position switching block (heating / cooling / neither) 112/114 of Peltier 110 elements.
[00070] In addition, the proximal ends of the upper 107 and lower 108 clamps are joined at a connection point or region, 122 by means of screws, welding, welding or gluing.
[00071] The upper clamps 107 and lower 108 in some embodiments are joined in a "special clamp", as a way through which the proximal ends closer to the surgeon's hand are permanently joined, allowing a flexible point of articulation, allowing the surgeon manipulates (that is, opens and closes) distal ends of the clamps 107 and 108 in relation to each other, with one hand if necessary. The upper and lower clamps 107, 108 are preferably predisposed to adopt a position in which they are slightly apart, so that in this relaxed open condition, the clamps can be positioned around the ear 101 of a clamp 100 and then gently tightened together to adopt a compressed inward position and hold the ear 101 (with the clamps 102 extending distally away from the manipulator) for the application of the clamp 100 as desired.
[00072] Transverse dimensions (width) of the upper 107 and lower 108 clamps may be of variable value over their entire length.
[00073] Elements of Peltier 110 are fixed by welding or screwing. A preferred method of fixing the elements of Peltier 110 is to weld or screw them in place permanently to the tweezers 107 and / or 108 although other methods of fixation may be contemplated, such as adhesives, welds, pins or nails, for example.
[00074] The power supply mechanism 121 provides AC or DC electrical current. Power supply 121 on any manipulator 151, 161 can be derived from an external AC or DC source and optionally converted to DC power by circuits within manipulator 151, 161 for DC control of Peltier elements.
[00075] The switching block of the Peltier elements can be made as a forced heating button 112 and a forced cooling button 114, installed in the middle of one of the clamps 107/108, opposite to which (in the other clamp) there is a micro-key for forced heating 113 and forced cooling 115, connected to a power supply mechanism 121 installed at the distal end of the upper clamp 107.
[00076] Location of the button on one side of the clamps 107/108 and the microswitch on the internal surface of the opposite arc, allows a surgeon to activate the said switches with a smooth and delicate movement, pressing the two clamps 107 and 108 in set. The gentle and delicate action of these movements is preferable during a surgical procedure, since any sudden movement or tugging can cause trauma to the tubular organ 153.
[00077] The mode switching block for the Peltier elements can also be made as a foot switch, equipped with a 121 power supply and connected to a surgical manipulator 151 via an electrical current socket 125 mounted on the distal ends of the upper and lower tweezers 107/108.
[00078] A switch actuator pedal can allow the surgeon to have even more control over the surgical manipulator 161, without the distraction or potential interference of keys in the 161 manipulator.
[00079] A mechanism for fixing the clamp positions 107/108 is located in the middle of the surgical manipulator 151. It is a mobile sliding control 118, a thrust wedge 117, which is rigidly connected to the lower clamp 108 and which passes freely through the hole in the upper clamp, guides 120 for the movable sliders 118 and the guide groove 119, located in the upper clamp 108. The movable slider 118 is located inside the guide groove 119 and is rigidly connected to its bottom 120.
[00080] The clamping mechanism 116 allows the position of the upper clamp 107 and the lower clamp 108 to be locked in place relative to each other. This allows the surgeon to release the clamps 107/108 and maintain control of the clamp 100 still in position. contact with the Peltier 110 elements.
[00081] Surgical manipulator 151 can be equipped with a signal light 111 and / or an audio device.
[00082] The audio / visual signal can be used to alert the user of a change from forced cooling to forced heating, for example, to alert when changes are made and / or to alert where accidental changes may have been initiated. Signal light 111 may emit different colors to indicate different states, such as, for example, a blue light to indicate a cooling state or a red light to indicate a heating state, for example.
[00083] The endoscopic manipulator 161 shown in Figures 6 and 7 has two elastic tweezers 128, at least one of which is movable; The elastic clamps 128 are mounted on the distal end 152 of the manipulator; its surface is made of a biologically inert material. The Peltier 129 elements are attached to the free ends of at least one of the clamps 128. These elements are connected to an electrical supply 147 through isolated electrical conductive wires 133 placed within an elastic hollow rod 131 with a rotation mechanism 134 , which is mounted between the proximal end of the rod and its handle 135. The elements of Peltier 129 are connected via at least one three-position switching block. The other ends of the elastic clamps 128 are crossed at the first connection node 130, which is installed at the distal end 52 of the elastic hollow rod 131. The first connection node 130 is connected with a pulling rod 132, passed through the elastic hollow rod 131 and movably connected with the rear handle 137, and is passed through a hole 142 in the front handle 136, the other end of which is equipped with a pressure plate 141.
[00084] A rotation mechanism 134 can be connected to the top of the front handle 136.The front handle 136 also contains holes 145 for the fingers.
[00085] The rotation mechanism 134 allows the orientation of the clamp 100 to be adjusted to adopt an appropriate position for the entry and exit to / from an internal surgical site and also for flexibility with the actual connection of the clamp 100. The The surgeon may release the clamp 100 during an operation, if necessary, to reorient the clamp 100 in relation to the clamps 128. However, it may be preferable that the clamps 128 can be rotated using the mechanism 134, and the clamp be continuously retained by the tweezers 128.
[00086] A flexible connection of the pull rod 132 with the rear handle 137 is made with the help of a mounting socket, which is placed at the top of the rear handle 137 above the second connection number 138. The head of the pulling rod 132 is inserted into this node 138.
[00087] The three-position switching block of the Peltier 129 elements can be made as a micro-key for forced heating (similar to 113) and forced cooling (similar to 115), mounted in front 136 or rear 137 handle and connected to a power supply 150, located on handle 136.
[00088] The three-position switching block of the Peltier 129 elements can also be made as a foot switch, equipped with a power supply and connected to the endoscopic manipulator 161 through an electrical socket 149 mounted on the handle .
[00089] The endoscopic manipulator 161 can be equipped with a signal light and / or an audio device to notify the user of the adjustment in which the elements of Peltier 129 are: hot or cold.
[00090] Reliable and damage-free hemostasis to restore blood flow to tubular elastic organs 153 can be achieved using medical clamp 100 with special instruments: a surgical manipulator 151 and / or endoscopic manipulators 161.
[00091] The embodiments are based on the principle of mechanical action, such as deformation, pressing down on elastic tubular organs, such as vessels, and fixing such a compressed position for a certain period of time. At the same time, it is possible to restore the lumen within previously compressed elastic tubular organs. This possibility would greatly facilitate the surgeon's work, and possibly shorten the duration of the surgery.
[00092] In other words, pressing down on a tubular elastic organ 153 such as a blood vessel and fixing the vessel in a compressed position for a period of time, using a clamp 100, causes temporary hemostasis within the vessel. However, the blood flow in the vessel can be restored by removing the clamp 100. It is still possible, using the clamp 100 and with the manipulator 151 or 161, to avoid substantial damage to a compressed organ, so that the lumen of the elastic tubular organ pill can naturally restore itself. This ability is of great advantage to a surgeon, and can possibly shorten the duration of a surgery.
[00093] The deformation of an elastic tubular organ 153 is carried out with the aid of medical clamp 100, made entirely or simply having a stable coating of a biologically inert material, compatible with human tissue. The use of such material is necessary in order to minimize any biochemical (toxic, carcinogenic) effects on health by clamps 100 on the body, which is especially important when clamp 100 is applied for a long time.
[00094] The ear 101 of the clamp or the entire clamp 100 is made of an alloy with shape memory, such as a medical nickel-titanium (NiTi) alloy. Its use is necessary to meet the specific mechanical characteristics (elastic - plastic, thermo - elastic and resistance) of medical clamps 100, which are essential to achieve a reliable and safe hemostasis in 153 tubular elastic organs and to restore blood flow through a safe removal (and without the use of brute force) of the previously applied clamp 100.
[00095] It is preferable that the clamp 100 is removed as smoothly as possible, as any use of force to remove the clamp 100 can cause greater damage to the organ 153 at the site of the temporary hemostasis.
[00096] The working principle of medical clamp 100 is based on the shape memory effect. The effect reveals the following. An alloy with shape memory usually resembles its original shape or cold molded, (shape memory), in such a way that the material can be deformed and mechanically twisted, but when applying heat, it will return to its remembered shape . The temperature at which this transformation takes place is known as the transformation temperature or the martensitic transformation temperature, due to the change in the internal phases of the material. If the clamp 100 is excessively deformed, outside its plastic zone and within elastic deformation, the shape memory characteristics of the clamp 100 can be damaged or lost and the clamp can no longer change between its open and closed positions with the application or withdrawal of thermal energy. The type of excessive deformation that could damage the shape memory effect is not created by the normal use of the clamp as the shape memory deformation generally remains within the plastic zone of the material characteristics.
[00097] Staple 100 is cut from an alloy sheet with shape memory and is then subjected to a heat treatment. This gives the clamp 100 a suitable shape for transport and application in the correct place, which is achieved through plastic deformation. This means that the clamp can be transported in its cold (open) form to the application site and when heat is applied to the ear of the clamp 101, it will return to its closed position (shape memory). Sheet of varying thickness can be employed to produce staples 100 depending on what size and mechanical strength is needed to effectively compress and maintain hemostasis in the organ. When heated, the clamp 100 will initially assume a specified shape (shape memory) of the closed clamps 102, as shown in figure (2B), by pressing down on an elastic tubular organ 153. When the clamp 101 ear is cooled, the clamps of the clamp clamp 102 will partially open upwards, as shown in Figure 2C, which allows for a trauma-free removal of clamp 100 or, if necessary, re-application of clamp 100.
[00098] Prior to the application of medical clamp 100 to an organ 153, clamp 100 is placed in a cocked (open) condition. The ear of the clamp 101 is pseudo-plastically deformed in advance, spreading the clamps 102, at a low temperature (below 20 ° C) to give it a shape as shown in Figure 2A, suitable for application to an organ 153.
[00099] Pseudoplasticity is an effect in which the material's austenitic phase is accentuated to induce the martensitic phase. When the stress load is relieved, the martensitic phase returns to its austenitic state and transforms itself back into its shape memory. While in this martensitic phase the alloy is capable of maintaining high levels of tension.
[000100] The clamps 102 are opened at a low temperature (below 20 ° C) so that the material of the ear 101 reaches a temperature close to a martensitic transformation temperature range (transformation temperature range). At this temperature the material becomes flexible and its elastic modules are strongly decreasing, while its plastic deformation will be accumulative to certain limits, due to a reversible mechanism of accumulation of the plastic deformation, this is due to a structural transition in stages oriented force caused by external force.
[000101] Nitinol is a metal alloy and, as such, is inherently flexible. Nitinol offers a favorable combination of mechanical and physical properties. In addition to its biocompatibility (a corrosion resistance similar to that of stainless steel), it is flexible (low Young modulus of approximately 75 GPa), has high UTS (approximately 750-960 MPa), exhibits polarized rigidity characteristics (rigid in compressions and flexible in tension) and exhibits its super-elastic behavior in a temperature range similar to that of the human body.
