Medical device including a hemostatic clip

Abstract

An exemplary medical device is disclosed. The exemplary medical device includes a shaft having a proximal end region, a distal end region, and an outer surface. The medical device also includes a hemostatic clip coupled to the outer surface of the distal end region of the shaft, the hemostatic clip configured to shift between an open position and a closed position. Additionally, the medical device includes a tensioning member coupled to the hemostatic clip, where actuation of the tensioning member shifts the hemostatic clip between the open position and the closed position.

Description

Technical Field

[0001] The present disclosure relates to medical devices and methods for manufacturing medical devices. More specifically, the present disclosure relates to hemostatic clips connected to other structures and methods for manufacturing and using such devices.

Background Art

[0002] A variety of in vivo medical devices have been developed for medical applications, for example, for intravascular applications. Some of these devices include catheters, endoscopes, and hemostatic clips (e.g., tissue closure devices), among others. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is always a need to provide alternative medical devices and alternative methods for manufacturing and using medical devices.

Summary of the Invention

[0003] The present disclosure provides alternatives for the design, materials, manufacturing methods, and use of medical devices. An exemplary medical device includes a shaft having a proximal end region, a distal end region, and an outer surface. The medical device also includes a hemostatic clip coupled to the outer surface of the distal end region of the shaft, the hemostatic clip being configured to shift between an open position and a closed position. Further, the medical device includes a tension member coupled to the hemostatic clip, and actuation of the tension member shifts the hemostatic clip between the open position and the closed position.

[0004] Instead of or in addition to any of the above embodiments, the hemostatic clip includes an upper jaw pivotable relative to a lower jaw, and the tension member is coupled to a portion of the upper jaw. Instead of or in addition to any of the above embodiments, the upper jaw includes an opening, and the tension member extends through the opening.

[0005] Instead of or in addition to any of the above embodiments, a shearing member is further provided, and the shearing member is connected to the upper jaw, the tension member, or both the upper jaw and the tension member. Instead of or in addition to any of the above embodiments, the shearing member is connected to the tension member at the welding connection portion, and by moving the shearing member relative to the tension member, the welding connection portion is cut and the tension member is separated from the shearing member.

[0006] Instead of or in addition to any of the above embodiments, a rivet connects the shearing member to the tension member, and by moving the shearing member relative to the tension member, the rivet is cut and the tension member is separated from the shearing member.

[0007] Instead of or in addition to any of the above embodiments, when the upper jaw is pivoted relative to the lower jaw, the lower jaw is held in a fixed position relative to the upper jaw. Instead of or in addition to any of the above embodiments, a cap arranged along the distal end region of the shaft is further provided, and the hemostatic clip is removably attached to the outer surface of the cap.

[0008] Instead of or in addition to any of the above embodiments, the cap includes a first protrusion, and the hemostatic clip includes a curved portion configured to engage with the first protrusion. Instead of or in addition to any of the above embodiments, a portion of the shearing member engages with a portion of the first protrusion.

[0009] Instead of or in addition to any of the above embodiments, the cap includes a connecting member configured to translate from a first position to a second position, and by shifting the connecting member from the first position to the second position, the hemostatic clip is released from the cap.

[0010] Instead of or in addition to any of the above embodiments, a release member connected to the connecting member is further provided, and by retracting the release member, the connecting member is translated from the first position to the second position.

[0011] An exemplary endoscope includes a handle and a shaft coupled to the handle. The shaft has a proximal end region, a distal end region, and an outer surface. The endoscope also includes a cap disposed along the distal end region of the shaft and a hemostatic clip removably attached to the outer surface of the cap. The hemostatic clip is configured to shift between an open position and a closed position. Further, the endoscope also includes a tension member coupled to the hemostatic clip, and actuation of the tension member shifts the hemostatic clip between the open position and the closed position.

[0012] Instead of or in addition to any of the above embodiments, the hemostatic clip includes an upper jaw pivotable relative to a lower jaw, and the tension member is coupled to a portion of the upper jaw. Instead of or in addition to any of the above embodiments, the upper jaw includes an opening, and the tension member extends through the opening.

[0013] Instead of or in addition to any of the above embodiments, the endoscope further includes a shearing member coupled to the upper jaw, the tension member, or both the upper jaw and the tension member. Instead of or in addition to any of the above embodiments, when the upper jaw is rotated relative to the lower jaw, the lower jaw is held in a fixed position relative to the upper jaw.

[0014] Instead of or in addition to any of the above embodiments, the cap includes a first protrusion, and the hemostatic clip includes a curved portion configured to engage the first protrusion. Instead of or in addition to any of the above embodiments, the upper jaw pivots relative to the lower jaw about the first protrusion.

[0015] An exemplary method of attaching a hemostatic clip to a target tissue includes advancing an endoscope to the target tissue, the endoscope including a shaft having a proximal end region, a distal end region, and an outer surface. The endoscope also includes a hemostatic clip coupled to the outer surface of the distal end region of the shaft, the hemostatic clip being configured to shift between an open position and a closed position. Further, the endoscope also includes a tension member coupled to the hemostatic clip. The method further includes retracting the tension member to shift the hemostatic clip to the open position, engaging the hemostatic clip with the target tissue, and releasing the tension member to shift the hemostatic clip to the closed position.

[0016] The above summary of some embodiments is not intended to describe every disclosed embodiment or all of the implementations of the present disclosure. The following drawings and detailed description illustrate these embodiments more specifically.

Brief Description of the Drawings

[0017] The present disclosure may be more fully understood by considering the following detailed description in connection with the accompanying drawings.

