Medical devices for vascular hemostasis
Patent Information
- Application Number
- JP2024600140U
- Authority / Receiving Office
- JP · JP
- Patent Type
- Utility models
- Current Assignee / Owner
- Filing Date
- 2022-02-25
- Publication Date
- 2025-03-05
- Estimated Expiration
- 2032-02-25
Smart Images
Figure 0003250413000001_ABST
Abstract
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. [Means for solving the problem]
[0007] This object is solved by the following medical instrument, namely, a pivot pin protrudes laterally on both sides from the distal end of the clamp arm and the control line, and the clamp case is provided with two locking protrusions which extend into the internal space of the clamp case and are designed to allow the pivot pin to pass in the proximal direction but prevent the pivot pin from passing in the distal direction in order to lock the clamp arm in the closed state.
[0008] The medical device for vascular hemostasis comprises: A handle and a sheath device attached to the handle; a clamping device including a clamping case defining a longitudinal direction, the clamping case having a clamping base in the form of a sleeve provided at the distal end of the sheath device and at least two, specifically two, clamping arms, the clamping case defining an interior space; 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 to open and close the clamp arms by movement of the control lines, 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 clamp arm is openably held to the distal end of the control line by a pivot pin extending through a corresponding through hole in the proximal end portion of the clamp arm; The pivot pins project laterally on either side of the distal ends of the clamp arms and the control wires; The clamp case is provided with two locking protrusions that extend into the interior space of the clamp case and are designed to permit proximal passage of the pivot pin but prevent distal passage of the pivot pin to lock the clamp arm in a closed position.
[0009] The present disclosure provides a locking protrusion protruding into the internal space of the clamp case in consideration of the following. As a result, when the pivot pin passes through the locking protrusion, the pivot pin is locked proximally relative to the locking protrusion. In this way, stable and reliable locking of the clamp arm in the closed state can be achieved. Preferably, the pivot pin passes through the locking protrusion with its end face in contact with the locking protrusion. As a result, the locking protrusions can be provided on both opposing sides of the internal space. As a result, when the pivot pin overcomes the locking protrusion by elastic deformation and passes through the locking protrusion, it can restore to its original shape.
[0010] According to one preferred embodiment of the present disclosure, each locking projection has an inclined surface at its distal side, which is inclined with respect to the longitudinal direction of the clamp case, and a vertical surface at its proximal side, which extends perpendicular to the longitudinal direction. Preferably, the inclined surface has an inclination angle of at least 30° and / or at most 60°, preferably 45°, with respect to the longitudinal direction of the clamp case. Thus, the locking projection has an inclined surface at its distal side, which causes the internal space to taper in this region, thereby allowing the pivot pin to pass through the locking projection by elastic and / or plastic deformation. As the proximal surface of the locking projection extends perpendicular to the longitudinal direction, once the pivot pin has passed through the locking projection, it is not possible for the pivot pin to pass from the proximal to the distal direction. In this way, the pivot pin is safely locked proximally to the locking projection, which holds the clamp arm in the closed state.
[0011] The pivot pin is preferably tubular so as to allow elastic and / or plastic deformation of the pivot pin when the locking projection passes through it. The pivot pin may be made of a metallic material (especially stainless steel) or a plastic material.
[0012] According to a further embodiment, the inner surface of the clamping case is provided with two slide grooves extending along the longitudinal direction, which are arranged opposite each other so that the ends of the pivot pin engage in the slide grooves. In this way, it is ensured that the pivot pin cannot rotate relative to the clamping case around the longitudinal direction of the clamping case. In other words, a torsional connection between the pivot pin and the clamping case in the longitudinal direction is realized. The slide grooves can have a rectangular cross section.
[0013] The locking protrusion protrudes into the corresponding slide groove from the bottom of the slide groove. Therefore, the locking protrusion can be completely positioned in the slide groove. This prevents the locking protrusion from interfering with other members that are positioned or moved in the internal space of the clamp case. According to one preferred embodiment, the locking protrusion extends over the entire width of the corresponding slide groove.