[000102] Nitinol structure is a cubic crystal lattice configuration, in its austenite phase and is extremely strong. The auspicious structure becomes a monoclinic crystal structure when the structure is cooled below the transformation temperature and the martensite becomes twinned within the nitinol. As the monoclinic structure is loaded, the martensite "de-gemines" in nitinol as it deforms plastically. If heat is then applied to the deformed nitinol, the cubic crystal configuration will re-align, returning the nitinol to its cold form or its memory form. This entire loading and unloading cycle is repeatable, assuming that the mechanical deformation remains within the limits of plastic deformation.
[000103] Due to the heating and cooling reactions of nitinol and the complex bonding and transformation between martensitic and austenitic structures, there are four transition temperatures for a nitinol structure: the beginning and the end of the martensitic formation within the phase austenite as the nitinol cools; and at the beginning and at the end of the austenitic formation within the fully martensite phase as the nitinol is heated. With these properties, nitinol combines many of the advantages of a metal and a plastic material in one material, allowing it to be flexibly manipulated in position with a minimum risk of corrosion.
[000104] Before surgery, staples 100 are sterilized in a solution or they are treated in a gas sterilizer for a period of time prescribed by law. The sterilization process does not alter the desired properties of the clamp 100, and can be repeated.
[000105] Alternatively, medical clamps 100 can be stored in a sterile condition in a special container (cartridge) at a temperature not exceeding 30 ° C. In the triggered (open) condition, clamp 100 is placed in a cartridge socket , designed to store one or more staples in a triggered state, for the duration of surgery until a staple 100 needs to be used.
[000106] Maintain the temperature in the cartridge during storage at no more than 30 ° C, it is necessary to ensure that the clamps of the clip 102 do not close, which occurs when the ear 101 reaches a temperature of approximately 35 ° C or above .
[000107] The maximum angle allowed for the clamps 102 to spread (as shown in Figure 1) is determined by the shape and measurements of the ear of the clamp 101. Figures 3A to 3E show a series of alternative exemplary shapes of the ear and the configurations 101a, 101b, 101c, 101d, 101e. The smaller the width of the ear 101 and the greater the total length of its profile, the greater the maximum permissible angle for the working surfaces of the clamps 105 to spread (see Figure 1).
[000108] A compression force is required to close clamp 100, this force is dependent on the size, material shape and thickness of clamp 100. Increasing the width of the ear has a greater impact on the compression force required to close clamp 100 of the than the variation in ear thickness 101.
[000109] The level of the compression force also depends on the size and shape of the ear 101. Increasing the width of the ear (more effect) or the thickness of the ear 101 can increase the level of the average compression force.
[000110] During surgery, before applying the clamp 100 to a flexible tubular organ 153, it is extracted from the cartridge, as follows.
[000111] The clip 100 is taken by your ear 101, compressing it on both sides of the work surfaces or tweezers 107/108 or 128 in contact with the elements of Peltier 110 or 129 placed on the distal ends of the tweezers 107/108 of the manipulator surgical 151 or the clamps 128 of the endoscopic manipulator 161 (depending on the type of surgery). While still holding clip 100, it is pulled out of the sterile storage cartridge in the open position.
[000112] It should be noted that the staples 100 on the cartridge are sterile and stored in the open position ready for use in an operating room. Cartridges can store multiples of a certain size, shape and style of staples or a mixture of staples needed for a given procedure.
[000113] When using surgical manipulator 151, to ensure a closed position to the upper and lower forceps 107/108 to secure the ear 101, the middle part of the forceps 107/108 is pressed by the hands of the surgeon.
[000114] It is useful to be able to set the upper clamps 107 and lower 108 of the surgical manipulator 151 in place, to allow a surgeon to move his hand, vary the pressure on the clamps 107/108, change his grip or release the surgical manipulator 151 fully. To adjust the clamps 107/108 in place, a clamping mechanism 116 can be used. The mechanism 116 comprises a slider 118 and a sliding guide 119, a plurality of guides 120 and a thrust wedge 117.
[000115] The position of the clamps 107/108 is retained by means of a clamping mechanism 116 when the sliding element 118 is moved along the guide groove 119. This movement raises the thrust wedge 117 which leads the clamps 107/108 to close.
[000116] When using the endoscopic manipulator 161, a closed position of the clamps 128 that secure the ear of the clamp 101 is achieved by the pulling rod 132 stretching when the handles (front handle 136 and rear handle 137) come together. This movement is made by the hand of the surgeon and the tight joint position can be retained through the rack mechanism 139 and its associated stop 140, which fixes the relative position of the handle 136 and 137.
[000117] A surgeon inserts the finger into the finger hole 145 and rests the index finger of the same hand on the pressure plate 141. This allows the two parts of the handle 135 to be gently pressed together, forcing the rack mechanism 139 through the hole 142. The rack mechanism 139 is connected to the rear handle 137 in a mounting groove 143 on the inner face of the rear handle 137. The rack mechanism is then inserted through hole 142 and terminated with a pressure plate 141 for the toe. surgeon rest on top. The rack stop 140 can be used to lock the clamps 128 in their current location, allowing the surgeon an opportunity to adjust his hand position handle without compromising the clamps 128 to his handle in a clamp 100.
[000118] The clamp in its cocked (open) position maintained by the manipulator 151/161 is taken to the relevant location, such as a vessel 153 intended to be tightened.
[000119] When using an endoscopic manipulator 161, a special rotation mechanism 134 allows to manipulate (rotate) the clamp 100, while it is maintained by the device (manipulator 161) and apply it to the relevant area.
[000120] The area of the organ 153 to be stapled is positioned between the work surfaces 105 of the clamps 102 (as shown in Figures 1 and 2), after which the medical clamp 100 can be applied to the area 153.
[000121] Staple 100 can be applied without placing it under plastically deforming pressure. Instead, controlled forced heating aimed above 35 ° C at the structural elements of the ear of the clamp 101. The ear 101 has no direct contact with the tight tissues 153.
[000122] The clip 100 can be applied without any mechanical load from the ear of the clip 101. A controlled heating of the ear of the clip 101 to a temperature above approximately 35 ° C is called to activate the shape memory of the ear 101 into the ear. its memory position, which is closed. The ear 101 preferably does not directly contact the tubular organ 153, as this can cause further trauma to the area through direct application of excessive heat.
[000123] Ear heating 101 is activated (started) by pressing the forced heating button 112 on surgical manipulator 151. This affects the forced heating micro-key 113. The same happens when pressing the Peltier button 146 on handle 135 of the endoscopic manipulator 161 or by pressing an appropriate forced heating pedal on a pedal device of one of the manipulators, which must be held down for approximately 0.1-10 seconds.
[000124] When pressing the buttons or other elements (to activate the heating or cooling), as mentioned above, it leads to a short (0.1-10 seconds) closing of the electrical circuit of the 121/147 power supply. As a result, the electric current of a particular polarity is applied to the light 111 and / or the audible alarm device 111, and heats the working surfaces of the elements of Peltier 110/129.
[000125] The ear of the clamp 101, which has contact with the working surfaces of the Peltier 110 elements, also heats up. When the temperature in the ear material 101 reaches above approximately 35 ° C, reactive stresses are generated as the shape memory effect occurs.
[000126] Essentially, the application of heat causes the clamp 100 to revert to its closed position, as the nitinol begins to revert to its purely austenitic cubic crystal configuration.
[000127] As a result of the memory effect of shape the ear of the clamp 101 creates a moment of force, which is transmitted to the clamps 102 of the medical clamp 100, through its arcs 103. A reciprocal movement of the clamps 102 deforms the elastic organ tubular 153, resulting under the influence of pressure on the working surface 105 of the clamps 102. Within approximately 0.1-10 seconds of forced heating of the ear, the clamp 100 is applied to the elastic tubular organ 153, closing the lumen within the organ by clamping 102 (as shown in Figure 2B).
[000128] After the clamps 102 are completely closed, the ear 101 is released to eliminate direct thermal contact between it and the working surfaces of the elements of Peltier 110/129. To do this when working with surgical manipulator 151, slider 118 is moved backward along guide groove 119, thereby releasing thrust wedge 117.
[000129] When working with the endoscopic manipulator 161, the pressure plate 141 of the rack mechanism 139 is pressed, thereby releasing it from its stop 140, which results in a rotation movement of the rear handle 137 in relation to the second connection node 138, connecting it with the front handle 136.
[000130] The compression at the place of application of the clamp to the flexible tubular organ 153 is sufficient to maintain the hemostatic effects, as the temperature of the ear 101 cools to the ambient body temperature.
[000131] If the cross-sectional area of the ear is in the range of approximately 0.1-2.0 mm2, ear 101 will be able to generate the necessary compression of approximately 0.01-5 kg or equivalent force of 0.1-50N to clip different types of organs. The variety of clamps 100 follows the anatomical classification of the vessels (small, medium, medium-large and large diameter) with their clamps 102 ranging from approximately 2 to 50 mm in length.
[000132] The suggested application of medical clamp 100 includes the presence of ear 101, and clamps 102 made in special geometric shapes (with grooves, waves, etc.), work surface 105 and arcs 103. This design provides a good lateral and longitudinal stability when applied to a tubular member 153 in that close contact with a high degree of uniformity of compression of the working surfaces 105 of the clamps 102 on the walls of a tubular body is established. The likelihood of unwanted slippage of the clamp is minimized, which can happen under pressure inside a tubular elastic organ 153 when it pulsates and / or the clamp 100 accidentally contacts surgical instruments.
[000133] The uniformity of the compression further minimizes the risk of unwanted slipping of the clamp, and works in conjunction with the undulations or teeth along the work surfaces of the clamps 105.
[000134] As a result, after clamp 100 is applied, the surgeon has an almost unlimited source of time to perform the other phases of the operation. After that, depending on the surgical treatment, for example, if the clamp is applied in the wrong place, or after completing the other stages of the operation, the blood flow can be restored.
[000135] If clamp 100 is misaligned, or needs to be adjusted or even completely removed, clamp 100 can be removed and the blood flow in vessel 153 can then be restored, naturally regenerating the vessel lumen.
[000136] Blood flow restoration is accomplished by forming a lumen within the tubular elastic organ 153. To do this, the pressure of the working surfaces 105 of the clamps 102 is reduced, as they partially open (as shown in Figure 2C ). This happens as a result of the forced cooling of the ear of the clamp 101 to a temperature below approximately 10 ° C, as the martensitic transformation is activated in the material of the ear 101.
[000137] Again, ear 101 is harvested from both sides of the working surfaces of Peltier elements, 110 or 129, placed over tweezers 107/108 of surgical manipulator 151 or tweezers 128 of endoscopic manipulator 161 (depending on the type of surgery) while moving towards each other. This movement is achieved in surgical manipulator 151 when the surgeon's hands press on the middle part of the clamps 107/108. This movement is achieved in the endoscopic manipulator 161 when the surgeon's hands tighten on the handle 135 and its rear part 137 and front 136 approach each other as the pulling rod 132 stretches.
[000138] Forced ventilation of the ear 101 is achieved when it thermomechanically contacts the working surface of the Peltier 110/129 elements. The Peltier 110/129 elements are switched to cooling mode by clicking on the forced cooling button 114 in the surgical manipulator 151, which leads to the activation of a forced cooling micro-key 115. When using the endoscopic manipulator 161 forced cooling of the ear 101 is achieved by clicking on the Peltier button 146 of the endoscopic manipulator 161 or by pressing the pedal of the device pedal control (if applicable) and then holding it down for approximately 0.1-10.0 seconds.