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[0018] Although the present disclosure is amenable to various modifications and alternative forms, specific details thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the present disclosure to the particular forms disclosed. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

[0019] Unless different definitions are provided in the claims or other parts of this specification, the terms defined below shall apply. Whether or not explicitly indicated, all numerical values are assumed to be modified in this specification by the term "about". The term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant digit.

[0020] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in the sense of "and / or" unless the context clearly dictates otherwise.

[0021] Note that references in this specification to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such descriptions do not necessarily mean that all embodiments include the specific features, structures, and / or characteristics. Additionally, when a specific feature, structure, and / or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless expressly stated to the contrary.

[0022] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings are not necessarily to scale and illustrate exemplary embodiments and are not intended to limit the scope of the present disclosure.

[0023] Pathologies of body lumens and hollow organs are often treated via endoscopic procedures, many of which may require a mechanism for controlling bleeding. Instruments for deploying hemostatic clips via an endoscope are often used to stop internal bleeding by clamping together the edges of a wound or incision. Multiple hemostatic clips (e.g., wound closure devices) can grip the tissue surrounding a wound and hold the edges of the wound together by applying pressure to the target tissue site so that the natural healing process can close the wound. Multiple special endoscopic clipping devices are used to deliver multiple clips to a desired location within the body and to position and deploy the multiple clips at the desired location, after which the clip delivery device is withdrawn, leaving the clips within the body. These clips may remain in place until they are removed via a natural process or until they are removed via a separate procedure after the bleeding site has healed later.

[0024] FIG. 1 shows an exemplary medical device 10 including a distal end and a proximal end. The medical device 10 may include a shaft 14 having a proximal end region and a distal end region. In some examples, the shaft 14 can include an endoscope, a laparoscope, a catheter, a guide tube, and the like. As will be described in more detail below, the distal end of the medical device 10 can be advanced within a portion of a body cavity to a position adjacent to a target tissue such as a lesion, while the proximal end of the medical device system 10 can extend out of the body cavity to a position outside the body.

[0025] FIG. 1 further shows that the proximal end region of the shaft 14 can be connected to a control member 12 (e.g., a handle, an actuator, etc.). The control member 12 may be utilized as a grip for controlling the translation of the shaft 14. Further, the control member 12 may also allow a user to rotate the shaft 14. As described in more detail below, the control member 12 may be utilized by a clinician to advance the distal end region of the shaft 14 to a position adjacent to the target tissue to perform a medical procedure. In addition, the control member 12 may include one or more actuators, gears, levers, etc. that allow a clinician to operate the shaft 14 in addition to other characteristic components of the medical device 10 (e.g., a wound closure device).

[0026] In some examples, the medical device 10 may include additional features. For example, the medical device 10 shown in FIG. 1 may include a hemostatic clip 18 (e.g., a defect closure device) disposed on the distal end region of the shaft 14 (e.g., an endoscope). In some examples, such as the example shown in FIG. 1, the hemostatic clip 18 may be disposed along the outer surface of the shaft 14. This type of hemostatic clip may be referred to as an "over-the-scope" clip (e.g., OTSC) since the clip 18 is disposed on the outer surface of the shaft 14 (e.g., an endoscope) or other similar medical device.

[0027] As described in more detail below, the hemostatic clip 18 can be utilized to close or occlude a bleeding target tissue site during or after a surgical procedure. For example, if the target tissue is cut during surgery, the hemostatic clip can be utilized to grasp the cut tissue and immediately stop the bleeding. Thus, the hemostatic clip needs to be actuated to grasp the tissue and then remain attached to the target tissue site until the bleeding stops after being removed from the medical device 10. As described in more detail below, FIG. 1 shows an actuation sheath 16 attached to the shaft 14. The actuation sheath 16 may include a lumen through which one or more actuation members (shown in FIG. 2) extend and can be connected to the hemostatic clip 18.

[0028] Figure 2 shows the distal end of the medical device 10. As shown in Figure 2, one or more lumens 36 can extend through the shaft 14 from its proximal end region to its distal end region. In some examples, one or more lumens 36 can be referred to as the "working channels" of the medical device 10. The working channels may be designed to allow various medical devices to pass therethrough. For example, a clinician may pass or exchange various medical devices through the working channel 36 over the course of a given medical procedure. The plurality of medical devices that have passed through the working channel 36 may be utilized to treat the tissue target site. While reference numeral 36 can indicate the working channel, it can be further understood that other reference numerals can indicate additional working channels of the shaft 14 or other features of the shaft 14 (e.g., an endoscope), such as an LED light, a water jet, a camera, etc.

[0029] Furthermore, Figure 2 shows a hemostatic clip 18 disposed on the distal end region of the shaft 14. However, Figure 2 further shows that the shaft 14 can include a cap 20 disposed on its distal end. The cap 20 can be disposed on the outer surface of the shaft 14 and can extend around the outer surface of the shaft 14. In some examples, it can be understood that the cap 20 can include an outer diameter that is larger than the outer diameter of the shaft 14. Furthermore, Figure 2 shows the distal end of the cap that can be longitudinally aligned with the end of the shaft 14 (e.g., aligned with the end of the endoscope 14).

[0030] FIG. 2 further shows that the cap 20 can include one or more protrusions 26 that extend radially outward from the outer surface of the cap 20. FIG. 2 shows a first protrusion 26 that extends radially outward from the outer surface of the cap 20, but in some examples, a second protrusion 27 may be disposed 180 degrees away from the first protrusion 26 (e.g., on the other side of the cap 20), such that the central regions of the first protrusion 26 and the second protrusion 27 may be aligned along a common axis. For example, FIG. 9 shows an alternative embodiment of the medical device 10 having a first protrusion 126 aligned with a second protrusion 127. The same configuration may be utilized for the medical device 10 shown in FIG. 2.

