Medical instrument for blood vessel hemostasis

Abstract

A medical device for hemostasis of a blood vessel by an endoscope, comprising: a handle; a sheath device; a clamping device comprising a clamping housing defining a longitudinal axis, the clamping housing having a clamping base, in particular in the form of a sleeve, arranged on the distal end of the sheath device, and at least two, in particular exactly two clamping arms, said clamping housing defining an inner space; a control line extending through the sheath device and reversibly movable in a distal direction and a proximal direction; and an actuator coupled to the proximal end of the control wire and actuatable to reversibly move the control wire in distal and proximal directions; wherein the clamp arms are each coupled to a distal end of the control line and the clamp device is actuatable to open and close the clamp arms.

Description

Technical Field

[0001] The present disclosure relates to a medical device for stopping bleeding of a blood vessel through an endoscope. Background Art

[0002] Such medical devices are known, for example, from EP 1328199 B1 and are particularly used for treating gastrointestinal bleeding. Specifically, such devices are used to provide forceps or clamps to clamp a bleeding vessel, thereby applying sufficient constriction force to the vessel to limit or interrupt blood flow therethrough.

[0003] The medical device known from EP 1328199 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, which is coupled to the proximal end of the control line to reversibly move the control line in the distal and proximal directions. The medical device also comprises a clamp device, which comprises a sleeve arranged on the distal end of the sheath, and a clamp with two clamp arms is coupled to the distal end of the control line by a J-hook. The clamp arms cooperate with the sleeve in such a way that when the control line is pulled in the proximal direction, the clamp arms engage the leading edge of the sleeve to elastically deform inwardly and thereby close, and when the control line is pushed in the distal direction, the clamp arms are pushed distally out of the sleeve and automatically reopen due to their elastic restoring force. Since the clamp device can be repeatedly opened and closed, the clamp device can be arranged in a simple manner.

[0004] Once the clamping device is arranged in the correct position, the clamping arm must be locked in its closed state. For this purpose, an opening is provided at the clamping arm, into which a corresponding protrusion formed in the inner surface of the sleeve can engage. In order to lock the clamping arm in its closed state, the control wire is pulled in the proximal direction to such an extent that the protrusion engages with the opening formed in the clamping arm.

[0005] Furthermore, the clamping device with the clamping arm and the sleeve can be disconnected from the rest of the medical device. To do so, when the clamping device is fully closed, the control line is further pulled back, causing the J-hook to brake and thereby interrupt the connection between the clamping arm and the control line. Furthermore, by further pulling back the control line, a retainer connecting the control line to the sleeve is actuated so as to disconnect the retainer and thereby the control line from the sleeve. Summary of the invention

[0006] In view of this prior art, an object of the present disclosure is to provide a medical device of the above-mentioned type which is easy to handle as well as to manufacture and assemble and which operates in a reliable manner.

[0007] This object is solved by a medical device in which a pivot pin protrudes laterally on both sides from the distal ends of the clamp arm and the control line, and two locking protrusions are provided on the clamp housing, extending into the inner space of the clamp housing, wherein the locking protrusions are designed to allow the pivot pin to pass over them in the proximal direction and to prevent the pivot pin from passing in the distal direction so as to lock the clamp arm in a closed state.

[0008] A medical device for blood vessel hemostasis, comprising:

[0009] handle;

[0010] a sheath device attached to the handle;

[0011] a clamp device comprising a clamp housing defining a longitudinal direction, the clamp housing having a clamp base, in particular in the form of a sleeve, arranged on a distal end of the sheath device and at least two, in particular exactly two clamp arms, the clamp housing defining an inner space;

[0012] a control wire extending through the sheath device and reversibly movable in distal and proximal directions; and

[0013] an actuator coupled to the proximal end of the control wire and actuatable to reversibly move the control wire in distal and proximal directions;

[0014] wherein the clamp arms are each coupled to a distal end of a control wire, and wherein the clamp device is actuatable to open and close the clamp arms by movement of the control wires such that movement of the control wires in a proximal direction translates into a closing movement of the clamp arms, and movement of the control wires in a distal direction translates into an opening movement of the clamp arms;

[0015] wherein the clamp arm is coupled to and releasably retained at the distal end of the control line via a pivot pin extending through a corresponding through hole provided in a proximal end section of the clamp arm;

[0016] wherein a pivot pin projects laterally on both sides from the distal ends of the clamp arm and the control wire; and

[0017] Two locking protrusions are arranged on the clamp housing and extend into the inner space of the clamp housing, wherein the locking protrusions are designed to allow the pivot pin to pass over them in the proximal direction and prevent the pivot pin from passing in the distal direction so as to lock the clamp arm in a closed state.

