Medical devices for vascular hemostasis

Abstract

The medical instrument for endoscopic hemostasis of a blood vessel includes a handle (1), a sheath device (2) attached to the handle (1), a clamp device (3) including a clamp case (6) provided at a distal end of the sheath device (2) and at least two, specifically two clamp arms (8a, 8b), a control line (4) extending through the sheath device (2) and reversibly movable in a distal direction and a proximal direction, and an actuator (5) connected to a proximal end of the control line (4) and operable to reversibly move the control line (4) in a distal direction and a proximal direction, and the clamp arms (8a, 8b) are each connected to a distal end of the control line (4).

Description

[Technical field]

[0001] The present disclosure relates to a medical device for endoscopic hemostasis of a blood vessel. [Background technology]

[0002] Such medical devices are known, for example from EP 1 328 199 B1, and are used in particular for the treatment of gastrointestinal bleeding, in particular such devices are provided with clamps or clips for clamping a bleeding blood vessel, and are used to provide the vessel with a sufficient clamping force to restrict or interrupt the flow of blood passing therethrough.

[0003] The medical instrument known from EP 1 328 199 B1 comprises a handle and a sheath attached to the handle. A control line extends through the sheath and can be actuated by an actuator connected to a proximal end of the control line for reversibly moving the control line in a distal and proximal direction. The medical instrument further comprises a clamping device, which comprises a sleeve provided at the distal end of the sheath, and a clip having two clamping arms is connected to the distal end of the control line via a J-shaped hook. The clamping arms cooperate with the sleeve in such a way that when the control line is pulled in a proximal direction, the clamping arms engage with a front edge of the sleeve and are elastically deformed inwards to close, and when the control line is pushed in a distal direction, the clamping arms are pushed distally out of the sleeve and automatically open again due to their elastic restoring force. As the clamping device can be repeatedly opened and closed, the clamping device can be provided in a simple manner.

[0004] Once the clamping device is set in the correct position, the clamping arm must be locked closed. For this purpose, an opening is provided in the clamping arm into which a corresponding projection formed on the inner surface of the sleeve can engage. To lock the clamping arm closed, the control line is pulled in the proximal direction so that the projection engages the opening formed in the clamping arm.

[0005] The clamping device, including the clamping arm and the sleeve, can also be disconnected from other parts of the medical instrument. Thus, when the clamping device is fully closed, the control line is pulled back further to brake the J-hook and release the connection between the clamping arm and the control line. Pulling back further also operates the retainer connecting the control line to the sleeve, releasing the connection between the control line and the sleeve by the retainer. Summary of the Invention [Problem to be solved by the invention]

[0006] SUMMARY OF THE DISCLOSURE In view of the above prior art, it is an object of the present disclosure to provide a medical instrument of the above type that is not only easy to operate, but also easy to manufacture and assemble, and which operates reliably.

[0007] This object is solved by a medical instrument, in which the clamping case is directly and releasably connected to the connecting tube, such that the clamping case can rotate relative to the connecting tube about its longitudinal axis. [Means for solving the problem]

[0008] A medical device for vascular hemostasis, comprising: A handle and a sheath device attached to the handle; A clamping device including a clamp case provided at a distal end of the sheath device and at least two, specifically two, clamping arms; a control line extending through the sheath apparatus and reversibly movable in a distal direction and a proximal direction; an actuator connected to a proximal end of the control line and operable to reversibly move the control line in a distal direction and a proximal direction; The clamp arms are each connected to a distal end of a control line, and the clamp device is operable such that movement of the control lines opens and closes the clamp arms, such that proximal movement of the control lines translates to a closing movement of the clamp arms and distal movement of the control lines translates to an opening movement of the clamp arms; The sheath device includes a sheath, preferably an expandable coiled sheath, and a connecting tube defining a longitudinal axis and fixedly connected to a distal end of the sheath; The clamp case is directly and releasably connected to the connecting tube such that the clamp case can rotate about a longitudinal axis relative to the connecting tube.

[0009] The present disclosure is based on the idea of ​​providing the possibility to rotate the clamping device about its longitudinal axis relative to the sheath in order to improve the degree of freedom regarding the position at which the clamping arms can grip the tissue inside the human body. The placement of the clamping device inside the human body can thus be adapted to the orientation of the blood vessel to be clamped. The direct rotatable connection between the clamping case and the connecting tube leads to a compact design and a short construction length of the distal end of the medical instrument, since no intermediate elements are required between the clamping case and the connecting tube which is fixedly connected to the sheath.

[0010] The clamp case is therefore rotatable relative to a connecting tube formed at the distal end of the sheath arrangement, which connecting tube is fixed to the distal end of the sheath by a torque-resistant connection. Meanwhile, the clamp arm can be connected to the clamp case in a relatively rotationally fixed manner about its longitudinal axis. Furthermore, the clamp case is torque-resistantly connected to the control line, such that a rotation of the control line relative to the sheath arrangement also allows the clamp arm to rotate about its longitudinal axis, and the clamp case can rotate relative to the connecting tube of the sheath arrangement. Thus, the actuator and the handle are preferably designed to allow the control line to rotate about its longitudinal axis relative to the sheath arrangement.

