Crimping device and loading tool for crimping device

Abstract

An apparatus for crimping one or more suture fasteners to one or more corresponding surgical sutures is disclosed. The apparatus further includes: at least one shaft having one or more receiving surfaces; one or more anvils; one or more hammers; one or more pushers movable in a direction substantially parallel to a longitudinal axis of the at least one shaft and configured to engage at least one of the hammer and the anvil to advance the hammer and the anvil together; and a loading tool. The loading tool may also include a target housing defining one or more snare guides, a target tray coupled to the target housing, one or more suture fasteners, one or more snare loops, and at least one handle.

Description

[0001] Related applications

[0002] This international patent application claims priority to U.S. Provisional Patent Application No. 62 / 838,250, filed on April 24, 2019, entitled “CRIMPING INSTRUMENT AND LOADING TOOL THEREFOR.” The entire contents of the 62 / 838,250 application are incorporated herein by reference. Technical Field

[0003] The claimed invention relates generally to surgical instruments for crimping cannulas to secure sutures, and more particularly to such surgical instruments having a loading tool therefor. Background Art

[0004] LSI Solutions is a registered trademark of and The marketed ductile suture fasteners, such as sleeves, are a significant improvement over hand or instrument knotting in laparoscopic surgery. Made of a ductile material, such as titanium, which has been shown to be safe during prolonged exposure to body tissue, the sleeves slide over two or more suture strands and deform or crimp to secure the multiple strands.

[0005] An exemplary crimping instrument is shown in U.S. Patent No. 7,235,086, entitled "CRIMPING INSTRUMENT WITH MOTION LIMITING FEATURE," assigned to LSI Solutions, Inc., of Victor, New York. Using this device, the end of a suture can be passed through a crimping sleeve held between a hammer and anvil in the end of the device. The suture end passes through a hole in the side of the shaft, and the device can be used to position the crimping sleeve at a desired location on the suture relative to the surface through which the suture has been secured (e.g., tissue, a replacement anatomical structure such as a heart valve, or an augmented anatomical structure such as a heart valve annulus).

[0006] The actuator advances a wedge located in the shaft and forces a hammer into the crimping sleeve. The hammer presses the crimping sleeve against the anvil, and the suture is securely held by the deformed sleeve. A blade may also be incorporated into the shaft and simultaneously moved by the actuator to trim the suture ends.

[0007] Such devices for attaching suture fasteners have proven to be very effective. and Device (information available at www.lsisolutions.comThe use of an automatic knotting and cutting device is shortening aortic cross-clamp times in minimally invasive mitral valve surgery.

[0008] and Devices like these enable the performance of various types of minimally invasive surgery (MIS), or more specifically, minimally invasive cardiac surgery (MICS). MIS is a procedure performed through one or more small incisions or access sites created within the patient's body. Compared to traditional approaches, MIS has been shown to have at least equivalent morbidity and mortality outcomes, with reported advantages of reduced postoperative pain, improved respiratory function, shorter hospital stays, and improved cosmetic outcomes.

[0009] Typically, for something like The device's crimping instrument provides a quick-loading unit to facilitate loading a crimpable sleeve into the device, followed by threading of the suture through the crimpable sleeve held by the device. While this works well for a single crimpable fastener when used with a pair of suture ends, it is not suitable for use with multiple sets of suture ends, especially when gauze is involved. This situation is further complicated by the need for a crimping device capable of handling multiple crimpable fasteners simultaneously.

[0010] Therefore, there is a need not only for a surgical crimping instrument capable of simultaneously placing multiple crimpable fasteners, but also for a loading tool for the surgical crimping instrument that is compatible with multiple sets of suture ends, multiple crimpable fasteners, and the inherent suture management requirements that arise from such use, particularly when gauze is involved. Furthermore, there is a need for such a loader, whether separate from or integrated with the crimping instrument, that is simple and easy to use. Summary of the Invention