[000139] Pressing the 114/146 button or pedal as mentioned above leads to a quick (approximately 0.1-10.0 seconds) closing of the electrical circuit of the power supply 121 or 147. As a result, the electrical current from a Particular polarity is applied to the light 111 and / or the audible alarm device 111, and the working surfaces of the elements of Peltier 110/129 begin to cool.
[000140] Ear 101 is cooled due to thermal exchange with the cooled working surfaces of the elements of Peltier 110/129. When the temperature in the ear material 101 falls below approximately 10 ° C, martensitic transformation causes the ear material 101 to soften and the clamps 102 begin to partially open. This allows the removal of the clamp 100 from the tubular elastic organ 153 with a minimum of trauma as the pressure of the clamp 100 is reduced, being carried out (harvested) by your ear 101 and, finally, removed from the surgical wound site.
[000141] Staple 100 can be reused if treated with a sterilizing solution and / or they are treated in a gas sterilizer within the period of time prescribed by law. The clamps are then brought back to an open state with open clamps 102 ready for placement.
[000142] The proposed method for the use of these new advanced medical devices and instruments allows surgeries to have minimal traumatic effect on the tissue of the hollow tubular organs 153 of the body and provide greater precision for surgical interventions. These devices would also greatly facilitate the work of a surgeon and can shorten the duration of surgeries.
[000143] As described in this document, the Peltier elements work as a type of thermoelectric transducer or conversion element, converting the electrical potential applied between the Peltier elements into a heating or cooling effect on an external surface of the Peltier elements.
[000144] Shown in Figure 8 is a clamp manipulator 851 according to additional embodiments. The clamp manipulator 851 is similar in structure and operation to the manipulators 151 shown in Figures 4 and 5. In particular, the clamp manipulator 851 has two opposite clamps or arms 807, 808 which are flexibly deflectable from an open position in which their distal ends 809 are separated, to a closed position, in which the distal ends 809 are closed together or closed around the arms around the side areas of the base / ear part 101 of a clamp 100. The arms 807, 808 are predisposed towards the open position by their shape and by a connector 856 that couples the arms 807, 808 together at their proximal ends 826. The clamp manipulator 851 has at least one and preferably two thermoelectric transducer elements 810 ( eg Peltier elements), with each positioned at the respective distal ends 809 of the arms 807, 808 to apply a heating or cooling effect to the base / or line 101.
[000145] The 851 clamp manipulator has a power supply and an 820 switching control unit that is electrically coupled to the 810 thermoelectric transducer elements. The power supply and switching functions of the power supply and switching control unit 820 can be supplied separately from each other or within a single unit or enclosure.
[000146] The arms 807, 808 each have a part of catching 855 in a middle part of the same to facilitate the gripping and handling of the manipulator 851 during the application of the clamp. Although not shown, the arms 807, 808 can have a clamping mechanism to allow them to be held in the closed position when they are closed over a base / ear part 101 of the clamp 100.
[000147] For each embodiment of the manipulator described here, it is at the core of a manually manipulated clamp delivery device that has the functions of holding / holding and temperature change co-located at the distant end of the device. The device is therefore easily usable as a heating / cooling device (for holding and relaxing the clamp 100) and a gripping / positioning device. Although embodiments of the manipulator may, in some cases, be described with reference to the clamps or arms being elastic, this is intended to simply indicate that the clamps or the arms of the manipulator are capable of a degree of flexion and / or relative movement in a or several points along their extensions, instead of being elastic, in the sense of an elastic band. The clamps / arms of the manipulators can be formed relatively rigid, but with one or more points of articulation and / or sliding mechanisms that allow the clamps / arms to move in relation to each other in order to grab and hold the part of base / ear of clip 100.
[000148] The embodiments of the clamp described herein can be further described in the following terms. Clamp 100 may be formed wholly or in part from a shape memory alloy, such as nitinol, with at least one base part 101 being formed from the shape memory alloy. The base part 101 has a flexible central part with the opposing arms 103 which extend in a C or U shape from each side of the central part. The central part can be curved, for example, in a convex or concave shape or it can be at least partially straight, as illustrated by Figures 3A to 3E. At a minimum, the base part 101 must be configured to adopt a shape memory, when an appropriate temperature change occurs to cause the material of the base part 101 to move the opposite arms in relation to each other to adopt the shape memorized from the base 101.
[000149] The base part 101 defines lateral areas on each side of the side, where the areas point outwards in opposite directions which are generally perpendicular to a plane in which part of the base 101 curves and moves under the influence of the your shape memory. These side areas can be the flat side surfaces of the base part 101. They are areas that are intended to be attached to each side of the side of the clamp 100 by the thermoelectric transducers 110, 129 when positioning, heating or cooling the clamp 100.
[000150] Together, the base part 101 and the arms 103 preferably have a rounded C-shaped or U-shaped shape. The arms 103 extend outwardly from the base part so that they form opposite movable arms in relation to the other through an acute angle between the open and closed positions of the clamp 100. The arms 103 are coupled to the base part 101, for example, by integrally forming the arms 103 with the base part 101 or connecting them to it by adhesion, welding or mechanical coupling, for example. Although the clamp 100, as illustrated in Figure 1 suggests a possible material or mechanical transition between the base part 101 and arms / bows 103 and between the arms / bows 103 and clamps 102, they may be no material or mechanical transition where the clamp 100 is integrally formed, which is preferred. Thus, the transition can be theoretical, rather than physical.
[000151] With the base part 101 of the clamp 100 acting as a close reference point, the arms 103 extend at least a little distally, with the clamps 102 positioned at the distal ends of the arms 103. The jaws 102 are coupled to the arms 103, for example, by integrally forming the clamps 102 with the arms 103 or connecting them to it. Such connection of the clamps 102 with the arms 103 can be made by adhesion, welding or mechanical connection, for example. An outer surface and the profile of the base part 101, the arms 103 and clamps 102 can generally be smooth, optionally rounded at the proximal end and tapered to a slightly rounded point at the distal end (at least when closed).
[000152] The clamp 100 has two opposite clamps 102 that each extend towards a slightly rounded distal end of the clamp 100. The clamps 102 therefore have a distal end that corresponds to the distal end of the clamp 100 and also an inwardly extending portion functioning as an extension close to each clamp 102. Each clamp 102 defines a fabric 105 engaging surface of sufficient lateral width and surface area that does not tend to cut the fabric around which they are fixed. The tissue engaging surfaces 105 may be altered to assist in harvesting the tight tissue. The changes along the fabric 105 engaging surface can vary in amplitude, for example, increasing towards a distant tip, in order to mitigate against the possibility of the clamp sliding out of the tight tissue. The tissue 105 engaging surfaces of the clamps 102 otherwise adopt a relatively linear profile, however, for changes, in order, as far as possible, uniform compression is applied to the tight tissue when the clamp 100 is in the closed position.
[000153] Tweezers 102 have a shape tapering distally from the part where they are attached to the arms 103. However, the part that extends into each of the tweezers 102 serves to extend the tissue engaging surfaces of the tweezers 102 in one proximal direction. As shown in Figure 1, there is a space between the parts extending into the clamps 102 and the arms 103. In addition, the parts extending inwards also define a space with the base part 101. Although the parts that extend into the clamps 102 can offer a certain degree of flexion when performing a clamping or transition function between the open and closed positions, the parts of the clamps 102 that extend inwards generally do not contact the arms, the part of the base or one another. In an ideal configuration where the attached fabric is generally evenly clamped between the clamps 102 when the clamp 100 is in the closed position, the fabric engaging surfaces 105 are more or less parallel and spaced apart, as shown in Figure 2B. In such a position, the clip 100 is generally shaped like a teardrop, preferably with the base part 101 approaching a rounded larger end of the teardrop shape.
[000154] The clamp 100 is generally symmetrical around a longitudinal center line that extends through the center of the base part 101 and halfway between the clamps 102. Depending on the particular surgical application for which a clamp 100 is desired , the clamp 100 can be formed to have different dimensions. For example, the length of the clamp 100, which is its largest dimension, can be around 3 millimeters to approximately 15 to 50 millimeters, for example, with a width of 1 to 2 millimeters to approximately 5 or 10 millimeters, for example. For example, a thickness of the clamp 100 can be from approximately 1 millimeter to approximately 4 millimeters, for example.
[000155] The inwardly extending parts of the clamps 102 may have hook-like proximal parts 104 in their proximal parts further inward, effectively providing an inwardly curved end designed to avoid trapping or capturing tight tissue in an area between the part of the base 101 and the proximal ends of the parts that extend into the clamps 102. As shown in Figure 1, the parts that extend into the clamps 102 may taper slightly inward in a proximal direction until they begin to hook outwards near the base part 101.
[000156] Clamp 100 can also be considered to have a closed end, defined by the base part 101 and an open end, defined by the distal tips 106 of the clamps 102, with the clamps 102 generally defining an angle between say 0 and 45 ° in relation to each other, between the closed and open positions. Except where the clamp 100 may be too large for the fabric to be clamped or excessive clamping force is applied, the clamps 102 may generally not contact each other, in the open or closed positions. Where excessive clamping force is applied or the clamp 100 is too large for the tight tissue, the shape memory may tend to cause the clamps 102 to contact each other, towards their distal ends 106.
[000157] It is also to be noted that the clamps 102 act as the main functional component of the clamp that provides a fastening action, as needed. The arms / bows 103 and part of the base / ear 101 can thus act as a coupling part, which joins the opposing clamps 102. In this sense, the opposing clamps each have the first and second opposing ends free (ie, distal ends 106 and opposite opposite hook parts 104), with the coupling part, formed by the base part 101 and the arms 103, being coupled to each clamp 102 in an intermediate location of the opposite free ends of each clamp 102. Thus, since the coupling part 101/103 is formed of an alloy with shape memory (at least in the base part 101), the coupling part causes the relative movement of the clamps in response to a change in the temperature of the coupling part , depending on whether the temperature change that causes a cooling or heating of the shape memory activation of the metal alloy with shape memory. The relative movement of the clamps 102 is basically an increase or decrease in the angular separation between the two clamps 102. Case Study 1
[000158] Patient B, 48 years old, was admitted to a surgical department for a surgery prescribed to treat his chronic calculous cholecystitis. The patient had had the condition during the past five years, suffering several worsening approximately 5-7 times a year, when the prescribed diet was violated.
[000159] The patient was diagnosed with a gallstone disease based on his anamnesis, clinical and laboratory data and ultrasound data of the abdomen, which revealed a gallbladder so dimensioned: 8x6x5 cm, with thickened walls up to 2.3 mm, containing a large number of stones with a size of up to 3 cm.