[0018] The present disclosure is based on the consideration that a locking projection is provided which projects into the interior space of the clamp housing, whereby the pivot pin is locked proximally relative to the locking projection once the pivot pin has passed the locking projection. In this way, a stable and reliable locking of the clamp arm in its closed state can be achieved. Preferably, the pivot pin passes the locking projection in such a way that the end face of the pivot pin contacts the locking projection. Thus, the locking projections can be arranged on opposite sides of the interior space. Thus, the pivot pin can pass over the locking projection by means of elastic deformation and resume its original shape once it has passed the locking projection.

[0019] According to a preferred embodiment of the present disclosure, it can be provided that each locking protrusion has an inclined surface on its distal side relative to the longitudinal direction of the clamp housing, and a surface extending perpendicularly to the longitudinal direction on its proximal side. Preferably, the inclined surface is at an angle of inclination of at least 30° and / or at most 60°, preferably 45°, relative to the longitudinal direction of the clamp housing. Therefore, it is provided that the locking protrusion has an inclined surface on its distal side, so that the internal space tapers in this area so as to allow the pivot pin to pass through the locking protrusion by elastic and / or plastic deformation. Because the surface on the proximal side of the locking protrusion extends perpendicularly to the longitudinal direction, once the pivot pin has passed the locking protrusion, it is no longer possible to pass from the proximal direction to the distal direction. In this way, the pivot pin is securely locked to the locking protrusion on the proximal side, and the clamp arm is thereby maintained in its closed state.

[0020] In order to allow elastic and / or plastic deformation of the pivot pin when passing the locking projection, the pivot pin is preferably tubular in shape.The pivot pin may be made of a metallic material, in particular stainless steel, or a plastic material.

[0021] According to another embodiment, the clamp housing has two sliding grooves on its inner surface, which extend in the longitudinal direction and are arranged opposite each other so that the end section of the pivot pin engages in the sliding groove. In this way, it is ensured that the pivot pin cannot rotate relative to the clamp housing about the longitudinal direction of the clamp housing. In other words, a torsion-proof connection between the pivot pin and the clamp housing with respect to the longitudinal direction is achieved. The sliding groove can have a rectangular cross section.

[0022] The locking projection can protrude from the base of the corresponding sliding groove into the sliding groove. Therefore, the locking projection can be arranged completely in the sliding groove. In this way, interference of the locking projection with other components arranged or moved in the inner space of the clamp housing is avoided. According to a preferred embodiment, the locking projection extends over the entire width of the corresponding sliding groove.

[0023] The clamp arm may be provided as a discrete element that is pivotally coupled to the distal end of the control wire about a common pivot axis defined by a pivot pin.

[0024] Preferably, the clamp housing comprises two support arms which extend from the clamp base in the distal direction, wherein, in particular, the guide pin is held between the two support arms. Thus, each clamp arm can be provided with a guide slot, and the guide slots of the clamp arms partially overlap each other, and a guide pin attached to the clamp housing can extend through the guide slot in the overlapping portion of the guide slot, so that the movement of the control wire in the proximal direction is converted into a closing movement of the clamp arm and the movement of the control wire in the distal direction is converted into an opening movement of the clamp arm about the pivot axis by the engagement of the guide pin with the guide slot.

[0025] The clamp housing may comprise a central passage opening, in particular in the clamp base, which preferably has a rectangular cross section. Thus, the inner space of the clamp housing may be defined by the central passage opening and the space between the support arms.

[0026] Furthermore, a disengaging device may be provided, which allows the clamp arm to be disconnected from the control wire when the clamp arm is locked in the closed state and the control wire is pulled further in the proximal direction. In other words, it must be ensured that the clamp arm can be disconnected from the control wire when the clamp arm is in the closed state, whereby the clamping device should be released from the rest of the medical device.