[0011] An apparatus for crimping one or more suture fasteners to one or more corresponding surgical sutures is disclosed. The apparatus further comprises: at least one shaft; one or more receiving surfaces, each receiving surface being configured to receive one of the one or more suture fasteners; one or more anvils, each of the one or more anvils corresponding to one of the one or more receiving surfaces; one or more hammers, each of the one or more hammers corresponding to one of the one or more anvils and capable of moving relative to its corresponding anvil to crimp the one or more suture fasteners therebetween and received in the one or more receiving surfaces; one or more pushers capable of moving in a direction substantially parallel to the longitudinal axis of the at least one shaft and configured to engage the hammer and the at least one of the anvils to advance the hammer and the anvil together; and a loading tool, which may include: a target mask that defines one or more snare guides; a target tray that is coupled to the target mask; one or more suture fasteners, each of the one or more suture fasteners being located within a corresponding one of the one or more receiving surfaces of the instrument; one or more snare loops, each snare loop surrounding a corresponding one of the one or more snare guides; and at least one handle that is coupled to the one or more snare loops such that movement of the at least one handle draws the one or more snare loops coupled to the at least one handle through the one or more suture fasteners.

[0012] Also disclosed is a loading tool for a crimping instrument. The loading tool further includes: a target mask defining one or more snare guides; a target tray coupled to the target mask; one or more suture fasteners; one or more snare loops, each snare loop surrounding a corresponding one of the one or more snare guides; and at least one handle coupled to the one or more snare loops such that movement of the at least one handle relative to the one or more suture fasteners draws the one or more snare loops coupled to the at least one handle through the one or more suture fasteners. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1A is an upper right distal perspective view of one embodiment of an instrument for crimping suture fasteners with one embodiment of a loading tool.

[0014] Figure 1B yes Figure 1A Lower right distal perspective view of the crimping instrument and loading tool.

[0015] Figure 2A 、 2B, 2C, 2D, 2E and 2F are from Figure 1A Top, left, right, bottom, distal, and close-up views of one embodiment of a target mask for a loading tool.

[0016] Figure 3A 、 3B , 3C, 3D, 3E and 3F are from Figure 1A Top, left, right, bottom, distant, and close-up views of one embodiment of a target tray of a loading tool.

[0017] Figures 4A-4P is a series of exploded views showing the assembly of one embodiment of a crimping apparatus with a loading tool. Note that Figures 4I and 4O are absent to avoid possible confusion with similar looking figures.

[0018] Figures 5A-5H One embodiment of an example use of an embodiment of a loading tool to load suture into a crimping instrument is shown.

[0019] Figures 6A-6C is a partially exploded view illustrating another embodiment of a loading tool for a surgical crimping instrument.

[0020] Figure 7 Yet another embodiment of a loading tool for a surgical crimping instrument is shown.

[0021] It will be appreciated that for purposes of clarity and where considered appropriate, reference numerals have been repeated in the drawings to indicate corresponding features and that elements in the drawings have not necessarily been drawn to scale so as to better illustrate the features. DETAILED DESCRIPTION

[0022] Figure 1A is an upper right distal perspective view of one embodiment of an instrument 20 for crimping suture fasteners having one embodiment of a loading tool 22 . Figure 1B yes Figure 1A 20 and the loading tool 22. The loading tool 22 has a target cover 24 and a target tray 26.

[0023] In this embodiment, the crimping instrument 20 has a plurality of shafts 28, each of which has a distal end holding a receiving surface (not visible in this view, but discussed below) configured to receive a suture fastener. The crimping instrument also has a handle 30 that a user can grasp and a lever 32 that can be moved relative to the handle 30 for actuating a structure within the instrument 20 to crimp a suture fastener held by the device when desired. The structure that enables this will be discussed in more detail below.

[0024] Figure 2A 、2B , 2C, 2D, 2E and 2F are from Figure 1A 1 and 2. A top view, left side view, right side view, bottom view, distal view, and proximal view of one embodiment of a target mask 24 of a loading tool 22 of the target mask 24 are shown. The target mask 24 defines a plurality of snare guides 34. The target mask 24 further defines a plurality of suture openings 36, each of which is at least partially located within a corresponding one of the one or more snare guides 34. The target mask 24 further defines a suture clearance slot 38 that is coupled to (or communicates with) each of the one or more target mask suture openings 36. The target mask 24 also has a coupling latch 40.

[0025] Figure 3A 、 3B , 3C, 3D, 3E and 3F are from Figure 1A FIG. 1 shows a top view, left side view, right side view, bottom view, distal view, and proximal view of one embodiment of a target tray 26 of a loading tool 22. The target tray 26 defines a plurality of suture openings 42. The target tray 26 of this embodiment also defines a plurality of snare channels 44. The target tray 26 also has a coupling latch 46.

