巴西专利BR112013008751B1 MEDICAL SYSTEM FOR HITTING TISSUE

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专利摘要:
medical devices with detachable rotating jaws are medical systems, devices and methods for engaging tissue, for example, for joining tissue, closing a perforation or performing hemostasis. in general, the medical system includes a housing, first and second rotating jaws with respect to the housing, a driver and an elongated drive wire. the elongated drive wire can be disconnected from the driver, the first and second jaws and the housing, which are left hooked in vivo to the tissue.
公开号:BR112013008751B1
申请号:R112013008751-0
申请日:2011-10-11
公开日:2021-04-27
发明作者:Michelle D. Martinez；Vihar C. Surti；Tyler Evans Mclawhorn
申请人:Cook Medical Technologies Llc；
IPC主号:

专利说明:

BACKGROUND
[001] Conventionally, a clip can be inserted into a body cavity through an endoscope to secure living tissue in a body cavity for hemostasis, marking and / or ligation. Such clips are often known as surgical clips, endoscopic clips, hemostatic clips and vascular clips. In addition, the clips are now being used in various applications related to gastrointestinal bleeding such as peptic ulcers, Mallory-Weiss lacerations, Dieulafoy lesions, angiomas, post-papillary bleeding and small varicose veins with active bleeding. Attempts have been made to use the clips to close stomach perforations.
[002] Gastrointestinal bleeding is a serious and somehow common condition that is often fatal if left untreated. This problem has motivated the development of several endoscopic therapeutic approaches to achieve hemostasis, such as the injection of sclerosing agents and contact thermocoagulation techniques. Although such approaches are often effective, bleeding continues for many patients and corrective surgery is therefore necessary. Due to the fact that surgery is an invasive technique that is associated with a high rate of morbidity and many other undesirable side effects, there is a need for less invasive, highly effective procedures.
[003] Mechanical hemostatic devices such as clips have been used in various parts of the body, including gastrointestinal applications. One of the problems associated with conventional hemostatic clips and devices, however, is that many devices are not strong enough to cause permanent hemostasis. Additionally, there have been attempts to use clips to close perforations in gastrointestinal and stomach structures, but unfortunately, traditional clips suffer from difficult placement and the ability to hold a limited amount of tissue, which potentially results in incomplete closure. SUMMARY
[004] The invention may include any of the following aspects in various combinations and may include any other aspect described below in the written description or in the accompanying drawings.
[005] In a first aspect, a medical device is provided to engage a tissue, the medical device including a housing, first and second jaws, a driver and a driving wire and an elongated tubular member. The housing defines an internal passage and a longitudinal geometric axis that extend between proximal and distal ends of the housing. The first and second jaws are rotatable in relation to the housing and have proximal and distal ends. The driver is engaged with the proximal ends of the first and second jaws, in which the longitudinal movement of the driver rotates the first and second jaws in relation to the housing. The elongated drive wire is selectively connected to the driver for longitudinal movement with it and the drive wire has an enlarged portion close to a distal end of the drive wire. The elongated tubular member defines a lumen dimensioned to receive a connection block slidably. The connection block defines a hole that slidably receives the drive wire, in which the enlarged portion of the drive wire has a dimension that is larger than the hole and is positioned on a distal side of the connection block. The connection block is operable between an extended position and a retracted position. The connection block protrudes from the tubular member in the extended position and is structured to engage a proximal end of the housing. The connection block is positioned inside the lumen of the tubular member in the retracted position and disengaged from the housing. The enlarged portion of the drive wire engages the connection block by proximal retraction of the drive wire to operate the tubular member from its extended position to its retracted position and disengage the connection block from the housing.
[006] According to additional detailed aspects, the connection block is preferably dimensioned to engage the housing by friction. The connection block may include a connection ring that has a plurality of tabs, wherein the housing includes a plurality of slits that extend to a proximal end of the housing that receives the plurality of tabs. The plurality of slits may each include a narrowed throat that separates the proximal and distal portions of the slits. The housing may additionally include a plurality of grooves formed therein, the grooves being each connected to a distal portion of the slits to improve the flexibility of the housing. The connection block includes a distal flange and a proximal flange that define a portion of reduced diameter between them and in which the tubular member includes one between a pin and a flap that protrudes into the lumen and positioned within the portion of reduced diameter to limit the longitudinal movement of the connection block. The connection block may also include a compressible member attached to it and dimensioned to be compressed between an interior of the housing and an exterior of the connection block.