[0011] According to a preferred embodiment of the present disclosure, the clamp case and the connecting tube are connected to each other by a push-in connection to form an overlapping portion between the connecting tube and the clamp case, the clamp case as the inner element being pushed into the connecting tube as the outer element, or the connecting tube as the inner element being pushed into the clamp case as the outer element, the overlapping portion of the inner element being formed with at least two through holes arranged with an angle offset in the circumferential direction, the overlapping portion of the outer element being formed with an inwardly facing annular groove, and at least one connecting element is provided which penetrates at least one through hole of the inner element and engages with the annular groove of the outer element to rotatably connect the clamp case to the sheath device relative to the connecting tube of the sheath device.

[0012] Thus, one of the two elements (i.e. the clamping case or the connecting tube) forming the outer or female element comprises an inwardly facing annular groove, and the other element forming the inner or male element comprises a through hole in the same axial region as the annular groove. A rotatable connection of both elements can be achieved by the connecting element passing through the through hole and engaged in the annular groove, since the connecting element is circumferentially fixed relative to the inner element by being engaged in the through hole, but rotatable relative to the outer element by being engaged in the annular groove. Such a connection saves space and allows a compact design of the distal end of the medical device.

[0013] The inner and outer elements are preferably designed to provide a clearance fit between the elements, so that the push-fit connection can be easily established and allows for rotation of the inner element relative to the outer element without the application of significant force or kinetic energy.

[0014] A release device may be provided which cooperates with each connection element and which, when the clamp arms are closed, in particular when the control lines are disconnected from the clamp device, can be operated by moving the control lines in a proximal direction so that the connection elements are disengaged from the annular grooves of the outer element, thereby releasing the clamp case from the sheath device. This design is based on the idea that after the clamp has been placed inside the body, the clamp case must be separated from the sheath device and the sheath device and the control lines arranged therein must be pulled outside the body through the working channel of the endoscope, whereby the clamp device remains inside the body.

[0015] Specifically, the medical device includes a connecting element having at least two, specifically two, circumferentially offset connecting arms, each of which is engaged with an annular groove formed in the outer element through a corresponding through hole formed in the inner element. Preferably, the connecting arms of the connecting element are configured to engage with the annular groove formed in the outer element with a longitudinal and radial clearance. In this way, the outer element can be easily rotated relative to the inner element without requiring a large kinetic energy or force, and the clamping case is releasably held on the connecting tube.

[0016] The connecting element can be formed as a disk having a central opening and at least two, in particular two, radially outwardly projecting connecting arms. Thus, the connecting element is provided as a disk having a central opening and two radially outwardly projecting connecting arms which pass through corresponding through holes formed in the inner element and engage in annular grooves formed in the outer element, and the entire connecting element can be formed as a planar disk.

[0017] Alternatively, the connection element comprises a proximal main part in the form of a disk with a central opening and at least two, in particular two, connecting arms extending distally from the proximal main segment, the distal end of which is formed with an engagement part extending radially outwardly through the through hole of the inner element and inserted into the annular groove formed in the outer element. In other words, the connection element comprises a main part having a constant thickness in the longitudinal direction and having a central opening through which the control line can pass, and a connecting arm extending distally from the main part. At the distal end of the connecting arm, the engagement part extends radially outwardly and projects into the through hole and into the annular groove. Due to such a longitudinal offset between the main part and the engagement part, the connection element is sufficiently elastic that it can be disengaged from the annular groove of the outer element by applying a small axial force in the proximal direction to the main part.

[0018] Furthermore, this type of connecting element may include two or more guide arms extending distally from the main portion, preferably circumferentially disposed between the connecting arms such that the connecting element is guided within the sheath device.

[0019] The release device may further include an intermediate tube surrounding the control line and disposed between the connection element and the connection head formed at the distal end of the control line, and when the control line moves in the proximal direction to close the clamp arm, the intermediate tube pushes the connection element in the proximal direction to release the clamp case from the connection tube, so that the connection element is disengaged from the annular groove formed in the outer element. In other words, the intermediate tube may be provided at the distal end of the control line, for example, between the distal end of the control line and the connection head. When the control line is pulled in the proximal direction to close the clamp arm, the intermediate tube is sandwiched between the distal end of the control line and the connection element. Thus, when the control line moves further in the proximal direction, the connection element is pushed proximally and the connection element is deformed to disengage from the annular groove of the connection arm. In particular, when the clamp case is released from the sheath device, the distal end of the connection arm may extend straight so that the engagement portion faces the distal side.

[0020] Alternatively, at least two, in particular two, connecting elements are provided in the form of elastically deformable connecting arms, the distal ends of the connecting elements being fixedly attached to the clamping case, and the proximal ends as free ends of the connecting elements forming engagement parts, each of which is engaged in an annular groove formed in the outer element through a corresponding through hole formed in the inner element. Contrary to the previously described embodiment, the connecting elements are fixedly connected to the clamping case. Each through hole formed in the inner element is assigned to one connecting element.