[0014] The clamp arm is provided as a separate element and is pivotally connected to the distal end of the control line about a common pivot axis defined by a pivot pin.
[0015] Preferably, the clamp case includes two support arms extending distally from the clamp base, and in particular the guide pin is held between the two support arms, such that each clamp arm is provided with a guide groove, the guide grooves of the clamp arms partially overlap each other, and the guide pin attached to the clamp case can extend through the guide groove at the overlapping portion of the guide groove, whereby, by engagement of the guide pin with the guide groove, proximal movement of the control wire is translated into a closing movement of the clamp arm, and distal movement of the control wire is translated into an opening movement about the pivot axis of the clamp arm.
[0016] The clamp case includes a central passage opening, particularly in the clamp base, which preferably has a rectangular cross section, such that the interior space of the clamp case is defined by the central passage opening and the space between the support arms.
[0017] Also, provide a release device that allows the clamp arm to disconnect from the control line when the clamp arm is locked in the closed state and the control line is pulled further in the proximal direction. In other words, when the clamp arm is in the closed state, the clamp arm can be disconnected from the control line and the clamp device must be ensured to be released from the rest of the medical instrument.
[0018] Specifically, the control line includes a coupling head at its distal end, the coupling head including at least one pair of retaining arms movable between a fixed position and a released position, where in the fixed position the retaining arms surround the pivot pin to hold it in a form-fitting manner, and in the released position the retaining arms move away from each other to release the pivot pin, the retaining arms are biased toward the released position, and due to cooperation between the inner contour of the clamp case and the retaining arms, the retaining arms are urged toward each other to the fixed position as long as the retaining arms extend to the distal portion of the clamp case, and when the control line is pulled in the proximal direction and the retaining arms reach the proximal portion of the clamp case, the retaining arms automatically return to the released position.
[0019] In other words, the distal end of the control line is provided with a specific coupling head, which includes at least two retaining arms that, when the clamp arm is connected to the control line, are engaged around a pivot pin that protrudes laterally from the clamp arm. As the retaining arms move to the distal part of the clamp case, the retaining arms of the coupling head of the control line are automatically held in a fixed position. When the clamp arm is locked in a closed state and the control line is further pulled back, the retaining arms reach the proximal part, in particular the proximal enlarged part, which has an enlarged opening size compared to the proximal part, in particular the distal part. Due to the elastic restoring force of the retaining arms, they dynamically return to the release position when they reach the proximal enlarged part of the clamp case, releasing the pivot pin.
[0020] In particular, the inner contour of the clamping case includes a retaining groove assigned to each pair of retaining arms, which receives the retaining arms between its side walls and holds them in a fixed position against the side walls as the retaining arms move into the retaining grooves, each retaining groove extending to a proximal widening with an enlarged opening dimension compared to the retaining groove, and when the control line is pulled in the proximal direction and the retaining arms reach the proximal widening, the retaining arms automatically return to the release position. In other words, a retaining groove extending in the longitudinal direction of the clamping case, in particular with a rectangular cross section, is used to receive the retaining arms of the coupling head, which are held in a fixed position when the retaining arms are positioned in the retaining grooves. One of the pair of retaining arms thus abuts against one side wall of the retaining groove and the other retaining arm against the opposite side wall. The retaining arms are thus received in the retaining grooves in a very space-saving manner.
[0021] According to a further embodiment, the coupling head comprises two pairs of holding arms arranged on two laterally opposite sides of the clamping arm, and a corresponding holding groove is arranged on each side of the clamping arm in the clamping case. The coupling head has a U-shaped or bifurcated structure at its distal end.
[0022] Preferably, the slide groove is arranged in the retaining groove, in particular at the bottom of the retaining groove, so that the retaining grooves arranged opposite each other form a substantially rectangular, in particular square, cross section of the interior space of the clamping case, on two laterally opposite faces of which slide grooves for receiving the ends of the pivot pin are arranged.