[007] According to additional detailed aspects, the system can also include a fixation member fixed to a distal end of the tubular member, the fixation member including a passage in communication with the lumen of the tubular member. The fixing member preferably includes diametrically opposed openings between the ends of the fixing member in communication with the passage. The connection block includes a distal flange and a proximal flange that define a portion of reduced diameter between them and in which the fixing member preferably includes at least one flap that protrudes into the lumen and positioned within the portion of reduced diameter to limit the longitudinal movement of the connection block, the flap formed in a unitary and integral way with the fixing member. The system may also include a locking pin that has a bifurcated stake defined by two teeth that have a gap between them. The slot is dimensioned to receive the drive wire in it and the bifurcated pile is dimensioned to pass through the opposite opening in the fixing member and limit the longitudinal movement of the connection block. The system can additionally include, still, an applicator that has a left body slidably attached to a right body, the left and right body including dimensioned and molded channels to receive portions of the tubular member and fixation member and maintain its position with respect to the applicator. The channels are further dimensioned and shaped to receive parts of the locking pin, thus the relative translation of the left and right body positions the forked peg of the locking pin into or out of the opposite openings in the fixing member. Alternatively, the applicator may simply have a main body and a bifurcated stake that protrudes from the main body, with the bifurcated stake defined by two teeth having a gap between them, the gap being dimensioned to receive the wire. drive in it, and the bifurcated pile is dimensioned to pass through the opposite opening in the fixing member and limit the longitudinal movement of the connection block.
[008] According to yet further detailed aspects, an enlarged portion of the actuation wire is an enlarged distal head and the actuator includes a socket proximally turned and that receives the distal head. The driver is constructed of a resilient material that flexes to adjust the size of the socket. The socket is dimensioned to selectively receive the enlarged distal head of the drive wire. A locking tab can be positioned on a socket inlet and moves to vary the size of the inlet. Preferably, the driver includes two locking tabs on opposite sides of the socket and the housing includes a guide surface that guides the longitudinal movement of the driver, the guide surface including two surfaces on opposite sides of the housing corresponding to the locking tabs. The housing can further define a shoulder in the transition between the proximal and distal part of the guide surface, where the locking tabs are positioned to engage the shoulder to limit the longitudinal movement of the actuator. The shoulder preferably deflects the flap to a position in engagement with the shoulder when a longitudinal force directed distally on the actuator reaches a predetermined force to allow the longitudinal movement of the actuator and the first and second jaws in a distal direction. BRIEF DESCRIPTION OF THE DRAWINGS
[009] The accompanying drawings incorporated in and forming a part of the specification illustrate various aspects of the present invention and together with the description serve to explain the principles of the invention. In the drawings:
[010] Figure 1 is a top view of a medical system that has a medical device for engaging a tissue, constructed in accordance with the teachings of the present invention;
[011] Figure 2 is a top view similar to Figure 1, but showing the outer structures in dotted lines and the inner sections in solid lines and partial cross section;
[012] Figure 3 is a side view of the medical system and device shown in Figure 1;
[013] Figure 4 is a side view similar to Figure 3, but showing the outer structures in dotted lines and the inner structures in solid lines and partial cross section.
[014] Figure 5 is a side view of a medical device that is part of the medical system represented in Figures 1 to 4;
[015] Figure 6 is a front view of a housing that forms a portion of the medical system and device shown in Figures 1 to 5;
[016] Figure 7 is a perspective view of the housing shown in Figure 6;
[017] Figures 8 to 12 are side views showing the operation of the medical system and device represented in Figures 1 to 5;
[018] Figures 13 and 14 are top views, partially in cross section, representing the operation of the medical system and device represented in Figures 1 to 4;
[019] Figures 15 and 16 are seen in cross section showing the operation of the medical system and device represented in Figures 1 to 4.
[020] Figure 17 is a perspective view of an alternative embodiment of a connection block that forms a portion of the medical system of Figure 1;
[021] Figure 18 is an anterior view showing the connection block of Figure 17;
[022] Figure 19 is a perspective view of an alternative embodiment of the housing that forms a portion of the medical system and medical device of Figure 1;
[023] Figures 20 to 22 show stages of operation of the medical system represented in Figures 17 to 19;
[024] Figure 23 is a perspective view of another alternative embodiment of a portion of the medical system and medical device represented in Figure 1;
[025] Figure 24 is seen in perspective of another modality of the medical system represented in Figure 1
[026] Figure 25 is a side view of the medical system represented in Figure 24;
[027] Figure 26 is a perspective view of a locking pin that forms a portion of the medical system represented in Figures 21 to 25;
[028] Figures 27 to 28 are seen in perspective showing the operation of an applicator for the locking pin shown in Figure 26; and
[029] Figure 29 is a perspective view of an alternative modality of the applicator represented in Figures 27 to 28. DETAILED DESCRIPTION OF THE INVENTION
[030] The terms "proximal" and "distal" as used in this document are intended to have a point of reference in relation to the user. Specifically, throughout the specification, the terms "distal" and "distally" must denote a position, direction, or orientation that is generally distant from the user and the terms "proximal" and "proximally" must denote a position, direction, or orientation which is usually towards the user.
[031] An exemplary medical system 20 that has a medical device 40 for engaging a T tissue (Figure 11) is shown in Figures 1 to 4. The medical system 20 and device 40 are generally dimensioned and structured for operation through the delivery channel. work of an endoscope (not shown) or other scope, although system 20 and device 40 can still be used alone or in conjunction with other elongated devices such as catheters, fiber optic visualization systems, needles and the like. Generally, the medical system 20 includes a drive wire 22 slidably housed within the distal end 23 of an elongated catheter 24 for selective connection to, and operation of, the medical device 40. As will be described in further detail herein, the medical device 40 generally includes a housing 42 that has a first jaw 44 and a second jaw 46 pivotally connected thereto to engage the T tissue. Generally, the jaws 44, 46 have been shown to form forceps to clamp, although the jaws are intended to be used to hold tissue, for example, to close an opening or for hemostasis. Accordingly, it will be recognized that the shape and structure of the jaws can take many forms and serve many purposes and functions, all in accordance with the teachings of the present invention.