[0021] The release device is disposed in the containing connection element and includes a protrusion cooperating with the connection element, the protrusion presses the connection element to elastically deform it radially outward, so that the engagement portion of the connection element is pushed radially outward and engaged with the corresponding through hole and annular groove, the protrusion is connected to the control line, in particular, fixedly provided on the control line, and when the control line moves further in the proximal direction after the clamp arm is closed, the protrusion moves together with the control line to release the engagement with the connection element, whereby the connection element is deformed radially inward by its elastic restoring force, so that the engagement portion of the connection element is released from the corresponding annular groove of the outer element, and the clamp case is released from the sheath device. In other words, the connection element may be biased toward an inner position where it is released from the engagement with the corresponding ring groove of the outer element. The protrusions formed on the distal end of the control wire, in particular the protrusions formed by the connection heads formed on the distal end of the control wire, push the connection element to an outer position, where the engagement parts are engaged with the annular grooves formed on the outer element, thereby holding the clamp case at the distal end of the sheath device. When the control wire is pulled in the proximal direction to release the engagement of the protrusions with the connection element, the connection element is automatically deformed radially inward due to its elastic restoring force, and the engagement parts move radially inward to release the engagement with the corresponding annular grooves. In this way, the clamp case can be reliably released from the sheath device.

[0022] The distal end of the connecting element can be oriented radially outward and extend into a corresponding retaining hole in the clamping case. Preferably, the distal end of the connecting element is fixed to the connecting element by welding, in particular by spot welding. The connecting element has a straight portion continuing to the distal end of the connecting element, the straight portion being inclined inwardly with respect to the longitudinal axis of the clamping case, the inclination angle being preferably about 5°. The proximal end of the connecting element can be provided with an inwardly bulging portion.

[0023] The connecting tube and the sheath can be integrated together by welding, brazing, or pressing.

[0024] In accordance with further aspects of the present disclosure, the clamp arm may be retained on the distal end of the control line by a pivot pin that extends through a corresponding through hole in the proximal end of the clamp arm.

[0025] The pivot pins can protrude laterally on both sides from the distal ends of the clamp arms and the control wires and can be guided in the clamp case so that the pivot pins cannot rotate around the longitudinal axis of the clamp case. Specifically, the clamp case, which preferably defines the internal space, can have two slide grooves on its inner surface, which extend in the longitudinal direction and are arranged opposite each other so that the ends of the pivot pins engage in the slide grooves. In this way, it is ensured that the pivot pins cannot rotate relative to the clamp case around the longitudinal direction of the clamp case. In other words, a torque-resistant direction is realized between the pivot pins and the clamp case with respect to the longitudinal direction. The slide grooves can have a rectangular cross section.

[0026] Preferably, the clamp case includes two support arms extending distally from the clamp base, in particular extending sleeve-like, and the guide pin is in particular held between the two support arms, so that each clamp arm is provided with a guide groove, the guide grooves of the clamp arms partially overlap and a guide pin attached to the clamp case can extend through the overlapping portion of the guide grooves, such that due to the engagement of the guide pin with the guide groove, a proximal movement of the control wire is converted into a closing movement of the clamp arm and a distal movement of the control wire is converted into an opening movement about the pivot axis of the clamp arm.

[0027] The medical device further comprises a connection head at the distal end of the control line, the connection head including at least one pair of holding arms which can be moved between a fixed position and a release position, in which the holding arms surround the pivot pin and hold it in a particularly form-fitting manner, and in the release position the holding arms move away from each other to release the pivot pin. The connection head, in particular the holding arms of the connection head, can be accommodated by a holding groove formed in the clamp case. The holding arms are thus abutted against the side walls of the holding groove. In this way, a non-rotatable connection between the control line and the clamp case is realized by the pivot pin engaged in a slide groove formed in the connection head, preferably the clamp case, and the holding arms accommodated in the holding groove. Thus, when the control line is rotated relative to the sheath device by the actuator, the clamp case rotates and, as a result, the clamp arms rotate about the longitudinal axis of the connection tube. [Brief description of the drawings]