[0023] The transition between the proximal extension and the retention groove is formed as a step. Such a step correlates with an immediate change in the opening size between the proximal extension and the retention groove, so that there is a limiting torque for disconnecting the pivot pin and the control line. Also, once the retention arm reaches the release position, it cannot return to the locking position. In this way, tampering with the medical device can be prevented.
[0024] Preferably, the step is arranged relative to the locking projection such that the locking projection passes over the pivot pin before the retaining arm of the coupling head reaches the proximal enlargement and returns to the release position. This embodiment is based on the idea that the clamping arm must first be locked in the closed state before it is separated from the control line. This ensures a safe and reliable operation. Therefore, the retaining arm, which has extended to a distal position of the pivot pin, must return to the release position after the pivot pin has passed over the locking projection. In particular, the step is arranged distal to the locking projection.
[0025] The opposing faces of the retaining arms are formed with recesses for receiving the pivot pin, the recesses preferably extending over the entire thickness of the respective retaining arm and / or preferably having an at least substantially semicircular cross section. In this way, a form-fitting connection between the retaining arms and the pivot pin can be achieved when the retaining arms are in the fixed position. The semicircular cross section of the recesses allows the pivot pin to pivot within the recesses.
[0026] According to a preferred embodiment of the present disclosure, each pair of retaining arms is formed with a one-piece design so that the retaining arms can be elastically deformed between a fixed position and a released position. In other words, the retaining arms of the pair of retaining arms are not formed as separate elements, but are formed as one member disposed at the distal end of the control line, and the retaining arms can be elastically deformed between a fixed position and a released position. [Brief description of the drawings]
[0027] [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. [Diagram 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
[0028] Hereinafter, embodiments of the present disclosure will be described with reference to the accompanying drawings.
[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 Retention 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 clamping case (6) defining a longitudinal direction (X), said clamping case (6) having a clamping base (7), in particular in the form of a sleeve, provided at the distal end of said sheath device (2) and at least two, in particular two, clamping arms (8a, 8b), said clamping case (6) defining an internal space; 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 a distal direction and a proximal direction; 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 clamp arms (8a, 8b) are openably and closably held to the distal ends of the control lines (4) by pivot pins (9) extending through corresponding through holes (10) provided at the proximal end portions of the clamp arms (8a, 8b); The pivot pins project laterally on either side at the distal ends of the clamp arms (8a, 8b) and the control wire (4); The medical device for vascular hemostasis, characterized in that the clamp case (6) is provided with two locking protrusions (17), which extend into an internal space of the clamp case (6), and the locking protrusions (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, 8b) in a closed state.
2. 2. The medical device for vascular hemostasis according to claim 1, characterized in that each locking projection (17) has, on its distal side, an inclined surface (18) inclined with respect to the longitudinal direction (X) of the clamp case (6), and, on its proximal side, a vertical surface (19) extending perpendicular to the longitudinal direction (X).
3. 3. The medical device for vascular hemostasis according to claim 2, characterized in that the inclined surface (18) has an inclination angle of at least 30° and / or at most 60°, preferably 45°, relative to the longitudinal direction (X) of the clamp case (6).
4. 10. Medical device for vascular hemostasis according to any one of the preceding claims, characterized in that the pivot pin (9) is tubular.
5. The medical device for vascular hemostasis according to any one of the above claims, characterized in that the inner surface (19) of the clamp case (6) is provided with two slide grooves (16) extending in the longitudinal direction (X), and the two slide grooves (16) are arranged opposite each other so that each end of the pivot pin (9) engages with one slide groove (16).
6. 6. The medical device for vascular hemostasis according to claim 5, wherein the locking protrusion (17) protrudes into the corresponding slide groove (16) from a bottom of the slide groove (16).
7. 7. Medical device for vascular hemostasis according to claim 5 or 6, characterized in that the slide groove (16) has a rectangular cross section.
8. 8. A medical device for vascular hemostasis according to claim 6 or 7, characterized in that the locking projection (17) extends over the entire width of the corresponding slide groove (16).