[032] In medical system 20, the drive wire 22 extends slidably through catheter 24. Although the term "wire" is used to refer to drive wire 22, it will be recognized that any elongated control member that has the ability to transmit longitudinal force over a distance (as required in endoscopic, laparoscopic and similar procedures) can be used, and that includes plastic tubes or rods, single filament or multifilament yarns and the like. A connection block 26 is slidably fitted within the distal end 23 of the catheter 24 and defines a hole 28 through which the drive wire 22 slidably receives. The exterior of the connection block 26 includes a recessed portion 27, and two pins 30 (for example, formed from stainless steel wire) are connected to catheter 24 and positioned within the recessed portion 27 to limit the longitudinal movement of the connection block 26.
[033] A distal end of the drive wire 22 defines a distal head 32 which is dimensioned larger than the drive wire 22, and likewise larger than the hole 28 in the connection block 26. As will be described later in the present document, the distal head 32 is used to slide the connection block 26 into the catheter 24 to disconnect the medical device 40 from the medical system 20. As seen further in Figures 1 to 4, the housing 42 of the medical device 40 is a tubular member which defines an interior space 43. A proximal end of the housing 42 receives by friction a distal end of the connection block 26 within the interior space 43 for selective connection therewith.
[034] The internal passage 43 of the housing 42 also receives the first and second jaws 44, 46 and a driver 48 which is used to interconnect the drive wire 22 to the jaws 44, 46. As best seen in Figures 1, 2 and 5, the driver 48 has a proximal portion that defines a socket 50 sized to receive the enlarged distal head 32 of the drive wire 22. At the proximal entrance of the socket 50, the two flexible locking tabs 52 are formed which rotate with respect to the remainder of driver 48 to increase or decrease the size of socket 50. Locking tabs 52 can be formed separately and pivotally attached to driver 48, or they can be formed integrally with driver 48 and formed of a resistant material that flexes to allow rotation of the locking tabs 52 radially inward and radially outward. Preferably, the locking tabs 52 are plastically deformable, so that they can be locked to the drive wire 22 or to the housing 42, as further discussed in this document.
[035] A distal portion of the actuator 48 defines a shelf 54 for engaging and operating the jaws 44, 46. In the embodiment shown, the shelf 54 includes a central spine 56 that has teeth 58 that project away from the central spine 56 and on sides opposites of the spine 56. One set of teeth 58 on one side of the spine 56 generally operates the first jaw 44 while the other set of teeth 58 on the other side of the spine 56 operates the second jaw 46. It will be recognized that the shelf 54 may include a single set of teeth or other meshed structures that interfaces with the jaws 44, 46.
[036] As best seen in Figure 5, the first and second jaws 44, 46 include distal ends 60, 62 that are structured to hold and engage the tissue, generally, they have a jaw shape as revealed in document 61 / 141,934 deposited on December 31, 2008, the disclosure of which is incorporated in this document as a reference in its entirety. The proximal ends 64, 66 of the first and second jaws 44, 46 each include a pinion gear 68, 70 which has a series of teeth. The teeth of the pinion 68, 70 intertwine with the teeth of the shelf 54 of the driver 48 so that the longitudinal translation of the driver 48 induces rotation in the first and second jaws 44, 46 with respect to each other. Generally, the distal translation of the driver 48 causes the first and second jaws 44, 46 to rotate outwardly apart, while the proximal retraction of the driver 48 causes the first and second jaws 44, 46 to rotate inward. towards each other. The pins 80 are adjusted through each of the proximal ends of the jaws 44, 46, to swivel the jaws to the housing 42. Other structures for forming a swivel connection can be used, and preferably the swivel connection is arranged centrally in in relation to pinions 68, 70.
[037] In addition to the jaws 44, 46 which are pivotally attached to the housing 42, the first and second jaws 44, 46 are also slidably attached to the housing 42. As best seen in Figures 6 and 7 (and together with Figures 1 to 4) the housing 42 defines a first guide surface 82 for the first jaw 44, and a second guide surface 84 for the second jaw 46. As seen in Figure 3, the first and second guide surfaces 82, 84 are formed by elongated slits 82a, 82b, 84a, 84b formed on opposite sides of the housing 42 which leaves a thickness of the housing 42 exposed to serve as the guide surface. The slots 82a, 82b are aligned to receive the connector pin 80 of the first jaw 44, and likewise the slots 84a, 84b are aligned to receive the connector pin 80 of the second jaw 46. The ends of the slits, for example, the ends distal 92, 94 shown in Figure 7, serve to restrict the longitudinal movement of the jaws 44, 46 in relation to the housing 42. The proximal ends 64, 66 of the jaws 44, 46 include holes 72, 74 that receive pins 80 (Figures 1 , 2 and 3) which are used to swivel and slide the first and second jaws 44, 46 to the housing 42.
[038] It can also be seen in Figures 6 and 7 that the housing 42 defines a third guide surface 86 that guides the longitudinal movement of the driver 48 within the housing 42. The guide surface 86 in the embodiment shown includes a left guide surface 86a and a right guide surface 86b formed as C-shaped channels. As shown in Figure 7, the third guide surface 86 transitions from a smaller proximal width to a larger distal width to define a shoulder 88 in the transition, which will be described further in this document below with reference to Figures 13 and 14.