[0026] Figures 4A-4P is a series of exploded views showing the assembly of one embodiment of a crimping apparatus with a loading tool. Note that Figures 4I and 4O are absent to avoid possible confusion with similar looking figures.

[0027] like Figure 4A As shown, a plurality of shafts 28 are coupled to shaft spacers 48 at the proximal ends 28P of the shafts 28. Receiving surfaces 50 are disposed in the distal ends 28D of the shafts 28. A hammer 52 and anvil 54 are coupled to each receiving surface 50.

[0028] like Figure 4B As shown, a plurality of pushers 56 are coupled at proximal ends 56P to a drive link 58. The distal end 56D of each pusher 56 has a wedge-shaped tip 60 that will ultimately rest on the corresponding hammer 52 when the device is assembled and in use. In this embodiment, a cutting blade 62 is also coupled to the distal end 56D of each pusher 56.

[0029] like Figure 4C As shown, Figure 4B The pusher assembly 56A is inserted into Figure 4A In the proximal end 28P of the shaft assembly 28A.

[0030] like Figure 4DAs shown, a different shaft spacer 64 is placed on the distal end 28D of the shaft 28. The drive link 58, which is coupled to the pusher 56, is also coupled to a receiver 66 in the lever 32, and the lever shaft 68 is placed in the boss 70 of the first housing half 72. The first housing half 72 is also engaged with the shaft spacer 48.

[0031] like Figure 4E As shown, a biasing element 74 (a spring in this example) is connected between a post 76 and the lever 32 to bias the lever 32 toward a stop 78 on the housing 72. A second housing half 80 is coupled to the first housing half 72 and has a similar boss (not visible in this view) to engage another shaft 82 on the lever 32.

[0032] like Figure 4F As shown, in this embodiment, a shaft stabilizer comprising an upper stabilizer component 84A and a lower stabilizer component 84B is coupled around a portion of the exposed shaft 28 .

[0033] like Figure 4G As shown, the slidable handle 86 is slid along with another shaft spacer 88 over the distal end 28D of the shaft 28 .

[0034] Figure 4H Target mask 24 is shown in FIG. It is noteworthy that in this embodiment, there are three pairs of target mask suture openings 36A, 36B and 36C. Each pair of target mask suture openings 36A, 36B, 36C has a proximal suture opening 90 and a distal suture opening 92. Figures 2A-2F Each suture opening has a corresponding snare guide, so the proximal suture opening 90 has a plurality of corresponding proximal snare guides 94 ( Figure 4H Likewise, the distal suture opening 92 has a corresponding distal snare guide 96. Figure 4H As shown, the snare wire 98 is wrapped around the distal snare guide 96 of the first pair of snare guides to form a snare loop 98L. Figure 4J As shown, the ends 98E of the snare wire 98 are twisted together to complete the snare loop 98L. This process of forming a snare loop around each of the snare guides 96, 94 is repeated, resulting in (in this embodiment) six snare loops and six twisted snare wire ends 98E, as shown. Figure 4KEach twisted wire end 98E is threaded through a gauze 100. A first twisted end 102 is coupled to the distal snare loop of the first pair of snare loops. A second twisted end 104 is coupled to the proximal snare loop of the first pair of snare loops. A third twisted end 106 is coupled to the distal snare loop of the second pair of snare loops. A fourth twisted end 108 is coupled to the proximal snare loop of the second pair of snare loops. A fifth twisted end 110 is coupled to the distal snare loop of the third pair of snare loops. A sixth twisted end 112 is coupled to the proximal snare loop of the third pair of snare loops.

[0035] like Figure 4L As shown, the first twisted end portion 102 and the second twisted end portion 104 are further twisted together on the proximal side of the gauze 100 to form a first pair of snare threads 114. Figure 4M As shown, the third twisted end portion 106 and the fourth twisted end portion 108 are further twisted together on the proximal side of the gauze 100 to form a second pair of snare threads 116. Similarly, the fifth twisted end portion 110 and the sixth twisted end portion 112 are further twisted together on the proximal side of the gauze 100 to form a third pair of snare threads 118.

[0036] like Figure 4N As shown, the twisted snare wires 114, 116, 118 are then threaded through corresponding crimpable fasteners 120. The crimpable fasteners 120 are positioned in corresponding receiving surfaces 50 while the twisted snare wires 114, 116, and 118 are also threaded through corresponding slots 122 and into channels 124 of the sliding handle 86. In this embodiment, the twisted snare wires 114, 116, 118 are then coupled to the sliding handle 86 using fasteners 126. In this manner, the handle 86 is coupled to the plurality of snare loops such that movement of the handle (in this example, in a proximal direction) pulls the snare loops through the suture fasteners 120. The coupling latch 40 of the target mask 24 is also coupled around the shaft 28 to hold the target mask 24 in place.