[0027] Specifically, the control line can include a coupling head at its distal end, which includes at least one pair of retaining arms, which can be moved between a fixed position and a disengaged position, in which the retaining arms surround the pivot pin, thereby retaining the pivot pin in particular in a shape-fitting manner, and in the disengaged position, the retaining arms spread apart from each other, thereby releasing the pivot pin, wherein the retaining arms are biased toward their disengaged position, and the internal contour of the clamp housing cooperates with the retaining arms so that the retaining arms are pressed toward each other into their fixed position as long as the retaining arms extend to the distal section of the clamp housing, and so that when the control line is pulled in the proximal direction so that the retaining arms reach the proximal section of the clamp housing, the retaining arms automatically return to their disengaged position.

[0028] In other words, a specific coupling head is provided at the distal end of the control line. This coupling head comprises at least two retaining arms which engage around a pivot pin protruding laterally from the clamp arm as long as the clamp arm is coupled to the control line. The retaining arms of the coupling head of the control line are automatically held in their fixed position as long as the retaining arms extend to the distal section of the clamp housing. When the clamp arm is closed and in particular locked in its closed state and the control line is pulled back further, the retaining arms reach the proximal section, in particular a proximal section having an enlarged opening size compared to the distal section. Due to the elastic restoring force of the retaining arms, the retaining arms automatically return to their disengaged position when they reach the enlarged proximal section of the clamp housing, thereby releasing the pivot pin.

[0029] Specifically, the internal profile of the clamp housing can include a retaining groove, each pair of retaining arms is assigned a retaining groove, wherein the retaining groove receives the retaining arm between its side walls so that the retaining arm is against the side wall and is maintained in its fixed position as long as the retaining arm extends into the retaining groove, and each retaining groove proximally leads to an enlarged proximal section of the clamp housing, which has an enlarged opening size compared to the retaining groove so that when the control line is pulled in the proximal direction so that the retaining arm reaches the enlarged proximal section, the retaining arm automatically returns to their disengaged position. In other words, the retaining groove extending in the longitudinal direction of the clamp housing (which can in particular have a rectangular cross-section) is used to receive the retaining arm of the coupling head and to maintain it in its fixed position as long as the retaining arm is positioned in the retaining groove. Therefore, one of the pair of retaining arms is against one side wall of the retaining groove, while the other retaining arm is against the opposite side wall. In this way, the retaining wall is received in the retaining groove in a very space-saving manner.

[0030] According to another embodiment, the coupling head comprises exactly two pairs of retaining arms, which are arranged on two laterally opposite sides of the clamp arm, and a retaining groove is arranged in the clamp housing on both sides of the clamp arm. The coupling head can have a U-shaped or forked structure at its distal end.

[0031] Preferably, the sliding groove is arranged in the retaining groove, in particular in the base of the retaining groove. Thus, the retaining grooves arranged opposite to each other form a substantially rectangular cross-section, in particular a square cross-section, of the interior space of the clamp housing. In two laterally opposite faces of the interior space, a sliding groove can be arranged, which receives the end of the pivot pin.

[0032] The transition between the enlarged proximal section and the retaining slot can be formed as a step. Such a step is associated with an immediate change in the size of the opening between the enlarged proximal section and the retaining slot, so that there is a defined moment for uncoupling the pivot pin from the control line. Furthermore, once the retaining arm has reached its uncoupling position, it is not possible to bring the retaining arm back to its fixed position. In this way, incorrect use of the medical device can be excluded.

[0033] Preferably, the step is arranged relative to the locking projection so that the pivot pin passes through the locking projection before the retaining arms of the coupling head reach the enlarged proximal section and return to their disengaged position. This embodiment is based on the consideration that the clamp arms need to be locked in their closed state before they are separated from the control line. In this way, a safe and reliable operation can be guaranteed. Therefore, before the retaining arms extending to the distal position of the pivot pin can return to their disengaged position, the pivot pin needs to first pass through the locking projection. In particular, the step can be arranged distal to the locking projection.

[0034] A recess for receiving the pivot pin can be formed on the surfaces of the holding arms facing each other, wherein the recess preferably extends over the entire thickness of the respective holding arm and / or preferably has an at least substantially semicircular cross section. In this way, a form-fitting connection between the holding arm and the pivot pin can be achieved when the holding arm is in its fixed position. The semicircular cross section of the recess allows a pivoting movement of the pivot pin in the recess.