[000160] The patient underwent laparoscopic cholecystectomy.
[000161] During surgery, the abdominal area was inspected and no other pathologies were found. The size of the gallbladder corresponded to the findings of ultrasound, that is, a dimension of 8x6x5 cm; with thickened walls and signs of chronic inflammation and the presence of multiple stones in the gallbladder. There were also adhesions around the neck and the body of the gallbladder.
[000162] The neck and body of the gallbladder were isolated from adhesions with the help of a 5 mm hook-shaped electrode. A medical clamp analogous to clamp 100 opened at a 045 ° angle made of nitinol was introduced through a 10 mm trocar into the abdominal cavity with an endoscopic handler analogous to the endoscopic handler 161. Being directly visible, the clamps they were then applied to the distal parts of a cystic conduit and a cystic artery, followed by a similar clamp application at the proximal ends of these organs. The ear was heated to more than 40 ° C and the cystic conduit and artery were blocked. As observed directly, a reliable tightening of the vessels was achieved, without any signs of leakage of blood or bile.
[000163] After removal of the gallbladder from the abdominal cavity through the trocar, the memory effect of the shape of the clamps was tested. The clamp ear was cooled below 10 ° C and the clamps opened within 1 - 2 seconds. The clamp was then easily removed from the cystic conduit and reapplied again. This feature would be very useful for the re-application and adjustment of the clamp 100 if the initial placement was not correct the first time or requires some fine adjustment for better results.
[000164] In addition, laparoscopic cholecystectomy was then completed following the standard procedure.
[000165] The post-operative recovery went without incident. The patient was discharged on day 4. Case Study 2
[000166] Patient L, 52 years old, was admitted to the surgical department for a surgery prescribed for the excision of varicose veins in both legs. Medical history of the condition was approximately 8 years. In the past 2 years, the pain in the calf muscles had increased during walking and long-distance walking. An annual hospitalization for phlebothrombosis and thrombophlebitis was also noted. Conservative treatment in the past has not been effective enough. During the analysis the blood flow within the deep veins of both lower limbs was not blocked.
[000167] Phlebotomy on the right side (removal of veins) was performed.
[000168] Surgery followed traditional methods. The distinct step was the placement of two staples analogous to staples 100 made of nitinol (nickel-titanium NiTi) over the superficial femoral vein of the hip, in the area just before this vein intersects with the deep vein. The clamp was applied to the vein with the help of the manipulator, closing the clamps, as the clamp's ear was heated above 40 ° C.
[000169] Other small and medium-sized vessels were also clamped, as the nitinol clips were placed over the proximal and distant parts of the vessels.
[000170] The wavy surface of each clamp, as well as notches present on the surface, helped to place the clamps firmly over the blood vessels. In the case of an incorrect application, the clamp can be removed by cooling the ear below 10 ° C with a handler, which would result in the clamp clamps opening and the clamp could subsequently be removed. Six veins (12 clips) were clamped during the procedure. There was no bleeding from the veins. Then, the operation followed a standard procedure.
[000171] The post-operative recovery went without incident. The patient was discharged on day 2 after surgery.
[000172] In the case studies described above, clip 100 and handlers 151, 161 proved to be a useful alternative to a standard staple to stop bleeding, for example, Autosuture and Stortz, Aesculap Mini Staples or a manual suture. The use of staples 100 significantly accelerates surgery, while the quality and reliability of the device is not inferior to mechanical clamping or a manual suture.
[000173] Much of the original description of the embodiments is contained in PCT / RU2010 / 000735 and written in the Russian language. Much of that original text is reproduced here in an English translation version. Since translations can be performed subjectively according to the translator's specialty, an alternative translation of the claims and claim language of the original document into Russian language is included in this document. This alternative translation describes embodiments, in the following terms:
[000174] Some embodiments refer to a method of obtaining hemostasis with the possible consequent restoration of blood circulation in elastic tubular body structures implemented using a clamp delivered to the target application point, by means of a manipulator support that mechanically holds the aforementioned clamp through your eye with a mechanical contact with the work surfaces of at least one Peltier thermocouple installed on the distal ends of the manipulator support branches, the method comprising the deformation of the structure of the elastic tubular body by the application of developed pressure by the clamp's closing branches, which were preliminarily separated at a temperature below the start of the martensitic transformation in the clamp's eye material in which pressure is produced by converting the moment of force to the clamp's branches through its arcs from the clamp eye the material from which it is generated m reactive stresses due to memory effect initiated by an increase in the temperature of the eye material caused by the mechanical and thermal contact of the eye material with the surfaces of the Peltier thermocouples switched to heating mode, followed by the interruption of direct contact , mechanical and thermal of the eye material with the surfaces of Peltier thermocouples while retaining a sufficient compression action to obtain hemostasis at the point of application to the elastic tubular body structures produced by the work surfaces of the clamp branches as the clamp eye is cooled to body tissue temperature, and subsequently restoring blood circulation, producing an opening in the elastic tubular body structures due to the reduction in pressure developed by the work surfaces of the clamp branches and its partial opening as the clamp eye is cooled even below the start transfection temperature martensitic formation of the clamp eye material due to the mechanical and thermal contact of the eye material with the working surfaces of the Peltier thermocouple placed in cooling mode.
[000175] Preliminary opening of the clamp branches can be achieved at a temperature below 20 ° C. Shape memory effect on the clamp eye material can occur above 35 ° C for 0.1 - 10 s. Complete or partial restoration of blood circulation is achieved by producing an opening in the structures of the elastic tubular body. Partial opening of the clamp branches to restore blood circulation can be achieved at a temperature below 20 ° C for 0.1 - 10 s.
[000176] Some embodiments refer to a medical clamp made of a biologically inert material compatible with living tissues comprising an eye the ends of which are connected with two branches by means of two arches, in which the proximal ends of the branches, are located in the space between the arcs of the clamp, and at least the eye of said medical clamp is made of a shape memory material.
[000177] The eye of the aforementioned medical clamp is made of titanium - nickel medical alloy. The eye of said medical clamp can have a variety of shapes, for example, a semicircular, ellipsoidal, U-shaped or zigzag shape. The maximum permissible opening angle and the average compression force of the medical clamp can be determined by the shape and size of the medical clamp's eye. The proximal ends of the branches can be located in the space between the arches of the clamp and the eye of the clamp. Both branches of said medical clamp can have the same or different lengths ranging from 50 mm to 50 mm. Said branches can have variable or constant thickness through their length.
[000178] All or part of the work surfaces of the branches can have a uniform and smooth profile, or wavy and smooth, or uniform and rough, or wavy and rough. All or part of the work surfaces of said medical clamp can have straight or oblique slits. All or part of the work surfaces of said medical clamp have straight or oblique grooves. The length of the arches of the medical clamp does not exceed the length of the respective branches of the clamp, and the thickness and width of said arches of the medical clamp can be determined by the thickness and width of the eye. The distribution profile of the compression force across the length of said branches of the medical clamp is determined by the variable size of the clamp arches and the connection point of the clamp arch to said branches.
[000179] Some embodiments refer to a surgical manipulator support comprising elastic branches at the top and bottom located along one another with a space between them and connected at their proximal ends, in which the surface of at least the distal parts of said elastic branches at the top and bottom is made of biologically inert material, the lateral dimensions of said elastic branches at the top and bottom are smaller than their longitudinal sizes, and the distal end of at least one branch has Peltier thermocouples connected by means of conductive and electrically insulated wires running along said branches to a power unit having at least one three-way Peltier thermocouple switch box.
[000180] The distal ends of said elastic branches at the top and bottom can be connected to each other by means of screws, welding, soldering or gluing. The lateral sizes of said elastic branches at the top and bottom can vary through the length of the branch. Peltier thermocouples can be connected using solder or screws.
[000181] The power unit can be a source of direct or alternating current. The Peltier thermocouple switch box can be in the form of a forced heating button and forced cooling button provided in the middle parts of one of the said branches, opposite to which a forced heating micro-key and a cooling micro-key forced are supplied in the other branch and are connected to said unit of force installed in the distal part of said branch of the upper part. The Peltier thermocouple switch box can be in the form of a foot switch, having a power unit and connected to said surgical manipulator support via an electrical connector provided at the distal ends of said upper and lower branches.
[000182] The middle part of said surgical manipulator support may have a branched clamp comprising a slider, a stop key rigidly connected to said upper branch and which passes freely through an opening in said lower branch, the sliding control directs and a guide groove in said upper branch in which said slider directs are provided and rigidly fixed to its lower part. The surgical manipulator support may have visible light and / or audible alarms.
[000183] Some embodiments refer to an endoscopic manipulator support comprising two elastic branches, at least one of which is mobile, in which said elastic branches are provided at the distal end of said manipulator support, and their surfaces are made of a biologically inert material, the free end of at least one branch has Peltier thermocouples connected via electrically conductive wires running inside a hollow elastic pin that has a rotation mechanism installed between the proximal end of said pin and a handpiece, for a power unit that has at least one three-way Peltier thermocouple switch box, the other ends of said elastic branches intersect at the first connection unit provided at the distal end of said hollow elastic pin and connected to a traction rod running through of said hollow elastic pin and mobilely connected with the rear loop of said handpiece that is movably connected with the front handle of said handpiece through the second connection unit, and the rear handle of said handpiece has a connection point for a rack operating through a opening in the front handle of said handpiece the other end of which has a pressure plate.
[000184] The rotation mechanism can be connected with the upper part of the said front handle.
[000185] Said front handle has an opening for the finger. The mobile connection between said pull rod and said rear handle can be achieved by means of a fixing socket, provided at the top of said rear handle above the second connection unit to which the head of said pull rod is attached. . The three-way Peltier thermocouple switch box can be in the form of forced heating and cooling micro switches provided in said front or rear handles and connected to a power unit provided in said handpiece. The Peltier thermocouple switch box can alternatively be in the form of a foot switch, having a power unit and connected to said endoscopic manipulator support via an electrical connector provided in said handpiece. The support of the endoscopic manipulator may have visible light and / or audible alarms.
[000186] It will be appreciated by persons skilled in the art that numerous modifications and variations can be made in the embodiments described above, without departing from the broad and general scope of the present disclosure. The present embodiments should, therefore, be considered in all respects as illustrative and not restrictive.