[0031] It can be understood from FIG. 2 that in some examples, the hemostatic clip 18 can be disposed along a portion of the cap 20. For example, FIG. 2 shows that the hemostatic clip 18 can be disposed on the outer surface of the cap 20. FIG. 2 further shows that the hemostatic clip 18 can include an upper jaw 24 and a lower jaw 22 that are connected to each other via one or more curved (e.g., bent) portions 40. For example, FIG. 4 shows that the hemostatic clip 18 can include a first curved portion 40 and a second curved portion 42 (shown in FIG. 4) that connect the upper jaw 24 to the lower jaw 22. As described in more detail below with respect to FIG. 4, the upper jaw 24 of the hemostatic clip 18 may include one or more upper teeth 30, and the lower jaw 22 of the hemostatic clip 18 may include one or more lower teeth 28.

[0032] In some examples, the first curved portion 40 may be configured to engage the protrusion 26, and the second curved portion 42 (shown in FIG. 4) may be configured to engage the second protrusion 27 of the cap 20. For example, each of the first curved portion 40 and the second curved portion 42 may be shaped to respectively conform to the first protrusion 26 and the second protrusion 27 of the cap 20. Further, in some examples, it can be understood that the first curved portion 40 and the second curved portion 42 can each be designed to form a press fit with the first protrusion 26 and the second protrusion 27 respectively. In other words, in some examples, the first curved portion 40 and the second curved portion 42 of the hemostatic clip 18 can be designed to "snap" onto the first protrusion 26 and the second protrusion 27 of the cap 20 respectively. The engagement between the first curved portion 40 and the second curved portion 42 of the hemostatic clip 18 may form a removably fixed connection of the hemostatic clip 18 to the cap 20.

[0033] FIG. 2 shows that the medical device 10 can also include a tension wire 32 and a shear wire 34, each of which can be connected to the hemostatic clip 18. It can be understood that each of the tension wire 32 and the shear wire 34 extends from the hemostatic clip 18 through the actuation sheath 16 and can be connected to the control member 12 (shown in FIG. 1).

[0034] As described above, the hemostatic clip 18 may be utilized to grasp and occlude tissue as a target tissue site. Thus, it can be understood that the hemostatic clip 18 can be actuated between a first position (e.g., a closed position as shown in FIG. 2) and a second position (e.g., an open position as shown in FIG. 3). It can be further understood that the upper jaw 24 can be rotated relative to the lower jaw 22 to actuate the hemostatic clip 18 between the first position and the second position. Thus, in some examples, the lower jaw 22 may be held in a fixed position relative to the cap 20, whereby the upper jaw 24 may be rotated relative to the lower jaw 22 (which is held in a fixed position relative to the cap 20).

[0035] It can further be appreciated that in order to actuate the upper jaw 24 relative to the lower jaw 22, it may be necessary to apply a force to the upper jaw 24 to rotate it away from the lower jaw 22. Thus, in some examples, a tension member 32 (e.g., a tension wire) may be utilized to provide the upper jaw with a force to rotate the upper jaw relative to the lower jaw 22.

[0036] For example, FIG. 3 shows that the tension member 32 can be translated in a distal-to-proximal direction through the lumen 38 of the actuation sheath 16. As described above (and as further described with respect to FIGS. 5-6 below), the tension member 32 may be coupled to the upper jaw 24 of the hemostatic clip 18. Thus, by translating the tension member 32 in a distal-to-proximal direction, the upper jaw 24 can be effectively rotated and separated from the lower jaw 22 (which may remain fixed to the cap 20). FIG. 3 further shows that the first curved portion 40 and the second curved portion 42 may remain engaged with the first protrusion 26 and the second protrusion 27 when the upper jaw 24 rotates relative to the lower jaw 22. In other words, the first protrusion 26 and the second protrusion 27 can function as pivot points for the first curved portion 40 and the second curved portion 42 when the upper jaw 24 rotates relative to the lower jaw 22.

[0037] It should be understood that translation of the tension member 32 through the actuation sheath 16 may be effected by one or more actuating components of the control member 12. For example, a clinician may manipulate one or more actuating components of the control member 12 to shift the hemostatic clip 18 between a first position (e.g., an open position) and a second position (e.g., a closed position). In some examples, a clinician may manipulate a control knob 13 (shown in FIG. 1 ) to shift the hemostatic clip 18 between a first position (e.g., an open position) and a second position (e.g., a closed position). The knob 13 may be rotated in a clockwise or counterclockwise direction to translate the tension member 32 in either a proximal or distal direction. However, this is not intended to be limiting. Rather, the handle 12 may include a lever, slider, or any other actuating component that actuates the tension member to shift the hemostatic clip 18 between a first position (e.g., an open position) and a second position (e.g., a closed position).

[0038] Additionally, it may be appreciated that in some instances, the upper jaw 24 may be biased to a second configuration (e.g., a closed configuration). For example, while stationary, the upper jaw 24 may be biased to close relative to the lower jaw 22. This feature may be accomplished by the first curved portion 40 and the second curved portion 42, which may act as spring elements to bias the upper jaw 24 to the closed configuration. Thus, after the upper jaw 24 is rotated to an open position via the tensioning member 32 (as described above), the upper jaw 24 may be closed relative to the lower jaw 22 by releasing the tensioning member 32.