[039] As further shown in Figure 6, the internal passage 43 of the housing 42 extends through the distal end of the housing, and through it the first and second jaws 44, 46 can extend. Additionally, as shown in Figures 1 and 2, the housing 42 defines opposite slots 45 which are sized to allow the first and second jaws 44, 46 to pass through them when they rotate radially outward. Accordingly, it is also clear from Figures 1 and 2 that housing 42 serves to block rotation of the first and second jaws 44, 46 when they are contained entirely or partially within the internal passage 43 of housing 42. Plastics suitable for forming the housing include, but are not limited to, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (EPTFE), polyethylene ether ketone (PEEK), polyvinyl chloride (PVC), polycarbonate (PC), polyamide, polyimide, polyurethane, polyethylene (density high, medium or low), and suitable metals include stainless steel, nitinol and alloys and metals of similar medical grade.
[040] The operation of the medical device 40 will now be described with reference to Figures 8 to 12. As shown in Figure 8, the first and second jaws 44, 46 are shown in a retracted position where they are contained substantially within the housing 42. Depending on the application, the distal ends 60, 62 of the jaws 44, 46 may protrude slightly from the distal end of the housing 42 in their retracted positions, or they may be positioned entirely within the housing 42. When the drive wire 22 is translated distally (on the right in the page in Figure 8) the distal head 32 engages the driver 48 and since the shelf 54 of the driver 48 is interwoven with the pinions 68, 70 at the proximal ends 64, 60 of the jaws 44, 46, the driver 48 and the jaws 44, 46 slide distally through the housing 42 because the housing 42 blocks their rotation. As mentioned earlier, this longitudinal movement is guided by the first and second guide surfaces 82, 84 which receive the pins 80 that swivel and slide the jaws 44, 46 to the housing 42.
[041] As shown in Figure 9, the first and second jaws 44, 46 have an extended position in which the jaws project substantially from a distal end of housing 42, and the proximal ends 64, 66 of them are positioned adjacent to the distal end of housing 42. Accordingly, it will be observed that the further distal advance of the drive wire 22 and therefore of the driver 48, causes the pinion 68 to rotate on the teeth 58 of the shelf 54. As best seen in Figure 10, the first and second jaws 44, 46 rotate radially outward from each other in a tissue receiving position. Notably, due to the presence of slits 45 at the distal end of the housing 42, the jaws 44, 46 are allowed to rotate through a full 90 °, thus forming at least a 180 ° between them. It will be recognized that by dimensioning the slits 45 and the construction of the shelf 54 and pinions 68, 70, the first and second jaws 44, 46 can rotate even further apart.
[042] In the fabric receiving the configuration shown in Figure 10, the medical device 40 and jaws 44, 46 thereof can be positioned adjacent to the T fabric. As shown in Figure 11, the T fabric can be placed between the first and the second jaws 44, 46 and jaws 44, 46 rotated back towards their position shown in Figure 9. T tissue has been shown as a single layer, although multiple layers can be trapped between jaws 44, 46. Generally, proximal retraction of the drive wire 22 and the driver 48 again causes the first and second jaws 44, 46 to rotate to secure the T fabric between them. As shown in Figure 12, the additional proximal retraction of the drive wire 22 and driver 48 will cause the jaws 44, 46 to move longitudinally in a proximal direction (left on the page in Figure 12).
[043] In order for the medical device 40 to serve as a clip and hold the mandible of the same in the T tissue, or to hold two layers of tissue against each other, the jaws 44, 46 can be locked in position and the drive wire 22 of the medical system 20 disconnected from the medical device 40. As shown in Figure 13, the third guide surface 86 (which guides the driver 48) includes a proximal portion 86p and a distal portion 86d. The proximal portion 86p of the third guide surface 86 has a width (measured above and below the page in Figure 13) that is greater than a width of the distal portion 86d of the third guide 86. As previously discussed, the third guide surface 86 is formed opposing C-shaped surfaces or channels 86a, 86b of the housing 42. The transition between the proximal portion 86p and the distal portion 86d defines a shoulder 88, and in particular two shoulders 88a, 88b on opposite sides of the housing 42. The shoulders 88a, 88b are dimensioned and positioned to engage the locking tabs 52 located on the driver 48.
[044] As shown in Figure 13, when the driver 48 is located within the distal portion 86d of the third guide surface 86, the locking tabs 52 are forced radially inwardly engaged by firm friction with the drive wire 22. Indicated by otherwise, the socket 50 formed by the driver 48 to receive the distal head 32 has an entrance that is narrowed by the deflection into the locking tabs 52. In this state shown in Figure 13, the drive wire 22 is firmly engaged with the driver 48 and, consequently, the first and second jaws 44, 46. When the drive wire 22 and driver 48 are retracted proximally, for example, by means of the fabric mandible as shown in Figure 12, the proximal end of the driver 48 is received within the proximal portion 86p of the third guide surface 86 which has a greater width which allows the radial movement outward of the locking tabs 52. Accordingly, in the state it represents shown in Figure 14, the locking tabs 52 can be loosely and detachably connected to the distal head 32 of the drive wire 22. That is, the proximal retraction of the jaws 44, 46 will be limited by the T fabric that engages the distal end of the housing 42, or the pins 80 will touch the proximal ends of the slots 82a, 82b, 84a, 84b that define a first and second guide surfaces 82, 84. As such, when the proximal movement of the jaws 44, 46 and the driver 48 thus limited, the additional proximal movement of the drive wire 22 and the distal head 32 thereof can be used to remove the distal head 32 from socket 50 of the driver 48. This operation can also be used to further deflect the locking tabs 52 radially outward, for example, by means of plastic deformation in that outward position to maintain the closed configuration of the jaws. In the event that the natural elasticity of the T fabric tends to pull the jaws 44, 46 out of the housing towards their extended position, the locking tabs 52, 54 will touch the shoulders 88a, 88b of the third surface housing guide 42 to prevent additional distal movement of the jaws 44, 46.