[0028] Hereinafter, embodiments of the present disclosure will be described with reference to the accompanying drawings. [Figure 1] FIG. 1 is a front view of a medical device according to a first embodiment of the present disclosure. [Diagram 2] 2 is an exploded view of the distal end of the medical device of FIG. 1. [Diagram 3] 2 is an exploded perspective view of the distal end of the medical device of FIG. 1. [Figure 4]2 is a cross-sectional view of the distal end of the medical instrument of FIG. 1 with the clamping arms opened. [Diagram 5] 2 is a cross-sectional view of the distal end of the medical instrument of FIG. 1 with the clamp arms open in another cross-sectional view. [Figure 6] 2 is another cross-sectional view of the distal end of the medical instrument of FIG. 1 with the clamp arms opened. [Figure 7] 2 is a cross-sectional view of the clamp base and pivot pin of the medical instrument of FIG. 1 with the clamp arms opened. [Figure 8] 2 is a cross-sectional view of the medical instrument of FIG. 1 with the clamping arms closed. [Figure 9] 2 is a cross-sectional view of the distal end of the medical instrument of FIG. 1 with the clamping arms closed in another cross-sectional view. [Figure 10] 1 is a cross-sectional view of a distal end of a medical instrument according to claim 1 having a clamping arm in a closed position. [Figure 11] 2 is a cross-sectional view of the clamp base and pivot pin of the medical instrument of FIG. 1 with the clamp arms closed. [Figure 12] 2 is a cross-sectional view of the distal end of the medical instrument of FIG. 1 with the clamp arms locked in a closed position in another cross-sectional view. [Figure 13] FIG. 13 is a cross-sectional view of a distal end of a medical instrument with clamp arms locked in a closed position in another cross-sectional view. [Figure 14] 1 is a cross-sectional view of a distal end of the medical instrument of claim 1 with the clamp arms locked in a closed position. [Figure 15] 2 is a cross-sectional view of the clamp base and pivot pin of the medical instrument of FIG. 1 with the clamp arms locked in a closed position. [Figure 16] FIG. 13 is a partial perspective view of a distal end of a control line and a clamp arm. [Figure 17] 1 is a partial perspective view of a distal end of a medical instrument with a clamping device released from a sheath device. FIG. [Figure 18] FIG. [Figure 19] FIG. [Figure 20] FIG. 11 is another vertical cross-sectional view of the clamp base. [Figure 21] FIG. [Figure 22] FIG. 13 is a side view of a distal end of a control line with a coupling head. [Figure 23] FIG. 13 is a plan view of the distal end of a control line. [Figure 24] FIG. 2 is a side view of the clamp arm of the instrument of FIG. 1. [Diagram 25] 2 is a partial cross-sectional view of the distal end of the medical device of FIG. 1. [Figure 26] 2 is a partially exploded view of the distal end of the medical instrument of FIG. 1, showing the clamp base and release mechanism of the sheath arrangement. [Figure 27] FIG. 13 is a partial cross-sectional view of a distal end of a medical instrument according to a second embodiment of the present disclosure, showing a sheath arrangement, a connecting element, and a clamp base. [Figure 28] 28 is a partially exploded view of the distal end of the medical device of FIG. 27. [Figure 29] FIG. 13 is a partial cross-sectional view of a distal end of a medical instrument according to a third embodiment of the present disclosure, showing a sheath arrangement, a connecting element, and a clamp base. [Diagram 30] 30 is a partially exploded view of the distal end of the medical device of FIG. 29. [Diagram 31] FIG. 13 is a partial cross-sectional view of a distal end of a medical instrument according to a fourth embodiment of the present disclosure, showing a sheath arrangement, a connecting element, and a clamp base. [Diagram 32] 32 is a partially exploded view of the distal end of the medical device of FIG. 31. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] 1-26 illustrate a first embodiment of a medical device according to the present disclosure, which is used to provide a clamp for hemostasis in blood vessels along the gastrointestinal tract, and the clamp is delivered to a target site via an endoscope.

[0030] The medical instrument includes a handle 1, a sheath device 2 attached to the handle 1, and a clamp device 3 provided at the distal end of the sheath device 2. A control line 4 extends through the sheath device 2 and is connected at its proximal end to an actuator 5 that is slidably held in the handle 1 and can reversibly move the control line 4 in distal and proximal directions by actuating the actuator. The actuator 5 and the handle 1 are designed such that the control line 4 can rotate about its longitudinal axis relative to the sheath device 2.

[0031] The clamping device 3 comprises a clamp case 6 having a clamp base 7 formed as a sleeve and two clamp arms 8a, 8b each connected to the distal end of a control line 4. In particular, the two clamp arms 8a, 8b are separate elements / members connected to the control line 4 by means of a tubular pivot pin 9. For this purpose, the pivot pin 9 extends through corresponding through holes 10 provided in the proximal end sections of the clamp arms 8a, 8b and is detachably held by a coupling head 11 formed on the distal end of the control line 4.

[0032] The two clamp arms 8a, 8b are connected to the distal end of the control line 4 and can be opened and closed by rotating around a common pivot axis formed by a pivot pin 9. Each clamp arm 8a, 8b is provided with a guide groove 12, and the guide grooves 12 of the clamp arms 8a, 8b partially overlap each other. Each guide groove 12 includes a proximal curved section 12a and a distal straight section 12b. The clamp device 3 further includes a guide pin 13 attached to the clamp case 6 and passing through the overlapping portion of the guide grooves 12. Due to the engagement between the guide pin 13 and the guide groove 12, the movement of the control line 4 in the proximal direction is converted into a closing movement of the clamp arms 8a, 8b, and the movement of the control line 4 in the distal direction is converted into an opening movement of the clamp arms 8a, 8b around the pivot axis. In this embodiment, the guide pin 13 is held between two support arms 14a, 14b of the clamp case 6 that extend distally from the clamp base 7 to form a bifurcated structure, and the clamp arms 8a, 8b are disposed between these support arms 14a, 14b. The clamp case 6 has an interior space defined by a central passage opening 15 formed in the clamp base 7 and the space between the support arms 14a, 14b.