权利要求:
Claims (15)
[0001]
1. Clamp comprising: a base part (101); opposing first and second arms (107, 108) coupled to the base part (101); and opposing first and second clamps (102) coupled to the respective first and second arms (107, 108), the opposite first and second clamps (102) each having an inward extension part that extends towards the base part ( 101) when the clamps are in an open position; wherein at least the base part (101) is formed of a memory alloy so that it tends to force the first and second arms towards each other and towards the closed position when the temperature of the base part (101 ) reaches or exceeds a transformation temperature of the base part (101); characterized by the fact that each clamp comprises an internal tissue engaging surface and the engaging surfaces of the calipers are parallel and opposite to each other when the calipers are in a closed position.
[0002]
2. Clamp according to claim 1, characterized by the fact that the part extending into each of the opposite first and second clamps (102) has an internal end that curves towards the respective first and second arms ( 107, 108).
[0003]
Clamp according to claim 1 or 2, characterized in that an external surface of the clamp along the base part (101) and the opposing first and second arms (107, 108) is smooth.
[0004]
Clamp according to any one of claims 1 to 3, characterized in that the clamp is formed from biologically inert materials and is a surgical clamp.
[0005]
Clamp according to any one of claims 1 to 4, characterized in that the first and second clamps (102) each have extreme parts extending out of the base part (101), and the extreme parts having rounded tips.
[0006]
6. Clamp according to any one of claims 1 to 5, characterized in that the first and second clamps (102) are separable to adopt an open position in which the clamps (102) are sharply angled in relation to each other .
[0007]
7. Clamp according to claim 6, characterized by the fact that when a shape memory of the base part (101) is activated by heating the base part (101), the base part (101) tends to force the first and second clamps (102) towards a closed position.
[0008]
8. Clamp according to claim 7, characterized in that in the closed position, the inwardly extending parts do not contact each other.
[0009]
Clamp according to any one of claims 1 to 8, characterized in that at least one of: at least the base part (101) is formed of nitinol; the base part (101), the arms (107, 108) and the clamps (102) comprise the same material; the base part (101), the arms (107, 108) and the clamps (102) are integrally formed.
[0010]
10. Clamp according to any one of claims 1 to 9, characterized in that the first and second clamps (102) have changes formed along at least a part of a straight internal capture surface.
[0011]
11. Clamp according to any one of claims 1 to 10, characterized in that the base part (101) defines at least one region for contact with a temperature modifying element, wherein the at least one region comprises regions opposite and the clamp can be maintained for surgical application when pressing the opposite regions.
[0012]
12. Cartridge characterized in that it comprises a plurality of clips as defined in any one of claims 1 to 11.
[0013]
13. Cartridge according to claim 12, characterized in that the plurality of clamps is maintained on the cartridge in an open position.
[0014]
Kit characterized in that it comprises at least one of the staples as defined in any one of claims 1 to 11 or the cartridge as defined in claim 12 or 13 and which further includes a staple manipulator (851), the staple manipulator (851) comprising: at least one arm (807, 808) to hold a clamp, and at least one thermoelectric transducer (810) to transmit a change in temperature to the base part (101) of the clamp sufficient to make the temperature of the base part ( 101) reach or exceed the transformation temperature.
[0015]
Kit according to claim 14, characterized in that at least one arm (807, 808) of the clamp manipulator (851) comprises a distal pair of clamps (102) arranged with a thermoelectric transducer (810) in each clamp, in which the opposite clamps (102) are usable to simultaneously press the base part (101) of the clamp and thereby transmit the temperature change.