[045] Turning now to Figures 15 and 16, by means of an even more proximal retraction of the drive wire 22 and distal head 32, the enlarged distal head 32 will lean against the connection block 26 which is slidably adjusted inside. from the distal end 23 of the catheter 24. Sufficient proximal force in the drive wire 22 will overcome the friction fit between the connection block 26 and the proximal end of the housing 42, thus moving the connection block 26 proximally (right on the page of Figures 15 and 16) to retract the connection block 26 into the tubular connector 24, as shown in Figure 16. The catheter 24 can be used to provide a counter force in the housing 42 while proximally retracting the drive wire 22 and connection block 26. Accordingly, the drive wire 22, the catheter 24 and the connection block 26 can be completely disconnected from the medical device 40, thereby leaving the first and second jaws 44, 46 and the housing 42 in a state that has T tissue trapped between jaws 44, 46 and retained in vivo. The connection block 26 is retained at the distal end 24 of the catheter 24 by means of the pins 30, which are positioned within the recessed area 27 to engage the proximal and distal ends of the connection block 26 and limit its longitudinal movement.
[046] The elongated catheter 24 (or another elongated tubular member such as the liner, tube, scope or the like), which slidably covers the drive wire 22, extends proximally along it to a proximal end of the system 20 , and has a length suitable for placing the device 40 at any desired location within the body, while the proximal ends of the drive wire 22 and the catheter 24 are positioned outside the body for use by the medical professional. Handling controls (not shown) for controlling the relative translation of the drive wire 22 and catheter 24 are well known in the art and can be used at the proximal end of the system 20.
[047] In another embodiment of a medical system 120 shown in Figures 17 to 22, a connection block 126 is slidably assisted within the distal end 23 of catheter 24 (Figures 20 to 22) and defines a hole 128 through it (Figure 18) that slidably receives the drive wire 22. As best seen in Figures 17 to 18, the exterior of the connection block 126 includes a reduced portion 127 that defines a proximal flange 132 and a distal flange 134. In this embodiment , the distal flange 134 is larger than the proximal flange 132 (longitudinally), and it is slightly smaller than an inner diameter of the tubular housing 142 of the clip device 140 (i.e., it does not have a friction fit). Here, a connection ring 136 is attached to the distal flange 134 and includes a plurality of tabs 138 that project radially outwardly and connect to housing 142.
[048] As best seen in Figure 19, the proximal end of housing 142 includes a plurality of slots 144 that correspond to flaps 138 of connection ring 136. Slots 144 extend longitudinally from the end surface of housing 142 and include a narrowed region or throat 146 which is sized to retain the flaps 138 in a distal portion of the slits 144. A plurality of slots 148 can be formed in the housing 142 at the ends of the slits 144 to provide additional flexibility to allow the slits 144 to slightly increase as the flaps 138 pass through the grooves 146 of the slits 144. The housing 142 can be formed of a suitable metal or plastic (or combination thereof) that is sufficiently flexible for the passage of the flaps 138 in the slits 144, while still being rigid the enough to form the guide surfaces that guide the jaws and driver as previously described. As shown in the sequence of Figures 20 to 22, the connection block is initially positioned within the proximal end of the housing 142 so that the flaps 138 are blocked in the distal portions of the slits 144 and held in position by the throat 146. When the wire drive 22 and the distal head 32 thereof are retracted proximally to engage connection block 126 (see, for example, Figures 15 to 16), connection block 126 is moved proximally to housing 142 so that the flaps 138 move through the necks 146 and into the proximal portions of the slits 144, as shown in Figure 21. With the additional proximal movement of the drive wire 22 and / or catheter 24, the clip device 40 can be disengaged from catheter 24 and drive wire 22, as shown in Figure 22.
[049] In yet another embodiment of a connection block 226 for a medical system 220, shown in Figure 23, block 226 again includes a bore 228 and a reduced portion 227 defined by a proximal flange 232 and a distal flange 234. In this embodiment, the distal flange 234 is provided with an O-ring 234 or other similar gasket or compressible member (for example, a disc or individual flaps made of an elastomer or rubber) that is fitted on the outside of the distal flange 234. The connection 226 may include a groove for receiving the O-ring 234, or it may be fixed by means of friction adjustment, adhesives, connection techniques such as plastic welding, or other mechanical connection structures. The O-ring 234 is dimensioned to provide a friction fit between the connection block and the proximal end 244 of the housing 242. The proximal end 244 can also be formed with a chamfer 246 or another inclined surface to guide the interconnection of the block. connection 226 and housing 242.
[050] It will be recognized by those skilled in the art that the drive wire 22 and the distal head 32 of the same can be connected again to the driver 48 and socket 50 of the same, which thus allows additional manipulation of the medical device to fit the connected tissue T. Likewise, additional medical devices can be attached to the drive wire 22 and tubular connector 24 of the medical system 20 for installation of the additional medical devices, for example, the multiple devices 40 for joining the tissue T can be used to close a perforation or achieve hemostasis. Generally, the support ring 34 (Figures 1 to 4) attached to the drive wire 22 can be used to limit the distal movement of the drive wire 22 and can be advanced distally to a position that abuts the connection block 26. As such , the drive wire 22 and the support ring 34 can be used to push the connection block 26 distally out of the tubular connector 24 so that it can be attached to the housing (eg 42) of a new medical device (for example, 40), or the medical device 40 previously placed. Alternatively, the user can manually press (ie with fingers or a tool) the connection block 26 distally out of the tubular connector 24 for connection with another medical device.