[0035] According to a preferred embodiment of the present disclosure, each pair of retaining arms is formed in a one-piece design so that the retaining arms can be elastically deformed between their fixed position and their disengaged position. In other words, the retaining arms of a pair of retaining arms are not formed as separate elements, but are formed as one component arranged at the distal end of the control line, wherein the retaining arms can be elastically deformed between their fixed position and their disengaged position. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The following will describe embodiments of the present disclosure with reference to the accompanying drawings. In this figure, it is shown:

[0037] Figure 1 is a front view of a medical device according to a first embodiment of the present disclosure;

[0038] Figure 2 yes Figure 1 an exploded view of a distal end of a medical device;

[0039] Figure 3 yes Figure 1 a perspective exploded view of a distal end of a medical device;

[0040] Figure 4 With open clamp arms Figure 1 A cross-sectional view of a distal end of a medical device;

[0041] Figure 5 is in another cross-sectional plane with the clamp arms opened Figure 1 A cross-sectional view of a distal end of a medical device;

[0042] Figure 6 With open clamp arms Figure 1 Another cross-sectional view of the distal end of the medical device;

[0043] Figure 7 With open clamp arms Figure 1 A cross-sectional view of a clamp base and a pivot pin of a medical device;

[0044] Figure 8 Has a closed clamp arm Figure 1 A cross-sectional view of a medical device;

[0045] Fig. 9 is a closed clamp arm in another cross-sectional plane Figure 1 A cross-sectional view of a distal end of a medical device;

[0046] Fig.10 is a cross-sectional view of a distal end of a medical device with closed clamp arms;

[0047] Fig.11 Has a closed clamp arm Figure 1 A cross-sectional view of a clamp base and a pivot pin of a medical device;

[0048] Fig.12 The clamp arm in another section plane is locked in its closed position Figure 1 A cross-sectional view of a distal end of a medical device;

[0049] Fig.13 is a cross-sectional view of the distal end of the medical device in another cross-sectional plane with the clamp arms locked in their closed state;

[0050] Fig.14 is a cross-sectional view of a distal end of a medical device with the clamp arms locked in their closed position;

[0051] Fig.15 The clamp arm is locked in its closed position Figure 1 A cross-sectional view of a clamp base and a pivot pin of a medical device;

[0052] Fig.16 is a partial perspective view of the distal end of the control wire and the clamp arm;

[0053] Fig.17 is a partial perspective view of a distal end of a medical device with a clamp device released from a sheath device;

[0054] Fig.18 is a front view of the clamp base;

[0055] Fig.19 is a longitudinal cross-sectional view of the clamp base;

[0056] Fig. 20 Another longitudinal cross-sectional view of the clamp base;

[0057] Fig.21 is a three-dimensional view of the clamp base;

[0058] Fig. 22 is a side view of a distal end of a control wire having a coupling head;

[0059] Fig.23 is a top view of the distal end of the control line;

[0060] Fig.24 yes Figure 1 A side view of a clamp arm of the instrument;

[0061] Fig.25 yes Figure 1 A partial cross-sectional view of the distal end of the medical device;

[0062] Fig.26 yes Figure 1 A partially exploded view of the distal end of the medical device of FIG. 1 , showing a release mechanism of the clamp base and the sheath device;

[0063] Fig. 27 is a partial cross-sectional view of a distal end of a medical device according to a second embodiment of the present disclosure, showing a sheath device, a connecting element, and a clamp base;

[0064] Fig.28 yes Fig. 27 A partial exploded view of a distal end of a medical device;

[0065] Fig.29 is a partial cross-sectional view of a distal end of a medical device according to a third embodiment of the present disclosure, showing a sheath device, a connecting element, and a clamp base;

[0066] Fig.30 yes Fig.29 A partial exploded view of a distal end of a medical device;

[0067] Fig.31 is a partial cross-sectional view of the distal end of a medical device according to a fourth embodiment of the present disclosure, showing a sheath device, a connecting element, and a clamp base; and

[0068] Fig.32 yes Fig.31 A partial exploded view of the distal end of a medical device.