类似技术:

---

公开号 | 公开日 | 专利标题

---

JP6396401B2|2018-09-26|Manipulator for surgical clip

---

US10524791B2|2020-01-07|Left atrial appendage devices and methods

---

JP5638522B2|2014-12-10|Apparatus and method for placing a closure fastener

---

WO2005046453A2|2005-05-26|Left atrial appendage devices and methods

---

CA3027376C|2022-02-15|Surgical clip and clip manipulation device therefor

---

RU2240735C1|2004-11-27|Clip for obturating hollow extended organs

同族专利:

---

公开号 | 公开日

---

KR102024194B1|2019-11-04|

---

EP2648627A1|2013-10-16|

---

RU2485908C2|2013-06-27|

---

JP2014504185A|2014-02-20|

---

JP6396401B2|2018-09-26|

---

CA3027376A1|2012-06-14|

---

EP2648627B1|2017-03-29|

---

CN103370017B|2016-12-14|

---

US10064623B2|2018-09-04|

---

CN103370017A|2013-10-23|

---

US11246596B2|2022-02-15|

---

US20180344321A1|2018-12-06|

---

KR101906438B1|2018-12-07|

---

AU2018211231B2|2019-10-03|

---

EP2648627A4|2015-09-02|

---

CN106974703A|2017-07-25|

---

KR20140008320A|2014-01-21|

---

CA2856747A1|2012-06-14|

---

JP2019022668A|2019-02-14|

---

EA031268B1|2018-12-28|

---

AU2011340795A1|2013-06-27|

---

US20140058411A1|2014-02-27|

---

AU2016238955B2|2018-06-14|

---

KR20180112108A|2018-10-11|

---

KR20190108197A|2019-09-23|

---

CN106974703B|2020-10-13|

---

JP6549770B2|2019-07-24|

---

WO2012075532A1|2012-06-14|

---

KR102224353B1|2021-03-09|

---

BR112013014075A2|2016-11-22|

---

WO2012078067A1|2012-06-14|

---

EA201891702A3|2019-05-31|

---

AU2011340795B2|2016-07-07|

---

JP6067574B2|2017-01-25|

---

CA2856747C|2019-02-05|

---

JP2017077492A|2017-04-27|

---

EA201500951A1|2016-03-31|

---

EA201891702A2|2018-12-28|

---

AU2016238955A1|2016-11-03|

---

EA036862B1|2020-12-29|

---

EA023456B1|2016-06-30|

---

EA201390831A1|2013-11-29|

---

AU2018211231A1|2018-08-16|

引用文献:

---

公开号 | 申请日 | 公开日 | 申请人 | 专利标题

---

---

SU58667A1|1938-08-27|1939-11-30|В.Г. Поляков|Tweezers|

---

US3120230A|1960-10-24|1964-02-04|Jack H Sanders|Surgical clamp|

---

DE2123703C3|1970-05-20|1979-01-25|Codman & Shurtleff, Inc., Randolph, Mass. |Blood vessel clamp holder and associated blood vessel clamp|

---

US3867944A|1972-10-27|1975-02-25|Wood Ernest C|Hemostatic clip and applicator therefor|

---

US3980861A|1973-03-26|1976-09-14|Akio Fukunaga|Electrically heated miniature thermal implement|

---

DE2730691C2|1976-07-16|1982-12-16|Maruho Co. Ltd., Osaka|Surgical clip, connecting element for several surgical clips and forceps for opening and closing the same|

---

SU640618A1|1976-10-01|1995-06-19|Институт Радиотехники И Электроники Ан Ссср|Bistable switch with storage|

---

US4485816A|1981-06-25|1984-12-04|Alchemia|Shape-memory surgical staple apparatus and method for use in surgical suturing|

---

US4586503A|1983-12-01|1986-05-06|University Of New Mexico|Surgical microclip|

---

JPS61143049A|1984-12-17|1986-06-30|Sendai Mech Kogyo Kk|Medical fluid stopping instrument|

---

US4805618A|1985-08-08|1989-02-21|Olympus Optical Co., Ltd.|Oviduct closing apparatus|

---

JPS63288147A|1987-05-21|1988-11-25|Olympus Optical Co Ltd|Clip device|

---

US4834096A|1987-10-26|1989-05-30|Edward Weck Incorporated|Plastic ligating clips|

---

US5022126A|1990-04-13|1991-06-11|Edward Weck Incorporated|One-piece plastic towel clamp|

---

FR2668361B1|1990-10-30|1995-04-21|Christian Mai|

---

US5171252A|1991-02-05|1992-12-15|Friedland Thomas W|Surgical fastening clip formed of a shape memory alloy, a method of making such a clip and a method of using such a clip|

---

RU2032384C1|1991-07-08|1995-04-10|Георгий Цыренович Дамбаев|Clamp for soft tissues|

---

US5171251A|1992-03-02|1992-12-15|Ethicon, Inc.|Surgical clip having hole therein and method of anchoring suture|

---

US5250046A|1992-03-26|1993-10-05|Lee Curtis O|Heated forceps|

---

JPH0647048A|1992-06-04|1994-02-22|Olympus Optical Co Ltd|Ligature and suture device|

---

US5392917A|1993-08-03|1995-02-28|Ethicon, Inc.|Easy open 1-2-3 instrumentation package|

---

RU2052979C1|1994-03-22|1996-01-27|Товарищество с ограниченной ответственностью "Дипы" ЛТД|Apparatus for application of clamping clips and magazine for suturing staples or clamping clips|

---

FR2756767A1|1996-12-06|1998-06-12|Andromis Sa|SHAPE MEMORY MATERIAL GRIPPING DEVICE AND METHOD OF MAKING SAME|

---

RU2128012C1|1998-03-11|1999-03-27|Оспанов Орал Базарбаевич|Compression anastomosis apparatus|

---

GB9827415D0|1998-12-11|1999-02-03|Wild Andrew M|Surgical apparatus and method for occluding a body passageway|

---

AU5924099A|1998-12-31|2000-07-24|Jeffrey E. Yeung|Tissue fastening devices and delivery means|

---

US6193732B1|1999-01-08|2001-02-27|Cardiothoracic System|Surgical clips and apparatus and method for clip placement|

---

US6896684B2|2000-06-12|2005-05-24|Niti Medical Technologies Ltd.|Surgical clip applicator device|

---

US6746461B2|2000-08-15|2004-06-08|William R. Fry|Low-profile, shape-memory surgical occluder|

---

US6322580B1|2000-09-01|2001-11-27|Angiolink Corporation|Wound site management and wound closure device|

---

US6547783B1|2000-10-24|2003-04-15|Enduratec Systems Corp.|Thermo-electric grip for holding soft tissue|

---

US20020111641A1|2001-01-08|2002-08-15|Incisive Surgical, Inc.|Bioabsorbable surgical clip with engageable expansion structure|

---

RU2213529C2|2001-09-26|2003-10-10|Московский государственный институт стали и сплавов |Method and clip for clipping blood vessels, soft flexible structures and fixing tissues|

---

US7094245B2|2001-10-05|2006-08-22|Scimed Life Systems, Inc.|Device and method for through the scope endoscopic hemostatic clipping|

---

JP4237626B2|2001-10-24|2009-03-11|ボストンサイエンティフィックリミテッド|Multiple hemoclip system for endoscope|

---

US20030225423A1|2002-05-30|2003-12-04|Huitema Thomas W.|Surgical clip|

---

US6638297B1|2002-05-30|2003-10-28|Ethicon Endo-Surgery, Inc.|Surgical staple|

---

US7112214B2|2002-06-25|2006-09-26|Incisive Surgical, Inc.|Dynamic bioabsorbable fastener for use in wound closure|

---

GB0305976D0|2003-03-14|2003-04-23|Wild Andrew M|Surgical clip|

---

US20040193189A1|2003-03-25|2004-09-30|Kortenbach Juergen A.|Passive surgical clip|

---

RU2241391C1|2003-04-22|2004-12-10|Дамбаев Георгий Цыренович|Device for creating laparoscopic anastomoses|

---

US7179254B2|2004-03-09|2007-02-20|Ethicon, Inc.|High intensity ablation device|

---

RU2275870C2|2004-03-29|2006-05-10|Иван Геннадьевич Заговеньев|Clip for creating choledochoduodenal anastomosis|

---

US8152834B2|2005-04-13|2012-04-10|Synthes Usa, Llc|Forceps and system using same|

---

RU2294689C2|2005-05-18|2007-03-10|Юрий Ильич Гурфинкель|Device for non-invasive monitoring of dynamic characteristics of capillaries and capillary blood flow|

---

EP1747761B1|2005-07-28|2009-10-14|Covidien AG|An electrode assembly with electrode cooling element for an electrosurgical instrument|

---

US20070088412A1|2005-10-13|2007-04-19|Intelifuse, Inc., A Corporation Of The State Of Delaware|System and device for heating or cooling shape memory surgical devices|

---

US7892244B2|2006-03-09|2011-02-22|Niti Surgical Solutions Ltd.|Surgical compression clips|

---

US20080147092A1|2006-10-23|2008-06-19|Michael Rogge|Hybrid energy instrument combined with clip application capability|

---

DK2211768T3|2007-10-11|2021-06-28|Implantica Patent Ltd|FLOW CONTROL DEVICE IN A BODY ORGAN|

---

US8585717B2|2008-08-29|2013-11-19|Covidien Lp|Single stroke endoscopic surgical clip applier|

---

FR2938422A1|2008-11-17|2010-05-21|Pierre Sarradon|VASCULAR ANASTOMOSIS CLIPS AND METHOD OF APPLICATION|

---

JP5401088B2|2008-12-09|2014-01-29|株式会社アドバネクス|clip|

---

EP2398548B1|2009-02-17|2017-04-19|The Board Of Trustees Of The Leland|Closure device|

---

JP5290813B2|2009-03-06|2013-09-18|株式会社トップ|forceps|

---

DE102009018820A1|2009-04-24|2010-10-28|Aesculap Ag|Magazine with a variety of C-shaped ligature clips|

---

CN201519174U|2009-09-24|2010-07-07|杭州康基医疗器械有限公司|Blood clamp for clamping and closing human body blood vessels|