[051] Figures 24 to 29 represent the various alternative devices and modalities that facilitate the loading of a clip device 40 into the medical system 20 in accordance with the aforementioned document. In Figure 24, a catheter fixation 330 takes the form of a tubular member that defines an inner passage 332 that extends through it. The proximal end 331 of the catheter fixation 330 is sized to be connected to the distal end of the catheter 24, as shown in Figure 25 (for example, through friction adjustment, adhesives, welding or plastic bonding, mechanical connectors, etc.) . The catheter fixation 330 includes a pair of diametrically opposed openings 334 that provide access to the control wire 22 that runs through the catheter 24 and the passage 332, as best seen in Figure 25. The catheter fixation 330 also includes cutouts in the shape of a U 336 in four places, the cutouts 336 that leave the flaps 338. The flaps 338 can be curved radially inward as shown in Figure 25 and can thus be used to replace pin 30 on catheter 24 shown in previous embodiments. That is, the flaps 338 protrude in the passage 332 and fit within the reduced portion 127 of the connection plug 126 as described with reference to Figures 17 to 22. Like the pin 30, the flaps 338 limit the longitudinal movement of the block connection 126, while allowing the rotation of the connected block 126 and the control wire 22 and the catheter 24.
[052] The large openings 334 in the catheter fixation 330 provide access to hold the connection block 126 in an extended position for fixing another clip device 40. Returning to Figure 26, a locking pin 350 is shown which can be positioned through the openings 334 and the catheter fixation 330 for maintaining the connection block 126 in the extended position thereof shown in Figure 25. The locking pin 350 includes a main body 352 that has a flange 354 that projects laterally from the same. From the flange 354, a forked pile 356 is projected which still projects laterally from the main body 352. The forked pile 356 includes two teeth 358 that are separated to define a 360 gap between them. The slot 360 is sized to receive the drive wire 22 in it and is further separated to be placed completely through the openings 334 in the catheter fixation 330. In this way, the locking pin 350 prevents the proximal movement of the connection block 126 to keep it in place for fixing another device 40 for joining the fabric.
[053] Figures 27 and 28 represent an applicator 400 for placing locking pin 350 through opening 334 in the catheter fixation 330. Applicator 400 generally includes a left body 402 and a right body 404, each of which define openings 406, 408 for receiving fingers from a medical professional. The left and right bodies 402, 404 are slidably connected to each other, for example, using a plurality of rods 410 projecting from the left body 402 which are received slidably within passages 412 formed on the right body 404. The left and right body 402, 404 also include channels for receiving catheter 24 and fixing catheter 30 for placing locking pin 350. In particular, the channels include a lower portion 414 which is sized to receive the catheter 24 and an upper portion 416 which is dimensioned to receive the catheter fixation 330. The upper channel portions 416 also include depressions that receive the locking pin 350 and in particular, the left body 402 includes a recess 418a for receiving the main body 352 and flange 354 of the locking pin 350, while the right body 404 includes a recess 418b for receiving the ends of the teeth 358 of the locking pin 350. Accordingly age and as shown in Figure 28, the distal end of the catheter 24 and the catheter fixation of the same 330 can be loaded into channels 414, 416, of the right body 404, and then the left body 402 can be moved to engage with the body right 404 so that the locking pin 350 is placed through the openings 334 in the catheter fixation 330 so that the teeth 358 extend around the control wire 22 and the proximal movement of the connection block 126 is prevented, which it thus allows the housing 42, 142 of a clip device 40, 140 to be pressed into the connection block 26, 126, 226.
[054] Finally, Figure 29 represents a perspective view of another modality of an application 500 for maintaining the connection block 26, 126, 226 in an extended position. As with the embodiment of Figures 24 to 28, catheter 24 includes catheter fixation 330 as previously described. Here, applicator 500 is a single gripping member 502 that has recesses 504 on opposite sides for gripping between the two fingers of the medical professional. The recesses 504 open to one side of the body 502, while the opposite side includes a forked pile 556 that has two separate teeth 558 to define a slot 560. As with the previous embodiment, teeth 558 are sized to be passed through the openings 334 in the catheter fixation 330 so that the drive wire 22 is received inside the slot 560, through which the proximal movement of the connection block 126 is blocked to maintain its extended position for fixing another device 40 for joining the tissue .
[055] The additional modalities of the connection / disconnection mechanisms and the medical system 20 can be found in the Copending Order document No. US 61 / 391.875 and Order No. 61 / 391.881, the disclosures of which are incorporated in this document to reference title in its entirety.
[056] The foregoing description of various embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise revealed modalities. Various modifications or variations are possible in light of the above teachings. The modalities discussed were chosen and described to provide the best illustration of the principles of the invention and the practical application of them, thereby enabling an individual of ordinary skill in the art to use the invention in various modalities and with various modifications as appropriate to the private use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the extent to which they are entitled in a correct, legal and fair manner.