[0037] like Figure 4P As shown, the target tray 26 is aligned below the target cover 24 to help prevent the snare loop from falling out of the snare loop guide prematurely. The coupling latch 46 of the target tray 26 is coupled about the shaft 28 to hold the target tray in place.

[0038] Figures 5A-5H An embodiment of an example of use of an embodiment of a loading tool 22 for loading sutures into a crimping instrument is shown. Figures 5A-5C As shown, the first suture end 128, the second suture end 130, the third suture end 132, the fourth suture end 134, the fifth suture end 136, and the sixth suture end 138 are placed through corresponding suture openings 140, 142, 144, 146, 148, and 150. The target mask 24 is then removed, as shown. Figure 5D 15. This is possible because the suture clearance slot 38 (in Figure 5C (as seen in FIG) may pass over sutures 128, 130, 132, 134, 136, and 138. Figure 5E As shown, the handle 86 is moved in a proximal direction 156, thereby pulling the proximal snare loop 152 and the distal snare loop 154 ​​toward the suture fastener (not visible in this view) held in the distal end of the device. As the snare loops 152, 154 are pulled through the fastener by movement of the handle 86, the snare sutures 128, 130, 132, 134, 136, and 138 are also pulled through the fastener. Embodiments like this in which the proximal and distal snare loops are staggered allow different sutures to be pulled through the suture fastener at different times, thereby allowing the size of the crimpable fastener to be smaller.

[0039] Figure 5F The handle 86 is shown having been moved more proximally, whereby the proximal snare loop has been pulled through the suture fastener, and the distal snare loop 154 ​​is being passed through the suture fastener.

[0040] exist Figure 5G In FIG, sutures 128, 130, 132, 134, 136, 138 are completely entrapped not only through gauze 100 but also through three suture fasteners. Although the suture fasteners are not visible in this view, there is one suture fastener in the distal end 28D of each shaft 28. Sutures 128 and 130 are threaded through the first suture fastener. Sutures 132 and 134 are threaded through the second suture fastener, and sutures 136 and 138 are threaded through the third suture fastener. Figure 5H In the embodiment shown in FIG2 , the device has been flipped over to see the suture pairs 128, 130 and 132, 134 and 136, 138 exiting the slot 122 on the underside of the shaft 28. At this point, the sutures can be tightened as desired, and the device lever can be squeezed to move the pusher distally, causing the wedge-shaped tip to press the hammer toward the anvil, crimping the suture fastener therebetween so that the suture is secured within the suture fastener. The cutting blade attached to the pusher can also cut the suture ends exiting the slot 122.

[0041] Figures 6A-6C is a partially exploded view showing another embodiment of a loading tool 158 for a surgical crimping instrument. This embodiment is similar to the previous embodiment except for the handles. In this embodiment, there are three separate handles 160 coupled to the respective twisted snare wires 114, 116, and 118. For situations where the instrument needs to be reloaded or user loaded, these separate handles 160 are easier to load by the end user, one for each receiving surface 50. Figure 6B As shown, after the handle has been loaded into the instrument, a target mask 24 may be snapped onto the instrument, and a target tray 26 may be snapped onto the instrument to cover the target mask 24 . Figure 6C The final result is shown.

[0042] Figure 7 Yet another embodiment of a loading tool 162 for a surgical crimping instrument is shown. The previous embodiment had three pairs of snare rings. This embodiment has one pair of snare rings. Other embodiments may have only one snare ring or an odd number of snare rings. Still other embodiments may have multiple snare rings, each of which is substantially equidistant from the suture fastener, such that there is no discernible difference between the proximal and distal snare rings.

[0043] Various advantages of crimping apparatus and loading tools for crimping apparatus have been discussed above. The embodiments discussed herein have been described by way of example in this specification. It will be apparent to those skilled in the art that the foregoing detailed disclosure is intended to be presented by way of example only and not by way of limitation. Although not expressly stated herein, various substitutions, improvements, and modifications may occur and are contemplated by those skilled in the art. Such substitutions, improvements, and modifications are intended to be set forth herein and are within the spirit and scope of the claimed invention. In addition, the order of the listed processing elements or sequences or the use of numbers, letters, or other designations therefor is not intended to limit the claims to any order unless otherwise specified in the claims. Therefore, the present invention is limited only by the following claims and their equivalents.