---

CN101897611A|2010-07-08|2010-12-01|山东大学|Intrusion type inverted titanium clips and use method thereof|

---

US9486220B2|2011-09-28|2016-11-08|Covidien Lp|Surgical tissue occluding device|US8652202B2|2008-08-22|2014-02-18|Edwards Lifesciences Corporation|Prosthetic heart valve and delivery apparatus|

---

EP2768399B1|2011-10-20|2017-12-06|Teleflex Life Sciences Unlimited Company|Ligation clip|

---

US9901351B2|2012-11-21|2018-02-27|Atricure, Inc.|Occlusion clip|

---

DE102013004652B4|2013-03-16|2014-10-30|Zahoransky Ag|Device for producing surgical clips bent from wire sections|

---

EP3071122B1|2013-11-21|2021-08-11|AtriCure Inc.|Occlusion clip|

---

CN103690201B|2014-01-13|2016-09-14|天津医科大学总医院|Treadle type endoscope biopsy system and using method thereof|

---

CN111437068A|2014-12-04|2020-07-24|爱德华兹生命科学公司|Percutaneous clamp for repairing heart valve|

---

US9901352B2|2014-12-12|2018-02-27|Atricure, Inc.|Occlusion clip|

---

EP3294219B1|2015-05-14|2020-05-13|Edwards Lifesciences Corporation|Heart valve sealing devices and delivery devices therefor|

---

US20170014135A1|2015-07-14|2017-01-19|Keith Edward Martin|Surgical tool|

---

CN112971975A|2015-12-03|2021-06-18|波士顿科学国际有限公司|Electric knife hemostatic clamp|

---

US10799676B2|2016-03-21|2020-10-13|Edwards Lifesciences Corporation|Multi-direction steerable handles for steering catheters|

---

US10799675B2|2016-03-21|2020-10-13|Edwards Lifesciences Corporation|Cam controlled multi-direction steerable handles|

---

US11219746B2|2016-03-21|2022-01-11|Edwards Lifesciences Corporation|Multi-direction steerable handles for steering catheters|

---

US10835714B2|2016-03-21|2020-11-17|Edwards Lifesciences Corporation|Multi-direction steerable handles for steering catheters|

---

US10799677B2|2016-03-21|2020-10-13|Edwards Lifesciences Corporation|Multi-direction steerable handles for steering catheters|

---

CN105997184B|2016-06-12|2018-02-23|杨西群|Delivery device for the Ni-based marmem anal fistula internal orifice closure folder of titanium|

---

ITUA20164730A1|2016-06-28|2017-12-28|Promev S R L|SUTURE DEVICE|

---

RU2623313C1|2016-07-05|2017-06-23|Федеральное государственное автономное образовательное учреждение высшего образования "Национальный исследовательский Томский государственный университет" |Device for phacofragmentation|

---

US10973638B2|2016-07-07|2021-04-13|Edwards Lifesciences Corporation|Device and method for treating vascular insufficiency|

---

AU2017305440B2|2016-08-03|2019-11-07|Teleflex Medical Incorporated|Surgical ligation clip|

---

US10653862B2|2016-11-07|2020-05-19|Edwards Lifesciences Corporation|Apparatus for the introduction and manipulation of multiple telescoping catheters|

---

US10905554B2|2017-01-05|2021-02-02|Edwards Lifesciences Corporation|Heart valve coaptation device|

---

WO2018175626A1|2017-03-21|2018-09-27|Teleflex Medical Incorporated|Clip applier with stabilizing member|

---

US20180271532A1|2017-03-21|2018-09-27|Teleflex Medical Incorporated|Surgical clip and clip applier|

---

WO2018175605A1|2017-03-21|2018-09-27|Teleflex Medical Incorporated|Clip applier with replaceable tips|

---

US11266408B2|2017-03-21|2022-03-08|Teleflex Medical Incorporated|Clip applier having stabilizing member|

---

US11224511B2|2017-04-18|2022-01-18|Edwards Lifesciences Corporation|Heart valve sealing devices and delivery devices therefor|

---

JP2020516364A|2017-04-18|2020-06-11|エドワーズ ライフサイエンシーズ コーポレイションＥｄｗａｒｄｓ Ｌｉｆｅｓｃｉｅｎｃｅｓ Ｃｏｒｐｏｒａｔｉｏｎ|Heart valve sealing device and delivery device thereof|

---

US10799312B2|2017-04-28|2020-10-13|Edwards Lifesciences Corporation|Medical device stabilizing apparatus and method of use|

---

US10959846B2|2017-05-10|2021-03-30|Edwards Lifesciences Corporation|Mitral valve spacer device|

---

CA3068282A1|2017-06-22|2018-12-27|Teleflex Medical Incorporated|Surgical clip|

---

US11051940B2|2017-09-07|2021-07-06|Edwards Lifesciences Corporation|Prosthetic spacer device for heart valve|

---

US11065117B2|2017-09-08|2021-07-20|Edwards Lifesciences Corporation|Axisymmetric adjustable device for treating mitral regurgitation|

---

US11040174B2|2017-09-19|2021-06-22|Edwards Lifesciences Corporation|Multi-direction steerable handles for steering catheters|

---

US20190133590A1|2017-11-03|2019-05-09|Covidien Lp|Ligation clip with controlled tissue compression|

---

CN108042169B|2017-12-21|2020-03-10|吴再义|Operation ligature forceps|

---

US10076415B1|2018-01-09|2018-09-18|Edwards Lifesciences Corporation|Native valve repair devices and procedures|

---

US10231837B1|2018-01-09|2019-03-19|Edwards Lifesciences Corporation|Native valve repair devices and procedures|

---

US10973639B2|2018-01-09|2021-04-13|Edwards Lifesciences Corporation|Native valve repair devices and procedures|

---

US10238493B1|2018-01-09|2019-03-26|Edwards Lifesciences Corporation|Native valve repair devices and procedures|

---

US10159570B1|2018-01-09|2018-12-25|Edwards Lifesciences Corporation|Native valve repair devices and procedures|

---

US10507109B2|2018-01-09|2019-12-17|Edwards Lifesciences Corporation|Native valve repair devices and procedures|

---

US10123873B1|2018-01-09|2018-11-13|Edwards Lifesciences Corporation|Native valve repair devices and procedures|

---

US10105222B1|2018-01-09|2018-10-23|Edwards Lifesciences Corporation|Native valve repair devices and procedures|

---

US10136993B1|2018-01-09|2018-11-27|Edwards Lifesciences Corporation|Native valve repair devices and procedures|

---

US11207181B2|2018-04-18|2021-12-28|Edwards Lifesciences Corporation|Heart valve sealing devices and delivery devices therefor|

---

GB2576007A|2018-07-31|2020-02-05|Minks Wendy|A nose clamp|

---

US10945844B2|2018-10-10|2021-03-16|Edwards Lifesciences Corporation|Heart valve sealing devices and delivery devices therefor|

---

KR102240609B1|2018-12-04|2021-04-15|최교창|surgical clip|

---

CN110236634A|2019-07-30|2019-09-17|上海理工大学|The separable hemostasis clamp device of memorial alloy formula|

---

WO2022010464A1|2020-07-08|2022-01-13|A2 Medical Systems LLC|Ligation clips with anti-migration features|

---

CN112264943B|2020-09-09|2021-06-08|北京理工大学|Bionic micro clamp based on vascularization spiral artificial muscle drive|

法律状态:
2018-01-30| B25A| Requested transfer of rights approved|Owner name: GLOBETEK 2000 PTY LTD (AU) , THE FEDERAL STATE AUT |

---

2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

---

2019-09-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

---

2020-07-21| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|

---

2020-11-17| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

---

2021-02-23| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 07/12/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

---

申请号 | 申请日 | 专利标题

---

RUPCT/RU2010/000735|2010-12-07|

---

PCT/RU2010/000735|WO2012078067A1|2010-12-07|2010-12-07|Method of a hemostasis creation with restoration possibility of blood- flow in tubular elastic structures of an organism and device for its realization|

---

PCT/AU2011/001586|WO2012075532A1|2010-12-07|2011-12-07|Surgical clip and clip manipulation device therefor|

---