[0033] Two slide grooves 16 are provided on the inner surface of the clamp case 6, extending in the longitudinal direction of the clamp case 6 and arranged opposite to each other so as to engage with the ends of the pivot pins 9. The slide grooves 16 have a rectangular cross section.

[0034] As shown in Figs. 12 to 15, the clamp case 6 is provided with two locking projections 17 in order to lock the clamp arms 8a and 8b in a closed state. The locking projections 17 protrude from the bottom of each slide groove 16 into the slide groove 16 and extend over the entire width of each slide groove 16. The locking projections 17 are designed to allow the pivot pin 9 to pass in a proximal direction but prevent the pivot pin 9 from passing in a distal direction in order to lock the clamp arms 8a and 8b in a closed state. For this purpose, each locking projection 17 has an inclined surface 18 on its distal side that has an inclination angle of 45° with respect to the longitudinal direction X of the clamp base 7, and a vertical surface 19 on its proximal side that extends perpendicular to the longitudinal direction X.

[0035] The medical instrument further includes a release device that locks the clamp arms 8a, 8b in a closed position and allows disengagement of the clamp arms 8a, 8b from the control line 4 when the control line 4 is pulled further in a proximal direction.

[0036] For this purpose, the coupling head 11 has a bifurcated holding structure including two pairs of holding arms 20a, 20b arranged on opposite lateral sides of the clamp arms 8a, 8b. The holding arms 20a, 20b are movable between a fixed position, for example shown in Figs. 4 to 11, and a released position, for example shown in Figs. 12 to 15. In the fixed position, the holding arms 20a, 20b surround the pivot pin 9 and hold it in a form-fitting manner. Specifically, recesses 21 having a semicircular cross section are formed on the opposing faces of the holding arms 20a, 20b. The pivot pin 9 is held in these recesses 21 in the fixed positions of the holding arms 20a, 20b. In the released position, the holding arms 20a, 20b move away from each other to release the pivot pin 9. The holding arms 20a, 20b are biased toward the released position. As shown particularly in Figures 2 and 3, the coupling head 11 is formed by a sheet member 11a forming two pairs of retaining arms and an extruded tube 11b, and the proximal portion of the sheet member 11a is connected to the control line 4 via the extruded tube 11b.

[0037] Due to the cooperation of the inner contour of the clamp case 6 with the retaining arms 20a, 20b, the retaining arms 20a, 20b are pressed towards each other into a fixed position as the retaining arms 20a, 20b move towards the distal part of the clamp case 6. The inner contour of the clamp case 6 comprises a retaining groove 22 assigned to each pair of retaining arms 20a, 20b, which retaining groove 22 opens towards the distal end of the clamp case 6. A total of two retaining grooves 22 with a rectangular cross section are therefore located on opposite sides of the internal space of the clamp case 6. The retaining grooves 22 receive the retaining arms 20a, 20b between their side walls, such that as the retaining arms 20a, 20b move into the retaining grooves 22, the retaining arms 20b abut against the side walls and are pressed against their restoring force into a fixed position.

[0038] The retaining groove 22 extends to a proximal enlarged portion 23 of the clamp case 6, which has an enlarged opening size compared to the retaining groove 22. The transition between the proximal enlarged portion 23, which has a substantially rectangular cross section, and the retaining groove 22 is formed as a step portion 24. The proximal enlarged portion 23 extends to the central passage opening 15 and the proximal portion of the support arms 14a, 14b. Thus, the retaining arms 20a, 20b automatically return to the release position by their restoring forces when the control line 4 is pulled in the proximal direction and the retaining arms 20a, 20b reach the proximal enlarged portion 23.

[0039] The step 24 is positioned relative to the locking projection 17 such that the pivot pin 9 passes the locking projection 17 before the retaining arms 20a, 20b of the coupling head 11 reach the proximal enlargement 23 and return to the release position. Specifically, the step 24 is positioned distal to the locking projection 17. Thus, the retaining arms 20a, 20b return to their release position before the guide pin 13 reaches the distal end of the straight portion 12b of the guide groove 12.

[0040] The sheath device 2 includes a coiled sheath 25 connected to the handle 1 and a connecting tube 26 fixedly connected to the distal end of the sheath 25, the sheath 25 and the connecting tube 26 being welded to form an inseparable unit.

[0041] The clamping case 6 is directly and detachably connected to the connecting tube 26 such that the clamping case 6 is rotatable about its longitudinal axis relative to the connecting tube 26. In particular, this connection is realized by a push-fit connection, whereby an overlapping portion 27 of the connecting tube 26 and the clamping case 6 is formed. In the embodiment shown in Figures 1 to 26, the clamping case 6 is pushed into the connecting tube 26 such that the clamping case 6 forms the inner element and the connecting tube 26 forms the outer element. Two through holes 28 are formed in the overlapping portion 27 of the clamping case 6, and corresponding annular grooves 29 facing inwards are formed in the overlapping portion 27 of the connecting tube 26.