[0039] Figure 3 further shows that the cutting member 34 can be advanced distally from the proximal end of the lumen 38 of the delivery sheath 16 while the tension member 32 is being translated proximally from the distal end to rotate the upper jaw 24 relative to the lower jaw 22. As described above (and further described with respect to FIGS. 5-6 below), the cutting member 32 may be coupled to the upper jaw 24 of the hemostatic clip 18 (as described below, the cutting member 32 may be coupled to both the tension member 32 and the upper jaw 24). Thus, when the tension member 32 is being translated proximally from the distal end to rotate the upper jaw 24 relative to the lower jaw 22, the cutting member 34 can be “pulled out” (e.g., withdrawn) from the lumen 38 as the tension member 32 is translated into the lumen 38. Similar to what was described above with respect to the tension member 32, a clinician can operate one or more actuating components of the control member 12 to enable the cutting member 34 to be withdrawn from the lumen 38 of the actuating sheath 16 as the tension member 32 is pulled into the lumen 38 of the actuating sheath 16. In some embodiments, it can be appreciated that a single actuating component on the control member 12 can enable the cutting member 34 to be withdrawn from the lumen 38 of the actuating sheath 16 at the same time the tension member 32 is being drawn into the lumen 38 of the actuating sheath 16.

[0040] Figure 4 shows an exemplary hemostatic clip 18 removed from the medical device 10. As described above, the hemostatic clip 18 can include an upper jaw 24 and a lower jaw 22. The upper jaw 24 can be connected to the lower jaw 22 via a first curved portion 40 and a second curved portion 42. Further, FIG. 4 shows that the first curved portion 40 and the second curved portion 42 can be shaped to receive the first protrusion 26 and the second protrusion 27 of the cap 20 as described above.

[0041] FIG. 4 further shows that the first curved portion 40 and the second curved portion 42 can be spaced apart from each other to enable the hemostatic clip 18 to be inserted onto the cap 20. For example, before tracking the shaft 14 to the target tissue site, the distal end region of the shaft 14 may be inserted between the first curved portion 40 and the second covering portion 42, whereby the hemostatic clip 18 can then be advanced along the outer surface of the cap 20 until the first protrusion 26 and the second protrusion 27 engage the first curved portion 40 and the second curved portion 42 of the hemostatic clip 18. It can be appreciated that in this configuration, the hemostatic clip 18 can be removably attached to the cap 20.

[0042] As described above, FIG. 4 shows that the upper jaw 24 can include a plurality of teeth 30 and the lower jaw can include a plurality of teeth 28. The plurality of teeth 30 may resemble a row of teeth 30, whereby it can be further appreciated that the individual teeth 30 can be aligned with each other along the curve of the upper jaw 24. Similarly, the plurality of teeth 28 may resemble a row of teeth 28, whereby it can be appreciated that the individual teeth 28 can be aligned with each other along the curve of the lower jaw 22.

[0043] FIG. 4 further shows that one or more teeth 30 of the upper jaw 24 and one or more teeth 28 of the lower jaw 22 can be curved inwardly from the front face of the hemostatic clip 18 towards the proximal end region of the hemostatic clip 18. For example, one or more teeth 30 of the upper jaw 24 may be curved inwardly from the distal opposing face of the upper jaw 24 towards the proximal portion of the upper jaw 24, while one or more teeth 28 of the lower jaw 22 may be curved inwardly from the distal opposing face of the lower jaw 22 towards the proximal portion of the lower jaw 22. When utilized to grasp tissue at the target tissue site, the inward curvature of one or more teeth 30 of the upper jaw 24 and the inward curvature of one or more teeth 28 of the lower jaw 22 can be appreciated to enable the teeth 30 to grasp and pull the tissue together between the upper jaw 24 and the lower jaw 22 of the hemostatic clip 18.

[0044] As described above, after the hemostatic clip 18 is actuated to grip the tissue at the target tissue site using the tension member 32, it can be appreciated that it may be desirable to remove the tension member 32 from the upper jaw 24 of the hemostatic clip 18 so that the hemostatic clip 18 can remain clamping the target tissue until the target tissue is occluded (e.g., bleeding stops). Accordingly, FIGS. 5-6 show two exemplary configurations in which the shearing member 34 can be utilized to remove the tension member 32 from the upper jaw 24 of the hemostatic clip 18.

[0045] FIG. 5 shows an exemplary configuration in which the shearing member 34 can be utilized to remove the tension member 32 from the upper jaw 24 of the hemostatic clip 18. FIG. 5 shows that in some examples, the tension member 32 can first be wound through an opening 48 disposed in the upper jaw 24. For example, FIG. 5 shows that the tension member 32 can be wound through the opening 48 onto the top surface (e.g., upper surface) of the upper jaw 24 and extend proximally toward the proximal end region of the upper jaw 24. Additionally, referring to FIGS. 2 and 5, the shearing member 34 may extend from the lumen 38 of the actuation sheath 16 around the first protrusion 26 and behind the upper jaw 24, whereby the distal end of the shearing member 34 may be fixed between the distal end of the tension member 32 and the proximal portion of the tension member 32. From FIG. 5, it can be appreciated that the distal end of the shearing member 34, the distal end of the tension member 32, and the proximal portion of the tension member 32 can be welded together to form a welded connection 50.

[0046] After the hemostatic clip 18 is actuated to initially grasp the tissue at the target tissue site (e.g., the hemostatic clip 18 is opened via operation of the tension member 32 and closed to grasp the tissue at the target tissue site), it can be understood that the hemostatic clip 18 may be opened again (via operation of the tension member 32) to re-grasp the tissue at the tissue target site. For example, in some instances, a clinician may initially utilize the medical device 10 to attach the hemostatic clip 18 to the tissue at the target tissue site. However, in some instances, the initial grasping of the tissue may be insufficient. Thus, a clinician may desire to reposition the hemostatic clip 18 along the target tissue site. Accordingly, the clinician can operate the control member 12 to actuate the hemostatic clip 18 (via operation of the tension member 32) to re-grasp the tissue. The re-grasping of the tissue may be repeated by the clinician until an appropriate amount of tissue is positioned between the upper jaw 24 and the lower jaw 22 of the hemostatic clip 18.