Claims

1. An apparatus for crimping each of two or more suture fasteners, the apparatus comprising: case; at least two shafts coupled to the housing, each of the at least two shafts extending along a longitudinal axis from a proximal end to a distal end, and each of the at least two shafts defining an interior portion; two or more receiving surfaces, each of the two or more receiving surfaces being received in the inner portion, the inner portion being disposed at a distal end of a corresponding one of the at least two shafts, each of the two or more receiving surfaces being coupled to a hammer and anvil, and each of the two or more receiving surfaces being configured to receive a corresponding one of the two or more suture fasteners between the hammer and the anvil; two or more pushers, each of the two or more pushers extending from a proximal end to a distal end along a longitudinal axis, and each of the two or more pushers being at least partially disposed within an interior portion of a corresponding one of the at least two shafts, each of the two or more pushers being movable in a direction parallel to the longitudinal axis of the corresponding one of the at least two shafts from a disengaged position to an engaged position in which the distal end is configured to engage at least one of the hammer and the anvil of the corresponding one of the two or more receiving surfaces to advance the hammer and the anvil together to crimp the corresponding one of the two or more suture fasteners; a drive link, wherein a proximal end of each of the two or more pushers is coupled to the drive link; and a lever movably coupled to the housing such that the lever is transferable between a first position and a second position, wherein a portion of the lever is coupled to a portion of the drive link such that when the lever is transferred from the first position to the second position, each of the two or more pushers is transferred from the disengaged position to the engaged position, wherein a portion of the suture is configured to be inserted through the hole of a corresponding one of the two or more suture fasteners, such that when the lever is shifted from the first position to the second position, the corresponding one of the two or more suture fasteners is crimped to secure the portion of the suture in the hole of the corresponding one of the two or more suture fasteners, Wherein, a loading tool is provided at or near the distal end of each of the at least two shafts, the loading tool comprising a target mask, the target mask comprising: two or more suture openings extending from a top surface to a bottom surface of the target mask, each of the two or more suture openings being defined by a peripheral edge portion; and two or more snare guides extending from a bottom surface of the target mask, each of the two or more snare guides including a protrusion extending along a corresponding one of the peripheral edge portions, wherein each of the two or more snare guides is configured to support a first portion of a snare wire around each of the two or more snare guides, wherein a second portion of the snare wire is configured to extend through a corresponding one of the two or more suture fasteners, and wherein a portion of the suture is configured to be inserted into a corresponding one of the two or more suture openings of the target mask, and a corresponding snare wire is configured to pull the portion of the suture through a hole of a corresponding one of the two or more suture fasteners.

2. The apparatus of claim 1 , further comprising a handle capable of sliding on the shaft, the handle being configured to be fixedly coupled to a third portion of the snare wire such that movement of the handle pulls a portion of the suture through a corresponding one of the two or more suture fasteners.

3. The apparatus according to claim 2, wherein: When the snare wire is connected to the handle, the fourth portion of the snare wire extends through the gauze.

4. The apparatus according to claim 1, wherein The longitudinal axes of each of the at least two shafts are parallel.

5. The apparatus of claim 1 , the loading tool further comprising a target tray movably coupled to the target mask, the target tray comprising two or more suture openings extending from a top surface to a bottom surface of the target tray, the two or more suture openings being defined by peripheral edge portions, each of the peripheral edge portions of the target tray being aligned with a corresponding one of the peripheral edge portions of the target mask such that each of the two or more suture openings of the target mask is aligned with a corresponding one of the two or more suture openings of the target tray.

6. The apparatus according to claim 5, wherein A bottom portion of each of the two or more snare guides is adjacent to a top surface of the target tray to maintain the first portion of the snare wire around a corresponding one of the two or more snare guides.

7. The apparatus according to claim 1, wherein: Each of the peripheral edge portions has an oval shape.

8. The apparatus according to claim 1, wherein Each of the peripheral edge portions extends from a proximal end to a distal end, and wherein the distal end of the peripheral edge portion of a first one of the two or more suture openings is proximal to the distal end of the peripheral edge portion of a second one of the two or more suture openings.

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