[0042] In order to connect the clamp case 6 to the sheath device 2 and to enable the clamp case 6 to rotate relative to the connection tube 26 of the sheath device 2, one connection element 30 is provided which penetrates the through hole 28 and engages with the annular groove 29. Specifically, the connection element 30 includes a disk-shaped proximal main portion 31 having a central opening 32. The control wire 4 penetrates this central opening 32. Two connection arms 33 arranged opposite each other in the circumferential direction extend distally from the main portion 31, and an engagement portion 34 is formed at the distal end of the connection arm 33, and this engagement portion 34 extends radially outward and penetrates the through hole 28 to engage in the annular groove 29. Furthermore, the connection element 30 includes two guide arms 35 which extend distally from the main portion 31. The guide arms 35 are arranged between the connection arms 33 in the circumferential direction.

[0043] A release device is provided which cooperates with the connection element 30 and which can be actuated by moving the control line 4 in a proximal direction such that it disengages from the annular groove 29 of the connection tube 26 of the connection element 30 when the clamping arms 8a, 8b are closed and the control line 4 is disconnected from the clamping device 3. In particular, the release device includes a central tube 36 which surrounds the control line 4 and is disposed between the connection element 30 and the coupling head 11 of the control line 4.

[0044] The central tube 36 is designed to press against the main part 31 of the connection element 30. Thus, the central tube 36 can press the connection element 30 in the proximal direction when the control line 4 moves in the proximal direction to close the clamp arms 8a, 8b. In this way, the engagement part 34 can disengage from the annular groove 29 formed in the connection tube 26, thereby releasing the clamp case 6 from the connection tube 26, as illustrated in FIG.

[0045] In use, the clamping device 3 is delivered to a target site by an endoscope and secured to the blood vessel at a predetermined position at the target site. To this end, the clamping device 3 can be rotated relative to the sheath apparatus 2 by rotating the control line 4 relative to the sheath apparatus 2. To clamp the blood vessel, the clamping arms 8a, 8b can be repeatedly opened and closed by moving the control line 4 in distal and proximal directions with the actuator 5.

[0046] To improve the gripping of tissue located between the clamping arms 8a, 8b and to minimize the risk of loosening of the clamping device 3 when fixed to tissue inside the patient's body, each clamping arm 8a, 8b includes two barbs 37a, 37b, 37c, 37d arranged on the gripping portion 38 on opposite laterally opposite sides of the clamping arm 8a, 8b. The barbs 37a, 37b, 37c, 37d are formed such that each barb faces the corresponding opposite barb of the other clamping arm 8a, 8b. For example, it can be seen from FIG. 24 that the clamping arm 8b includes two barbs 37c, 37d facing the other clamping arm 8a. The barb 37c includes a clamping profile in the form of a V-shaped projection 39, and the barb 37d includes a clamping profile in the form of a V-shaped recess 40 complementary to the V-shaped projection 39. Barb 37a of clamp arm 8a has a V-shaped recess 40, and barb 37b has a V-shaped protrusion 39, each complementary to a corresponding barb 37c, 37d of the other clamp arm 8b. To avoid unintentional damage to the blood vessel sandwiched between clamp arms 8a, 8b, the corners of V-shaped protrusion 39 and V-shaped recess 40 are rounded. Rounded recesses 41 are provided adjacent barbs 37a, 37b, 37c, 37d.

[0047] The distal end of the gripping portion 38 of each clamp arm 8a, 8b is bent inwardly toward the other clamp arm 8a, 8b. The distal end of each clamp arm 8a, 8b is formed with an engagement contour 42 (in this example, a zigzag contour). The engagement contours 42 of the clamp arms 8a, 8b are complementary to each other such that they interlock when the clamp arms 8a, 8b are closed.

[0048] When the clamping device 3 is set, the clamping arms 8a, 8b are locked in the closed state. For this purpose, the control wire 4 is pulled in the proximal direction, and the pivot pin 9 engaged in the slide groove 16 passes through the locking projection 17 and is elastically deformed. When the pivot pin 9 passes through the locking projection 17, the surface 19 extending perpendicularly to the longitudinal direction X prevents the pivot pin 9 from passing again in the distal direction. In this way, the clamping arms 8a, 8b can be prevented from being opened again unintentionally.

[0049] As a next step, the clamp arms 8a, 8b are disconnected from the control line 4. For this purpose, the control line 4 is pulled further in the proximal direction so that the holding arms 20a, 20b reach the proximal enlargement 23 of the clamp case 6. The holding arms 20a, 20b expand due to their elastic restoring force, releasing the pivot pin 9 from the recess 21 formed in the holding arms 20a, 20b.

[0050] To separate / release the clamp case 6 from the sheath device 2, the control line 4 is pulled back further in the proximal direction. As a result, the central tube 36 is pressed between the coupling head 11 of the control line 4 and the connection element 30, so that the connection element 30 is pressed in the proximal direction. In this manner, the engagement portion 34 formed on the connection arm 33 is disengaged from the annular groove 29 of the connection tube 26 and the through hole 28 of the clamp case 6, whereby the clamp case 6 is released from the connection tube 26 of the sheath device 2.

[0051] 27 and 28 show a second embodiment of a medical device according to the present disclosure.