[0069] List of reference numerals in the drawings:

[0070] 1 Handle

[0071] 2 Sheath device

[0072] 3 Clamping device

[0073] 4 Control lines

[0074] 5 Actuator

[0075] 6 Clamp housing

[0076] 7 Clamp base

[0077] 8a, 8b Clamp Arm

[0078] 9 Pivot pin

[0079] 10 Through holes

[0080] 11 Connector

[0081] 11a Sheet parts

[0082] 11b Squeeze tube

[0083] 12 Guide slots

[0084] 12a Curved section

[0085] 12b Straight section

[0086] 13 Guide pins

[0087] 14a, 14b support arm

[0088] 15 Center channel opening

[0089] 16 Slide slots

[0090] 17 Locking protrusion

[0091] 18 Inclined Surface

[0092] 19 Surface

[0093] 20a, 20b holding arm

[0094] 21 recess

[0095] 22 holding slots

[0096] 23 Enlarged proximal segment

[0097] 24 steps

[0098] 25 Sheath

[0099] 26 Connecting pipe

[0100] 27 Overlap Section

[0101] 28 through holes

[0102] 29 annular groove

[0103] 30 connection elements

[0104] 31 Main Segment

[0105] 32 center opening

[0106] 33 Connecting arm

[0107] 34Joint part

[0108] 35 Guide arm

[0109] 36 intermediate tube

[0110] 37a-d Barb

[0111] 38 grip sections

[0112] 39 V-shaped protrusion

[0113] 40V shaped recess

[0114] 41 rounded notch

[0115] 42Joint profile

[0116] 43 holding holes

[0117] 44 straight section

[0118] 45 inwardly protruding section

[0119] 46 protrusions

[0120] X longitudinal direction DETAILED DESCRIPTION

[0121] Figures 1 to 26 A first embodiment of a medical device according to the present disclosure is shown. The medical device is used to set a clamp for hemostasis of a blood vessel along the gastrointestinal tract, wherein the clamp is delivered to the target site through an endoscope.

[0122] The medical device comprises a handle 1, a sheath device 2 attached to the handle 1, and a clamp device 3 provided on the distal end of the sheath device 2. A control wire 4 extends through the sheath device 2 and is connected at its proximal end to an actuator 5, which is slidably held on the handle 1 and can be actuated to reversibly move the control wire 4 in the distal and proximal directions. The actuator 5 and the handle 1 are designed so that the control wire 4 can rotate relative to the sheath device 2 about its longitudinal axis.

[0123] The clamp device 3 comprises a clamp housing 6 having a clamp base 7 formed as a sleeve and two clamp arms 8a, 8b each coupled to the distal end of the control line 4. In particular, the two clamp arms 8a, 8b are separate elements / components which are coupled to the control line 4 by means of a tubular pivot pin 9. For this purpose, the pivot pin 9 extends through a corresponding through hole 10 provided in the proximal end section of the clamp arms 8a, 8b and is releasably held by a coupling head 11 formed at the distal end of the control line 4.

[0124] The two clamp arms 8a, 8b are connected to the distal ends of the control wire 4 so that they can rotate around a common pivot axis formed by a pivot pin 9 to open and close the clamp arms. Each clamp arm 8a, 8b is provided with a guide slot 12, and the guide slots 12 of the clamp arms 8a, 8b partially overlap each other. Each guide slot 12 includes a proximal curved section 12a and a distal straight section 12b. The clamp device 3 also includes a guide pin 13, which is attached to the clamp housing 6 and extends through the guide slot 12 in the overlapping section of the guide slot, so that the movement of the control wire 4 in the proximal direction is converted into a closing movement of the clamp arms 8a, 8b by the engagement of the guide pin 13 with the guide slot 12. The movement of the control wire 4 in the distal direction is converted into an opening movement of the clamp arms 8a, 8b around the pivot axis. In the present embodiment, the guide pin 13 is held between two support arms 14a, 14b of the clamp housing 6, which extend in the distal direction from the clamp base 7 to form a bifurcated structure, and between which the clamp arms 8a, 8b are arranged. The clamp housing 6 has an interior space, which is currently defined by a central passage opening 15 formed in the clamp base 7 and the space between the support arms 14a, 14b.