[0047] After the hemostatic clip 18 is actuated to grasp the tissue at the target tissue site (e.g., the hemostatic clip 18 is opened and closed via operation of the tension member 32 to grasp the tissue at the target tissue site), it can be further understood that the shearing member 34 can be translated in a distal-to-proximal direction while tension is applied to the tension member 32, thereby shearing (e.g., splitting, breaking, cutting, etc.) the welded connection 50. In some examples, one or more actuating members of the control member 12 may be utilized to break the welded connection 50 by pulling the shearing member 34 in a distal-to-proximal direction while applying an appropriate amount of tension to the tension member 32.

[0048] By shearing the welded connection 50, it can be further understood that the distal end of the tension member 32 can be retracted through the opening 48, thereby releasing the tension member 32 and the shearing member 34 from the upper jaw 24. However, as described above, it should be noted that the welded connection 50 may be designed to have sufficient strength to allow the tension member 32 to rotate the upper jaw 24 relative to the lower jaw 22 (before breaking the welded connection 50).

[0049] FIG. 6 shows another exemplary configuration in which the shearing member 34 can be utilized to remove the tension member 32 from the upper jaw 24 of the hemostatic clip 18. FIG. 6 shows that in some examples, the tension member 32 can be disposed (e.g., wound) through the opening 48 disposed in the upper jaw 24. For example, FIG. 6 shows that the tension member 32 can be wound around the top surface (e.g., the upper surface) of the upper jaw 24 through the opening 48 and extend proximally toward the proximal end region of the upper jaw 24. Additionally, referring to FIGS. 2 and 6, the shearing member 34 may extend from the lumen 38 of the actuation sheath 16 around the first protrusion 26 and behind the upper jaw 24, whereby the distal end of the shearing member 34 may be fixed between the distal end of the tension member 32 and the proximal portion of the tension member 32. From FIG. 6, it can be understood that the distal end of the shearing member 34, the distal end of the tension member 32, and the proximal portion of the tension member 32 can be connected together via a rivet 54 to form a rivet connection 52.

[0050] After the hemostatic clip 18 is actuated to grip the tissue at the target tissue site (e.g., the hemostatic clip 18 is opened and then closed to grip the tissue at the target tissue site via operation of the tension member 32), it can be further understood that the shearing member 34 is translated in the distal-to-proximal direction while tension is applied to the tension member 32, thereby being able to shear (e.g., split, break, cut, etc.) the rivet 54 of the rivet connection portion 52. In some examples, one or more actuating members of the control member 12 may be utilized to break the rivet 54 of the rivet connection portion 52 by pulling the shearing member 34 in the distal-to-proximal direction while applying an appropriate amount of tension to the tension member 32.

[0051] It can be further understood that by breaking the rivet 54 of the rivet connection portion 52, the distal end of the tension member 32 can be retracted through the opening 48, thereby releasing the tension member 32 and the shearing member 34 from the upper jaw 24. However, as noted above, it should be noted that the rivet connection portion 52 may be designed to have sufficient strength to allow the tension member 32 to rotate the upper jaw 24 relative to the lower jaw 22 (before breaking the rivet connection portion 52).

[0052] As described above, FIGS. 7 and 8 show a medical device utilized to attach the hemostatic clip 18 to a target tissue site. The tension member 32 is used to actuate the hemostatic clip 18 from a first position (e.g., a closed position as shown in FIG. 2) to a second position (e.g., an open position as shown in FIG. 3), and after the shaft 14 of the medical device 10 is advanced toward the tissue 56, the hemostatic clip 18 is closed and then returned to the first position to capture the target tissue between the teeth 30 of the upper jaw 24 and the teeth 28 of the lower jaw 22, as can be understood from FIG. 7. As described above, the hemostatic clip 18 may be repeatedly actuated to grip and re-grip the tissue until a desired amount of tissue is captured.

[0053] FIG. 8 shows that after a desired amount of target tissue is captured between the teeth 30 of the upper jaw 24 and the teeth 28 of the lower jaw 22 of the hemostatic clip 18, the shearing member 34 can be retracted through the lumen 38 of the actuation sheath 16 while tension is maintained on the tension member 32. As described above, by retracting the shearing member 34 in a distal-to-proximal direction around the first protrusion 26, the connection between the tension member 32 and the shearing member 34 can be sheared (e.g., broken). It can be understood that the tension member 32 and the shearing member 34 may be connected to each other via the welded connection 50 or the rivet connection 52 described above. Further, it should be noted that this is not intended to be limiting. Other connection configurations between the tension member 32 and the shearing member 34 are envisioned.

[0054] FIG. 8 further shows that after the connection between the tension member 32 and the shearing member 34 is broken, the distal end 62 of the tension member 32 can pass through the opening 48, thereby releasing the tension member 32 from the hemostatic clip 18. Additionally, FIG. 8 shows the distal end 60 of the shearing member 34 without the hemostatic clip 18. Thus, it can be understood that a clinician can pull the shaft 14 (including the cap 20) out of the hemostatic clip 18, thereby releasing the hemostatic clip 18 from the cap 20. The pulling of the shaft 14 relative to the hemostatic clip 18 is indicated by arrow 58 in FIG. 8. It can be understood that the medical device 10 (including the shaft 14, the cap 20, the actuation sheath 16, the tension member 32, and the shearing member 34) can be withdrawn from the body while the hemostatic clip 18 remains attached to the target tissue site 56.