权利要求:
Claims (17)
[0001]
1. Medical system (20; 120; 220) for engaging tissue (T), the medical system (20; 120; 220) comprising: a housing (42; 142; 242) that defines an internal passage (43) and an axis longitudinal geometric that extends between the proximal and distal ends of the housing (42; 142; 242); a first mandible (44) rotatable with respect to the housing (42), the first mandible (44) having proximal and distal ends (64, 60); a second mandible (46) rotatable with respect to the housing (42), the second mandible (46) having proximal and distal ends (66, 62); a driver (48) attached to the proximal ends (64, 66) of the first and second jaws (44, 46), the longitudinal movement of the driver (48) rotating the first and second jaws (44, 46) with respect to housing (42); an elongated drive wire (22) selectively connected to the driver (48) for longitudinal movement with it, the drive wire (22) having an enlarged portion close to a distal end of the drive wire (22); and a tubular member (24) that defines a lumen; characterized by the fact that the lumen is dimensioned to receive slidingly a connection block (26; 126; 226), and the connection block (26; 126; 226) defines a hole (28; 128; 228) that the drive wire (22) slidably receives, the enlarged portion of the drive wire (22) having a size that is larger than the hole (28; 128; 228) and positioned on a distal side of the connection block (26; 126; 226); and the connection block (26; 126; 226) operable between an extended position and a retracted position, the connection block (26; 126; 226) protruding from the tubular member (24) in the extended position and structured to engage a proximal end of the housing (42; 142; 242), the connection block (26; 126; 226) positioned within the lumen of the tubular member (24) in the retracted position and disengaged from the housing (42; 142; 242 ), in which the enlarged portion of the drive wire (22) engages the connection block (26; 126; 226) by proximal retraction of the drive wire (22) to operate the tubular member (24) from its extended position to its retracted position and disengages the connection block (26; 126; 226) from the housing (42; 142; 242).
[0002]
2. Medical system (20), according to claim 1, characterized by the fact that the connection block (26) is dimensioned to engage by friction to the housing (42).
[0003]
Medical system (120) according to claim 1, characterized in that the connection block (126) includes a connection ring (136) which has a plurality of tabs (138), and in which the housing (142) includes a plurality of slits (144) extending to a proximal end of the housing (142) receiving the plurality of tabs (138).
[0004]
Medical system (120) according to claim 3, characterized in that the plurality of slits (144) each includes a narrowed throat (146) that separates the proximal and distal portions of the slits (144) .
[0005]
5. Medical system (120) according to claim 3, characterized by the fact that the housing (142) further includes a plurality of grooves (148) formed in it, with the grooves (148) each being connected to a distal portion of the slits (144) to improve the flexibility of the housing (142).
[0006]
6. Medical system (120) according to claim 1, characterized by the fact that the connection block (126) includes a distal flange (134) and a proximal flange (132) that define a reduced diameter portion (127 ) between them and where the tubular member (24) includes one of a pin (30) and a flap (338) that protrudes into the lumen and positioned within the reduced diameter portion (127) to limit the longitudinal movement of the connection block (126).
[0007]
Medical system (220) according to claim 1, characterized in that the connection block (226) includes a compressible member (234) fixed to it and sized to be compressed between an interior of the housing (242) and an exterior of the connection block (226).
[0008]
8. Medical system (120), according to claim 1, characterized by the fact that it also comprises a fixation member (330) fixed to a distal end of the tubular member (24), the fixation member ( 330) includes a passageway (332) in communication with the lumen of the tubular member (24).
[0009]
Medical system (120) according to claim 8, characterized in that the fixing member (330) includes diametrically opposed openings (334) between the ends of the fixing member (330) in communication with the passage ( 332).
[0010]
10. Medical system (120) according to claim 8, characterized in that the connection block (126) includes a distal flange (134) and a proximal flange (132) that define a reduced diameter portion (127 ) between them, and in which the fixing member (330) includes at least one flap (338) that protrudes into the lumen and positioned within the reduced diameter portion (127) to limit the longitudinal movement of the connection block ( 126), the flap (338) being formed in a unitary and integral way with the fixing member (330).
[0011]
11. Medical system (120), according to claim 9, characterized by the fact that it also comprises a locking pin (350) that has a bifurcated stake (356) defined by two teeth (358) that have a slot (360) between them, the slit (360) is dimensioned to receive the drive wire (22) in it, and the forked pile (356) is dimensioned to pass through the opposite opening (334) in the member of (330) and limit the longitudinal movement of the connection block (126).
[0012]
Medical system (120), according to claim 11, characterized by the fact that it also comprises an applicator (400) that has a left body (402) slidably attached to a right body (404), being that the left and right bodies (402, 404) include channels dimensioned and molded to receive portions of the tubular member (24) and fixation member (330) and maintain their position in relation to the applicator (400), with the channels still being dimensioned and molded to receive parts of the locking pin (350), thus the relative translation of the left and right bodies (402, 404) positions the forked pile (356) of the locking pin (350) into or out of the opposite openings ( 334) on the fixing member (330).
[0013]
13. Medical system (120), according to claim 12, characterized by the fact that the left and right bodies (402, 404) each include openings (406, 408) sized to receive fingers from a medical professional .
[0014]
14. Medical system (120), according to claim 9, characterized by the fact that it also comprises an applicator (500) that has a main body (502) and a bifurcated stake (556) that protrudes from the main body (502), with the bifurcated pile (556) defined by two teeth (558) having a slot (560) between them, and the slot (560) is dimensioned to receive the drive wire (22) in the same, with the bifurcated pile (556) being dimensioned to pass through the opposite opening (334) in the fixing member (330) and limit the longitudinal movement of the connection block (126).
[0015]
Medical system (120) according to claim 14, characterized in that the main body (502) includes recesses (504) on opposite sides of the main body (502), the recesses (504) being dimensioned to receive the fingers of a medical professional.
[0016]
16. Medical system (20) according to claim 1, characterized by the fact that the enlarged portion of the drive wire (22) is an enlarged distal head (32), and in which the driver (48) includes a socket (50) turned proximally, the actuator (48) is constructed of a resilient material that flexes to adjust the size of the socket (50), and the socket (50) is sized to selectively receive the enlarged distal head (32) of the drive wire (22).
[0017]
17. Medical system (20) according to claim 16, characterized by the fact that the driver (48) includes two locking tabs (52) on opposite sides of the socket (50), and in which the housing (42) includes a guide surface (86) that guides the longitudinal movement of the driver (48), the guide surface (86) including two surfaces (86a, 86b) on opposite sides of the housing (42) corresponding to the two locking tabs (52), and where the housing (42) defines a shoulder (88) at the transition between the proximal and distal part of the guide surface (86), and where the locking tabs (52) are positioned to engage the shoulder (88) to limit the longitudinal movement of the driver (48).