[0052] This medical device is very similar to the medical device disclosed in Figures 1 to 26 and differs from this embodiment only in that the clamp case 6 is not pressed into the connecting tube 26 fixedly connected to the distal end of the sheath 25, but rather the clamp case 6 forming the outer element is pressed into the connecting tube 26 to form the inner element. Thus, the connecting tube 26 is formed with two through holes 28 arranged opposite each other, and the clamp case 6 is formed with an annular groove 29 facing inwards.

[0053] 1 to 26, the engaging portion 34 of the connecting arm 33 penetrates the through hole 28 of the connecting tube 26 and engages with the annular groove 29 of the clamp case 6. In this manner, the clamp case 6 can be rotated relative to the sheath device by rotating the control wire 4.

[0054] 29 and 30 show a third embodiment of the medical device according to the present disclosure. This medical device is very similar to the medical device disclosed in FIGS. 1 to 26, but the connection element 30 is different from the connection element in the medical device of FIGS. 1 to 26. The connection element 30 is formed as a flat disk having a central opening 32 and two connection arms 33 protruding radially outward. As shown in FIG. 29, the connection arms 33 are disposed on the same plane as the disk and are engaged with an annular groove 29 formed in the connection tube 26 through a through hole 28 formed in the clamp case 6.

[0055] To release the clamp case 6 from the connecting tube 26, the connecting element 30 is pressed in the proximal direction by the coupling head 11 of the control line 4, whereby the connecting element 30 is deformed and disengaged from the annular groove 29 of the connecting arm 33.

[0056] 31 and 32 show another embodiment of a medical device according to the present disclosure.

[0057] This medical device is substantially the same as that described above. However, the sheath device 2 is connected to the clamp case 6 by two connection elements 30 in the form of elastic connection arms positioned on opposite sides of the clamp case 6. In particular, the distal end of the connection element 30 is fixedly attached to the clamp case 6, and the proximal end, which is the free end of the connection element 30, forms an engagement portion 34 that engages with a corresponding engagement means provided on the inner circumferential surface of the connection tube 26 in order to connect the clamp case 6 to the sheath device 2. Here, the clamp case 6 is connected to the sheath device 2 by a push-in connection in which the proximal end of the clamp case 6 is inserted into and extends through the distal end of the connection tube 26. Through holes 28, which are arranged opposite to each other at the overlapping portion of the connection tube 26, are formed in the clamp case 6, and a corresponding annular groove 29 is formed in the connection tube 26. The engagement portions 34 of the connection elements 30 are inserted through the through holes 28 of the clamp case 6 and into the annular groove 29 of the connection tube 26, thereby connecting the clamp case 6 to the sheath device 2.

[0058] The connection element 30 has an inwardly bulging portion that bulges inward. The distal end of the connection element 30 extends radially outward into a corresponding retaining hole 43 in the clamp case 6 and is fixed in the retaining hole 43 by welding, preferably by spot welding. The connection element 30 further has a straight portion 44 continuing from the distal end of the connection element 30, the straight portion 44 being inclined inwardly at an inclination angle of 5° with respect to the central longitudinal axis of the clamp case. An inwardly bulging portion 45 is provided at the proximal end of the connection element 30 between the straight portion 44 and the engagement portion 34 of the connection element 30.

[0059] A release device is provided for releasing the connection between the clamp case 6 and the connection tube 26. The release device includes a protrusion 46 formed by the coupling head 11 provided at the distal end of the control line 4. The protrusion 46 is located between the inwardly bulging portions 45 and presses the free end of the connection element 30 such that the inwardly bulging portions 45 are elastically deformed outward by cooperation with the inwardly bulging portions 45 of the connection element 30. When the control line 4 is pulled proximally and the cooperation between the protrusion 46 and the connection element 30 is released, the inwardly bulging portions 45 are elastically deformed inward by an elastic restoring force and restored to their original shape, and the engagement portion 34 is released from the annular groove 29 formed in the connection tube 26. [Explanation of symbols]

[0060] 1 Handle 2. Sheath device 3 Clamping device 4 Control Line 5 Actuators 6 Clamp case 7 Clamp Base 8a, 8b Clamp arms 9 Pivot Pin 10 Through hole 11 Coupling head 11a Sheet-like member 11b Pressure tube 12 Guide groove 12a Curved section 12b Straight section 13 Guide pin 14a, 14b Support arms 15 Center passage opening 16 Slide groove 17 Lock protrusion 18 Slope 19 sides 20a, 20b Holding arms 21 Recess 22 Retaining groove 23 Proximal expansion 24 Step 25 Sheath 26 Connecting pipe 27 Overlap 28 Through hole 29 Annular groove 30 Connection member 31 Main Section 32 Center opening 33 Connecting arm 34 Engagement part 35 Guide Arm 36 Central canal 37a~d Barb 38 Gripping part 39 V-shaped process 40 V-shaped recess 41 Rounded recess 42 Engagement profile 43 Retaining hole 44 Straight section 45 Inward bulge 46 Protrusion X Longitudinal direction