[0125] The caliper housing 6 has on its inner surface two sliding grooves 16 which extend in the longitudinal direction of the caliper housing 6 and are arranged opposite each other in such a way that the end sections of the pivot pin 9 engage in the sliding grooves 16. The sliding grooves 16 have a rectangular cross section.

[0126] like Figures 12 to 15 As shown, in order to lock the clamp arms 8a, 8b in the closed state, two locking projections 17 are provided on the clamp housing 6. At present, the locking projections 17 protrude from the base of the corresponding sliding groove 16 into the sliding groove 16 and extend over the entire width of the corresponding sliding groove 16. The locking projections 17 are designed so that they allow the pivot pin 9 to pass over them in the proximal direction, but prevent the pivot pin from passing in the distal direction so as to lock the clamp arms 8a, 8b in the closed state. For this purpose, each locking projection 17 has an inclined surface 18 at an inclined angle of 45° relative to the longitudinal direction X of the clamp base 7 on its distal side, and a surface 19 extending perpendicular to the longitudinal direction X on its proximal side.

[0127] The medical device further comprises a disengagement device which allows the clamp arms 8a, 8b to be disengaged from the control wire 4 when the clamp arms 8a, 8b are locked in the closed state and the control wire 4 is pulled further in the proximal direction.

[0128] For this purpose, the coupling head 11 has a forked holding structure, which includes two pairs of holding arms 20a, 20b, which are arranged on the transversely opposite sides of the clamp arms 8a, 8b. The holding arms 20a, 20b can be, for example, Figures 4 to 11 The fixed position shown is similar to e.g. Figures 12 to 15 The retaining arms 20a, 20b are movable between the disengaged positions shown. In the fixed position, the retaining arms 20a, 20b surround the pivot pin 9, thereby retaining the pivot pin 9 in a form-fitting manner. Specifically, recesses 21 with a semicircular cross section are formed in the surfaces of the retaining arms 20a, 20b facing each other. The pivot pin 9 is retained in these recesses 21 in the fixed position of the retaining arms 20a, 20b. In their disengaged position, the retaining arms 20a, 20b spread apart from each other, thereby releasing the pivot pin 9. The retaining arms 20a, 20b are biased toward their disengaged positions. As particularly Figure 2 and Figure 3 As can be seen in FIG. 1 , the coupling head 11 is formed by a sheet-like part 11 a forming two pairs of retaining arms and an extruded tube 11 b by means of which the sheet-like part 11 a is connected to adjacent side parts of the control line 4 .

[0129] The inner contour of the clamp housing 6 cooperates with the retaining arms 20a, 20b so that the retaining arms 20a, 20b are pressed toward each other into their fixed position as long as the retaining arms 20a, 20b extend to the distal section of the clamp housing 6. At present, the inner contour of the clamp housing 6 includes retaining grooves 22, one retaining groove 22 is assigned to each pair of retaining arms 20a, 20b and the retaining grooves 22 are open toward the distal end of the clamp housing 6. Therefore, a total of two retaining grooves 22 with a rectangular cross section are located on opposite sides of the inner space of the clamp housing 6. The retaining grooves 22 receive the retaining arms 20a, 20b between their side walls so that as long as the retaining arms 20a, 20b extend into the retaining grooves 22, the retaining arms 20b are pressed against the side walls and against their restoring forces into their fixed position.

[0130] The retaining groove 22 introduces an enlarged proximal section 23 of the clamp housing 6 proximally, which has an enlarged opening size compared to the retaining groove 22. The transition between the enlarged proximal section 23 with a substantially rectangular cross section and the retaining groove 22 is formed as a step 24. At present, the enlarged proximal section 23 extends over the central passage opening 15 and the proximal part of the support arms 14a, 14b. Therefore, when the control line 4 is pulled in the proximal direction so that the retaining arms 20a, 20b reach the enlarged proximal section 23, the retaining arms 20b automatically return to their disengaged position due to their restoring force.

[0131] At present, the step 24 is arranged relative to the locking projection 17 so that the pivot pin 9 passes through the locking projection 17 before the retaining arms 20a, 20b of the coupling head 11 reach the enlarged proximal section 23 and return to their disengaged position. Specifically, the step 24 is arranged on the distal side of the locking projection 17. Therefore, before the guide pin 13 reaches the distal end of the straight section 12b of the guide slot 12, the retaining arms 20a, 20b return to their disengaged positions.