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同族专利:

公开号 | 公开日

JP5676772B2|2015-02-25|

AU2011316687B2|2014-10-30|

CN103228223A|2013-07-31|

US8939997B2|2015-01-27|

EP2627264B1|2015-06-17|

WO2012051191A2|2012-04-19|

EP2939610A1|2015-11-04|

JP2015091352A|2015-05-14|

EP2939610B1|2018-11-28|

CN106073843A|2016-11-09|

EP2627264A2|2013-08-21|

US20120109160A1|2012-05-03|

JP5934332B2|2016-06-15|

BR112013008751A2|2020-09-01|

AU2011316687A1|2013-05-02|

CN106073843B|2019-05-17|

US20150100070A1|2015-04-09|

US9955977B2|2018-05-01|

CN103228223B|2016-07-06|

US11129624B2|2021-09-28|

JP2013544127A|2013-12-12|

US20180193021A1|2018-07-12|

DK2627264T3|2015-09-07|

WO2012051191A3|2012-08-02|

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法律状态:
2020-09-15| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2021-03-16| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2021-04-27| 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 11/10/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

US39187810P| true| 2010-10-11|2010-10-11|

US61/391,878|2010-10-11|

US12/971,873|2010-12-17|

US12/971,873|US8771293B2|2009-12-22|2010-12-17|Medical devices with detachable pivotable jaws|

PCT/US2011/055786|WO2012051191A2|2010-10-11|2011-10-11|Medical devices with detachable pivotable jaws|

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