Claims

1. A handle (1); a sheath device (2) attached to the handle (1); a clamping device (3) including a clamp case (6) provided at the distal end of the sheath device (2) and at least two, specifically two, clamping arms (8a, 8b); a control line (4) extending through the sheath device (2) and reversibly movable in a distal direction and a proximal direction; an actuator (5) connected to a proximal end of the control line (4) and operable to reversibly move the control line (4) in the distal and proximal directions; the clamping arms (8a, 8b) are each connected to a distal end of the control line (4), and the clamping device (3) is operable such that movement of the control line (4) causes the clamping arms (8a, 8b) to open and close, such that movement of the control line (4) in a proximal direction is translated into a closing movement of the clamping arms (8a, 8b) and movement of the control line (4) in a distal direction is translated into an opening movement of the clamping arms (8a, 8b); The sheath device (2) includes a sheath (25), preferably an expandable coiled sheath (25), and a connecting tube (26) defining a longitudinal axis and fixedly connected to a distal end of the sheath (25); A medical device for vascular hemostasis, characterized in that the clamp case (6) is directly and releasably connected to the connecting tube (26) so as to be rotatable about the longitudinal axis relative to the connecting tube (26).

2. The clamp case (6) and the connecting pipe (26) are connected to each other by a push-in connection, and an overlapping portion (27) between the connecting pipe (26) and the clamp case (6) is formed; The clamp case (6) as an internal element is pushed into the connecting tube (26) as an external element, or the connecting tube (26) as an internal element is pushed into the clamp case (6) as an external element; The overlapping portion (27) of the inner element has at least two through holes (28) that are angularly offset in the circumferential direction, and the overlapping portion (27) of the outer element has an inwardly directed annular groove (29); 2. The medical device according to claim 1, characterized in that at least one connecting element (30) is provided which passes through at least one through hole (28) of the inner element and engages with the annular groove (29) of the outer element to rotatably connect the clamp case (6) to the sheath device (2) relative to the connecting tube (26).

3. A release device is provided which cooperates with each connection element (30); 3. The medical instrument according to claim 2, characterized in that, when the clamp arms (8a, 8b) are closed and in particular the control line (4) is disengaged from the clamp device (3), the release device is operable by moving the control line (4) in the proximal direction, whereby the connection element (30) is disengaged from the annular groove (29) of the outer element and the clamp case (6) is released from the sheath device (2).

4. 4. The medical device according to claim 3, characterized in that the medical device comprises one connection element (30) having at least two, specifically two, connection arms (33) arranged at a certain angular offset in the circumferential direction, each connection arm (33) passing through a corresponding through hole (28) formed in the inner element and engaging with the annular groove (29) formed in the outer element.

5. 5. The medical device according to claim 4, characterized in that the connection element (30) is formed in the shape of a disk and has a central opening (32) and at least two, in particular two, connection arms (33) projecting radially outwardly.

6. 5. The medical device according to claim 4, characterized in that the connection element (30) has a disk-shaped proximal main portion (31) having a central opening (32), and at least two, specifically two, connection arms (33) extending distally from the proximal main portion (31), and an engagement portion (34) is formed at the distal end of the connection arm (33) extending radially outward and passing through the through hole (28) of the inner element to be inserted into the annular groove (29) formed in the outer element.

7. the release device includes an intermediate tube (36) surrounding the control line (4) and disposed between the connection element (30) and a connection head (11) formed at the distal end of the control line (4); 7. The medical device according to claim 5 or 6, characterized in that, when the control line (4) is moved in the proximal direction to close the clamp arms (8a, 8b), the intermediate tube (36) pushes the connection element (30) in the proximal direction so as to disengage the connection element (30) from the annular groove (29) formed in the outer element, thereby releasing the clamp case (6) from the connection tube (26).

8. At least two, in particular two, connecting elements (30) are provided in the form of elastically deformable connecting arms (33), A distal end of the connecting element (30) is fixedly attached to the clamp case (6); The medical device according to claim 3, characterized in that the proximal end as a free end of the connecting element (30) forms an engagement portion (34), each of which is engaged with the annular groove (29) formed in the outer element through a corresponding through hole (28) formed in the inner element.

9. the release device is disposed within the connection element (30) and includes a protrusion (46) cooperating with the connection element (30), and the protrusion presses against the connection element (30) to elastically deform it radially outward, whereby the engagement portion (34) of the connection element (30) is pushed radially outward to engage with the corresponding through hole (28) and the annular groove (29); The protrusion (46) is connected to the control line (4), in particular fixedly attached to the control line (4); 9. The medical device according to claim 8, characterized in that when the control wire (4) is further moved in the proximal direction after the clamp arms (8a, 8b) are closed, the protrusion (46) moves together with the control wire (4) and disengages from the connection element (30), whereby the connection element (30) is deformed radially inward due to its elastic restoring force, and the engagement portion (34) of the connection element (30) is disengaged from the corresponding annular groove (29) of the outer element, thereby releasing the clamp case (6) from the sheath device (2).

10. 10. The medical device according to claim 9, characterized in that the protrusion (46) is formed by a connection head (11) formed at the distal end of the control line (4).

11. 2. The medical device according to claim 1, wherein the connecting tube (26) and the sheath (25) are integrated together by welding, brazing or pressing.

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