[0055] FIG. 9 shows a plan view of another exemplary medical device 100. The medical device 100 may be similar in form and function to the medical device 10 described above. For example, the medical device 100 may include a hemostatic clip 118 (similar to the hemostatic clip 18) disposed on the outer surface of the shaft 114. Further, the medical device 100 can include a cap 120 similar to the cap 20 described above with respect to the medical device 10.

[0056] FIG. 9 further shows that the medical device 100 may include a tension member 132 that extends through an actuating sheath 116 (disposed at the upper portion of the shaft 114). FIG. 9 further shows that the tension member 132 may include a first tension arm 133 connected to the upper jaw 124 at a first welded connection 144. Additionally, FIG. 9 shows that the tension member 132 may include a second tension arm 135 connected to the upper jaw 124 at a second welded connection 145.

[0057] Additionally, FIG. 9 shows that the medical device 100 may further include a first shearing member 134 and a second shearing member 136. Further, the first shearing member 134 exits the actuating sheath 116 and extends around a first protrusion 126 (extending away from the outer surface of the shaft 14) and may be connected to the upper jaw 124 and / or the first tension arm 133 at the first welded connection 144. Additionally, the second shearing member 136 exits the actuating sheath 116 and extends around a second protrusion 127 (extending away from the outer surface of the shaft 14) and may be connected to the upper jaw 124 and / or the second tension arm 135 at the second welded connection 144.

[0058] It can be understood that the medical device 100 may function in a similar manner to the medical device 10 described above. For example, the hemostatic clip 118 may be actuated between an open configuration and a closed configuration via the actuation of the tension member 132. However, it will be understood that each of the first tension arm 133 and the second tension arm 135 can apply a retraction force substantially equal to that of the upper jaw 124 when the upper jaw is actuated. Further, as described above with respect to the medical device 10, the hemostatic clip 118 may be repeatedly actuated to grip and re-grip tissue until a desired amount of tissue is captured.

[0059] In addition, after the tension member 132 is operated to open and close the hemostatic clip 118 to grip the tissue at the target tissue site, each of the first shearing member 134 and the second shearing member 136 is retracted (while tension is maintained on the tension member 132), whereby it can be further understood that the first connecting weld 144 and the second connecting weld 145 are broken. It will be understood that the first connecting weld 144 and the second connecting weld 145 may be similar in form and function to the connecting weld 50 described above.

[0060] In addition, after the first connecting weld 144 and the second connecting weld 145 are broken, it can be understood that the medical device 100 (including the shaft 114, the actuating sheath 116, the tension member 132, the first shearing member 134, and the second shearing member 136) can be retracted (and removed from the body) while the hemostatic clip 118 is attached to the tissue at the target tissue site.

[0061] FIG. 10 shows another exemplary medical device 200. The medical device 200 may be similar to other medical devices disclosed herein. For example, the medical device 200 may include a hemostatic clip 218 disposed on the outer surface of the cap 220, whereby the cap 220 is disposed on the distal end region of the shaft 214. In some examples, the shaft 214 can include an endoscope, a laparoscope, a catheter, a guide tube, and the like. As will be described in more detail below, the distal end of the medical device 200 can be advanced within a portion of the body cavity to a position adjacent to a target tissue such as a lesion, while the proximal end of the medical device system 200 can be extended out of the body cavity to a position outside the body.

[0062] As shown in FIG. 10, one or more lumens 236 may extend through the shaft 214 from its proximal end region to its distal end region. In some embodiments, the one or more lumens 236 may be referred to as the "working channels" of the medical device 200. The working channels may be designed to allow various medical devices to pass therethrough. For example, a clinician may pass or exchange various medical devices through the working channel 236 over the course of a given medical procedure. The plurality of medical devices passing through the working channel 236 may be utilized to treat the tissue target site. While reference numeral 236 may indicate the working channel, it is further understood that other reference numerals may indicate additional working channels of the shaft 214 or other features (such as LED lights, water jets, cameras, etc.) of the shaft 214 (e.g., an endoscope).

[0063] It is further understood that the proximal end region of the shaft 214 may be coupled to a control member (similar to the control member 12 described above). The control member 12 may be utilized as a grip for controlling the translation of the shaft 214. Further, the control member may also allow the user to rotate the shaft 214. The control member may be utilized by a clinician to advance the distal end region of the shaft 214 to a position adjacent to the target tissue to perform a medical procedure. In addition, as described above, the control member 12 may include one or more actuators (such as the knob 13), gears, levers, etc., that allow the clinician to manipulate the shaft 214 in addition to the other feature components of the medical device 200.

[0064] As described above, the medical device 200 shown in FIG. 10 may include a hemostatic clip 218 (e.g., a defect closure device) disposed on a cap 220 disposed on the distal end region of a shaft 214 (e.g., an endoscope). In some examples, such as the example shown in FIG. 10, the hemostatic clip 218 may be disposed along the outer surface of the cap 220. This type of hemostatic clip may be referred to as an "over-the-scope" clip since the clip 218 is disposed on the outer surface of the cap 220 (e.g., an endoscope) or other similar medical device.

[0065] In addition, FIG. 10 further shows that the hemostatic clip 218 may include a connection to the lower jaw 222 of the upper jaw 224. In addition, FIG. 10 shows that the upper jaw 224 may include one or more teeth 230 and the lower jaw may include one or more teeth 228. In some examples, the teeth 228 of the lower jaw 222 may extend into the gap between two of the teeth 230 of the upper jaw 224 (e.g., may be nested therein).