9. 10. The medical device for vascular hemostasis according to any one of the preceding claims, characterized in that the clamp case (6) comprises a central passage opening (15) and two support arms (14a, 14b) extending in a distal direction from the clamp base (7), and the internal space of the clamp case (6) is defined by the space between the central passage opening (15) and the support arms (14a, 14b).
10. A medical device for vascular hemostasis according to any one of the above claims, characterized in that a release device is provided which allows the connection between the clamp arms (8a, 8b) and the control line (4) to be released when the clamp arms (8a, 8b) are locked in the closed state and the control line (4) is pulled further in the proximal direction.
11. The control line (4) includes a coupling head (11) at its distal end, said coupling head (11) comprises at least one pair of retaining arms (20a, 20b) which are movable between a fixed position and a released position, in which said retaining arms (20a, 20b) surround said pivot pin (9) and retain said pivot pin (9) in a particularly form-fitting manner, and in which said released position said retaining arms (20a, 20b) move away from each other to release said pivot pin (9); The retaining arms (20a, 20b) are biased towards their release position; 11. The medical device for vascular hemostasis according to claim 10, characterized in that due to cooperation between the inner contour of the clamp case (6) and the holding arms (20a, 20b), the holding arms (20a, 20b) are pressed towards each other into a fixed position as the holding arms (20a, 20b) move towards the distal part of the clamp case (6), and when the control wire is pulled in the proximal direction and the holding arms (20a, 20b) reach the proximal part of the clamp case (6), the holding arms (20a, 20b) automatically return to the released position.
12. the inner contour of the clamping case (6) comprises a retaining groove (22) assigned to each pair of retaining arms (20a, 20b), said retaining groove (22) receiving said retaining arms (20a, 20b) between its side walls, and as said retaining arms (20a, 20b) move into said retaining groove (22), said retaining arms (20a, 20b) abut against said side walls and are held in a fixed position, 12. The medical device for vascular hemostasis according to claim 11, characterized in that each retaining groove (22) extends to a proximal enlarged portion (23) of the clamp case (6) having an enlarged opening dimension compared to the width of the retaining groove (22), and when the control line (4) is pulled in the proximal direction and the retaining arms (20a, 20b) reach the proximal enlarged portion (23), the retaining arms (20a, 20b) automatically return to the released position, and the proximal enlarged portion (23) has an enlarged opening dimension compared to the width of the retaining groove (22).
13. 13. The medical device for vascular hemostasis according to claim 12, characterized in that the coupling head (11) comprises two pairs of retaining arms (20a, 20b) arranged on two laterally opposite sides of the clamping arms (8a, 8b), each of which has one retaining groove (22) arranged on both sides.
14. 14. A medical device for vascular hemostasis according to claim 12 or 13, characterized in that the transition between the proximal enlargement (23) and the retaining groove (22) is formed as a step (24).
15. 15. The medical device for vascular hemostasis according to claim 14, characterized in that the step (24) is positioned relative to the locking projection (17) such that the pivot pin (9) passes through 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.
16. A medical device for vascular hemostasis according to any one of claims 12 to 15, characterized in that the slide groove (16) is arranged within the retaining groove (22), in particular at the bottom of the retaining groove (22).
17. A medical device for vascular hemostasis according to any one of claims 11 to 16, characterized in that the opposing faces (19) of the retaining arms (20a, 20b) are formed with recesses (21) for receiving the pivot pin (9), said recesses (21) preferably extending over the entire thickness of the corresponding retaining arm (20a, 20b) and / or preferably having an at least substantially semicircular cross section.
18. A medical device for vascular hemostasis according to any one of claims 11 to 17, characterized in that each pair of retaining arms is formed in an integral design such that the retaining arms (20a, 20b) are elastically deformable between a fixed position and a released position.
19. 10. A medical device for vascular hemostasis according to any one of the preceding claims, characterized in that the clamp arms (8a, 8b) are provided as separate elements and are pivotally connected to the distal end of the control line (4) about a common pivot axis defined by the pivot pin (9).