[0132] The sheath device 2 comprises a coiled sheath 25 connected to the handle 1 and a connecting tube 26 which is fixedly connected, currently welded, to the distal end of the sheath 25 such that the sheath 25 and the connecting tube 26 form an inseparable unit.

[0133] The clamp housing 6 is directly and releasably connected to the connecting tube 26, so that the clamp housing 6 can be rotated about the longitudinal axis relative to the connecting tube 26. Specifically, this connection is achieved by a push-in connection, whereby an overlapping section 27 of the connecting tube 26 and the clamp housing 6 is formed. Figures 1 to 26 In the embodiment shown, the clamp housing 6 is pushed into the connecting tube 26 so that the clamp housing 6 forms the inner element and the connecting tube 26 forms the outer element. Two through holes 28 are formed in the overlapping section 27 of the clamp housing 6 and corresponding inwardly facing annular grooves 29 are formed in the overlapping section 27 of the connecting tube 26.

[0134] At present, a connecting element 30 is provided, which is engaged into the annular groove 29 through the through hole 28, so as to connect the clamp housing 6 to the sheath device 2 so that the clamp housing 6 can be rotated relative to the connecting tube 26 of the sheath device 2. Specifically, the connecting element 30 includes a proximal main section 31 in the form of a disc, which has a central opening 32. The control line 4 passes through the central opening 32. Two connecting arms 33 arranged opposite to each other in the circumferential direction extend distally from the main section 31, wherein an engaging portion 34 is formed at the distal end of the connecting arm 33 and extends radially outward through the through hole 28 into the annular groove 29. In addition, the connecting element includes two guide arms 35 extending distally from the main section 31. The guide arm 35 is arranged between the connecting arms 33 in the circumferential direction.

[0135] A release device is provided which cooperates with the connection element 30 and which can be actuated by moving the control line 4 in the proximal direction when the clamp arms 8a, 8b have been closed and the control line 4 has been disconnected from the clamp device 3, so as to disengage the connection element 30 from the annular groove 29 of the connection tube 26. Specifically, the release device comprises an intermediate tube 36 which surrounds the control line 4 and is arranged between the connection element 30 and the coupling head 11 of the control line 4.

[0136] The intermediate tube 36 is designed so that it can be pushed against the main section 31 of the connecting element 30. Therefore, when the control line 4 is moved in the proximal direction and the clamp arms 8a, 8b are already closed, the intermediate tube 36 can push the connecting element 30 in the proximal direction. In this way, the engagement portion 34 can be disengaged from the annular groove 29 formed in the connecting tube 26, thereby releasing the clamp housing 6 from the connecting tube 26, for example Fig.13 shown.

[0137] In use, the clamp device 3 is delivered to the target site through an endoscope and fixed to the blood vessel at a predetermined position on the target site. For this purpose, the clamp device 3 can be rotated relative to the sheath device 2 by rotating the control wire 4 relative to the sheath device 2. In order to clamp the blood vessel, the clamp arms 8a, 8b can be repeatedly opened and closed by moving the control wire 4 in the distal and proximal directions by means of the actuator 5.

[0138] In order to improve the grip of the tissue between the clamp arms 8a, 8b and to minimize the risk of the clamp device 3 coming loose when fixed to the tissue in the patient's body, each clamp arm 8a, 8b includes two barbs 37a, 37b, 37c, 37d, which are arranged in the gripping section 38 on the lateral opposite sides of the clamp arms 8a, 8b. The barbs 37a, 37b, 37c, 37d are formed so that each barb points in the direction of the corresponding opposite barb of the other clamp arm 8a, 8b. For example, in Fig.24 As can be seen in the figure, the clamp arm 8b comprises two barbs 37c, 37d pointing towards the other clamp arm 8a. The barb 37c comprises a clamping profile in the form of a V-shaped protrusion 39, wherein the barb 37d comprises a clamping profile in the form of a V-shaped recess 40 complementary to the V-shaped protrusion 39. The barb 37a of the clamp arm 8a has a V-shaped recess 40, while the barb 37b has a V-shaped protrusion 39, each complementary to the corresponding barb 37c, 37d of the other clamp arm 8b. In order to avoid accidental damage to the blood vessel clamped between the clamp arms 8a, 8b, the corners of the V-shaped protrusion 39 and the corners of the V-shaped recess 40 are rounded. In addition, rounded notches 41 are provided near the barbs 37a, 37b, 37c, 37d.