[0066] FIG. 10 further shows that the medical device 200 can include a tension member 232 connected to the upper jaw 224 of the hemostatic clip 218 at a welded connection 264. Similar to the medical device 10 described above, the tension member 232 may be utilized to actuate the hemostatic clip 218 between a first position (e.g., a closed position) and a second position (e.g., an open position). For example, by retracting the tension member 232 in a distal to proximal direction, the upper jaw 224 can be pulled, thereby rotating the upper jaw 224 relative to the lower jaw 222.

[0067] In some examples, the lower jaw 222 may be relatively fixed with respect to the upper jaw 224. For example, FIG. 11 shows that when the tension member 232 is retracted in a distal to proximal direction, the upper jaw 224 can pivot with respect to a first protrusion 226 and a second protrusion 227 that extend away from the outer surface of the cap 220, while the lower jaw 222 remains in a fixed position with respect to the upper jaw 224.

[0068] As shown in FIG. 11, when the tension member 232 is retracted in the distal-to-proximal direction (e.g., via operation of the control member 12), the upper jaw 224 may rotate away from the lower jaw 222, thereby separating the teeth 230 of the upper jaw 224 from the teeth 228 of the lower jaw 222. In this configuration, the medical device 200 may be advanced toward the tissue target site, whereby the target tissue is disposed between the teeth 230 of the upper jaw 224 and the teeth 228 of the lower jaw 222. When the target tissue is disposed between the upper jaw 224 and the lower jaw 222, the tension member 232 may be released (thereby releasing the contraction force applied to the upper jaw 224), which allows the upper jaw 224 to approach the lower jaw 222, thereby capturing the target tissue between the teeth 230 and the teeth 228. As described above, the hemostatic clip 218 may be repeatedly actuated to grip and re-grip the tissue until a desired amount of tissue is captured.

[0069] In some examples (such as the exemplary medical device shown in FIGS. 10-11), the hemostatic clip 218 may be coupled to the cap 220 (and thus the shaft 214) via a coupling member 266 and a release member 268. Further, similar to the medical device 10 described above, after the target tissue has been captured by the hemostatic clip 218 (as described above), the shaft 214, the cap 220 (including the coupling member 266 and the release member 268), and the tension member 232 may be separated from the hemostatic clip 218 (e.g., retracted, released, etc.) and removed from the body. The hemostatic clip 218 may remain in the body and be attached to the target tissue site.

[0070] FIGS. 12-15 illustrate the attachment and operation of the coupling member 266 and the release member 268 to the hemostatic clip 218. FIG. 12 shows the hemostatic clip 218 released from the cap 220 as described above. FIG. 12 further shows that the hemostatic clip 218 may include a slot 272 disposed along the bottom surface of the hemostatic clip 218. For example, FIG. 12 shows that the slot 272 may be formed within a portion of the lower jaw 222 of the hemostatic clip 218.

[0071] Furthermore, FIG. 12 shows that the cap 220 may include a connecting member 266 spaced apart from a protrusion 270 (such as a rail, stabilizer, shelf, ledge, etc.) to define an opening 274. In some examples, the protrusion 270 may be vertically aligned with the connecting member 266 (e.g., the protrusion 270 is vertically disposed on the connecting member 266), whereby it can be understood that the shape of the protrusion 270 substantially reflects the shape of the connecting member 266. However, this is not intended to be limiting. Rather, it is envisioned that the protrusion 270 and the connecting member 266 may have different shapes from each other.

[0072] It can be further understood that the shapes of the protrusion 270 and the connecting member 266 may be configured to fit the shape of the slot 272 of the hemostatic clip 218. In other words, the shapes of the protrusion 270 and the connecting member 266 may be designed such that the protrusion 270 and the connecting member 266 can be slid on the hemostatic clip 218, whereby the wall of the hemostatic clip 218 defining the slot 272 can be inserted into the opening 274 defined between the protrusion 270 and the connecting member 266. In other words, a portion of the hemostatic clip 218 defining the slot 272 is sandwiched between the protrusion 270 and the connecting member 266, whereby the hemostatic clip 218 can be removably attached to the cap 220.

[0073] In some examples, it can be understood that both the protrusion 270 and the connecting member 266 can be fixedly attached to the cap 220. In other words, in some examples, both the protrusion 270 and the connecting member 266 may be fixed to the cap 220 so as not to move (e.g., shift, translate, etc.) relative to the cap 220. In this configuration, the combination of the protrusion 270 and the connecting member 266 is inserted into the slot 272 (shown by reference numeral 276 in FIG. 12), defining a fixed opening 274 from which it can be retracted, thereby removably attaching the cap 220 to the hemostatic clip 218.

[0074] However, in other examples, the connecting member 266 may be designed to translate (e.g., slide, shift, move, etc.) relative to the fixed protrusion 270 and the cap 220. In this configuration, the translation of the connecting member 266 "releases" the cap 220 from a first "locked" configuration (thereby preventing the cap 220 from being removed from the hemostatic clip 218 until the connecting member 266 translates relative to the protrusion 270) to a second "unlocked" (e.g., released) configuration (thereby allowing the cap 220 to be removed from the hemostatic clip 218 after the connecting member 266 translates relative to the protrusion 270).

[0075] It can be understood that the translation of the connecting member 266 can be achieved by the proximal-to-distal retraction of the release member 268. For example, FIG. 13 shows the proximal-to-distal retraction of the release member 268 to translate the connecting member 266 in the proximal-to-distal direction relative to the protrusion 270. As described above, the proximal-to-distal retraction of the connecting member 266 releases the connecting member 266 from the hemostatic clip 218 (e.g., shifts the connecting member 266 from the locked configuration to the unlocked configuration), thereby allowing the cap 220 to be retracted proximally and removed from the hemostatic clip 218.

[0076] Figures 14 and 15 show the distal-to-proximal translation of the above-described connecting member 266. For example, the figure shows the bottom side of the cap 220, whereby the connecting member 266 is fully translated distally with respect to the protrusion 270 (note that the protrusion 270 is hidden by the connecting member 266 in FIG. 14). In this configuration, the connecting member 266 may be locked to the hemostatic clip 218 (for clarity, the hemostatic clip is not shown in FIGS. 14 and 15). FIG. 14 further shows that the connecting member 266 can translate within a first longitudinal rail 280 and a second longitudinal rail 282 disposed along the bottom of the cap 220.

[0077] FIG. 15 shows the distal-to-proximal translation of the connecting member 266 (via the distal-to-proximal retraction of the release member 268 as described above). FIG. 15 shows that the distal-to-proximal translation of the connecting member 266 along the first longitudinal rail 280 and the second longitudinal rail 282 can shift the connecting member 266 from a locked configuration to an unlocked configuration, thereby enabling the connecting member 266 to be released from the hemostatic clip 218 as described above. As shown in FIG. 15, the distal-to-proximal translation of the connecting member 266 exposes the fixed protrusion 270 disposed on the connecting member 266.

[0078] The materials that can be used for various components of the medical device 10 disclosed herein and various other medical devices may be made from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, etc., or other suitable materials. Some examples of suitable polymers are polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block ester, polyurethane (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester copolymers (e.g., other polyester elastomers such as butylene / poly(alkylene ether) phthalate and / or HYTREL® available from DuPont), polyamide (e.g., DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamide, block polyamide / ether, polyether block amide (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyether imide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS AmericanGRILAMID® available from Grilon, perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomer, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, and polymer / metal composites thereof, etc. may be included. In some embodiments, the sheath may be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0079] Some examples of suitable metals and alloys include stainless steels such as 304V, 304L, and 316LV stainless steel, mild steel, nickel-titanium alloys such as linear elastic and / or superelastic nitinol, other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22®, UNS:N10276 such as HASTELLOY® C276®, and other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC® 400, and NICORROS® 400), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N®), nickel-molybdenum alloys (e.g., UNS:N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, and other nickel-tungsten or tungsten alloys, etc., cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as ELGILOY® and PHYNOX®), platinum-reinforced stainless steel, titanium, and combinations thereof, etc., or any other suitable materials.

[0080] In at least some embodiments, some or all of the medical device 10 and various other medical devices disclosed herein may also be doped with a radiopaque material, made of a radiopaque material, or include a radiopaque material. A radiopaque material is understood to be a material that can generate a relatively bright image with a fluoroscopic screen or another imaging technique during a medical procedure. This relatively bright image helps the user of the medical device 10 and the various other medical devices disclosed herein to determine the location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials filled with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils can also be incorporated into the design of the medical device 10 and the various other medical devices disclosed herein to achieve the same result.

[0081] It should be understood that the present disclosure is merely exemplary in many aspects. Without departing from the scope of the present disclosure, changes can be made in detail, particularly with regard to shape, size, and the arrangement of steps. This can include the use of any of the features of one exemplary embodiment used in other embodiments within an appropriate scope. The scope of the present disclosure is, of course, defined by the language in which the appended claims are expressed.

Claims

1. An endoscope comprising a shaft having a proximal region, a distal region, and an outer surface, a cap disposed along the distal region of the shaft of the endoscope, a hemostatic clip removably attached to the outer surface of the cap and configured to shift between an open position and a closed position, and a tension member coupled to the hemostatic clip A medical device comprising: actuation of the tension member shifts the hemostatic clip between the open position and the closed position, the hemostatic clip includes an upper jaw pivotable relative to a lower jaw, the tension member is coupled to a portion of the upper jaw, the upper jaw includes an opening, the tension member extends through the opening, further comprising a shearing member, the shearing member being coupled to the upper jaw, the tension member, or both the upper jaw and the tension member, and being coupled to the tension member at a welded connection, and by moving the shearing member relative to the tension member, cutting the welded connection and separating the tension member from the shearing member. A medical device.

2. An endoscope comprising a shaft having a proximal region, a distal region, and an outer surface, a cap disposed along the distal region of the shaft of the endoscope, a hemostatic clip removably attached to the outer surface of the cap and configured to shift between an open position and a closed position, and a tension member coupled to the hemostatic clip A medical device comprising: actuation of the tension member shifts the hemostatic clip between the open position and the closed position, the hemostatic clip includes an upper jaw pivotable relative to a lower jaw, the tension member is coupled to a portion of the upper jaw, the upper jaw includes an opening, the tension member extends through the opening, further comprising a shearing member, the shearing member being coupled to the upper jaw, the tension member, or both the upper jaw and the tension member, a rivet connects the shearing member to the tension member, and by moving the shearing member relative to the tension member, cutting the rivet and separating the tension member from the shearing member. A medical device.

3. The medical device according to claim 1 or 2, wherein when the upper jaw is pivoted relative to the lower jaw, the lower jaw is held in a fixed position.

4. The medical device according to claim 3, wherein the cap includes a first protrusion, and the hemostatic clip includes a curved portion configured to engage with the first protrusion.

5. The medical device according to claim 4, wherein a part of the shearing member engages with a part of the first protrusion.

6. The medical device according to claim 4, wherein the cap includes a connecting member configured to translate from a first position to a second position, and by shifting the connecting member from the first position to the second position, the hemostatic clip is released from the cap.

7. The medical device according to claim 6, further comprising a release member connected to the connecting member, and by retracting the release member, the connecting member is translated from the first position to the second position.

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