[0139] The distal end of the gripping section 38 of each clamp arm 8a, 8b is bent inwardly toward the other clamp arm 8a, 8b. An engagement profile 42 is formed at the distal end of each clamp arm 8a, 8b, in this case a sawtooth profile. The engagement profiles 42 of the clamp arms 8a, 8b complement each other so that they engage with each other when the clamp arms 8a, 8b are closed.

[0140] Once the clamping device 3 has been set, the clamping arms 8a, 8b are locked in their closed state. To this end, the control line 4 is pulled in the proximal direction so that the pivot pin 9 engaged in the sliding groove 16 passes the locking projection 17 and is thereby elastically deformed. When the pivot pin 9 has passed the locking projection 17, it cannot pass again in the distal direction because the surface 19 extends perpendicularly to the longitudinal direction X. In this way, the clamping arms 8a, 8b are prevented from being opened again unintentionally.

[0141] 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 retaining arms 20a, 20b reach the enlarged proximal section 23 of the clamp housing 6. Due to their elastic restoring force, they spread apart, thereby releasing the pivot pin 9 from the recess 21 formed in the retaining arms 20a, 20b.

[0142] In order to uncouple / release the clamp housing 6 from the sheath device 2, the control wire 4 is further pulled back in the proximal direction. As a result, the intermediate tube 36 is pressed between the coupling head 11 of the control wire 4 and the connecting element 30, thereby pushing the connecting element 30 in the proximal direction. In this way, the engaging portion 34 formed at the connecting arm 33 is disengaged from the annular groove 29 of the connecting tube 26 and the through hole 28 of the clamp housing 6, so that the clamp housing 6 is released from the connecting tube 26 of the sheath device 2.

[0143] Fig. 27 and 28 A second embodiment of a medical device according to the present disclosure is shown.

[0144] The medical device and Figures 1 to 26 2 and differs from this embodiment only in that the clamp housing 6 is not pushed into a connection tube 26 fixedly connected to the distal end of the sheath 25, but rather the clamp housing 6 forming an external element is pushed onto the connection tube 26, thereby forming an internal element. Thus, two through holes 28 arranged opposite to each other are formed in the connection tube 26, and an annular groove 29 facing inwards is formed in the clamp housing 6.

[0145] Therefore, in fact Figures 1 to 26 The connecting element 30 of the embodiment shown is formed similarly with its connecting arm 33 engaging portion 34 through the through hole 28 of the connecting tube 26 and engaging in the annular groove 29 of the clamp housing 6. In this way, the clamp housing 6 can be rotated relative to the sheath device by rotating the control wire 4.

[0146] Fig.29 and Fig.30 A third embodiment of a medical device according to the present disclosure is shown. Figures 1 to 26The medical device disclosed in is very similar, but the connecting element 30 is Figures 1 to 26 The connecting element 30 is currently formed as a planar disk with a central opening 32 and exactly two connecting arms 33 protruding radially outwards. Fig.29 As can be seen, the connecting arm 33 is arranged in one plane with the disk and engages through a through hole 28 formed in the clamp housing 6 into an annular groove 29 formed in the connecting pipe 26 .

[0147] In order to release the clamp housing 6 from the connecting tube 26 , the connecting element 30 is pushed in the proximal direction by the coupling head 11 of the control line 4 , thereby deforming the connecting element 30 and disengaging the connecting arms 33 from the annular groove 29 .

[0148] Fig.31 and 32 Another embodiment of a medical device according to the present disclosure is shown.

[0149] The medical device is almost the same as discussed previously. However, the sheath device 2 is connected to the clamp housing 6 by means of two connecting elements 30 in the form of elastic connecting arms, which are positioned on opposite sides of the clamp housing 6. Specifically, the distal end of the connecting element 30 is fixedly attached to the clamp housing 6, while the free proximal end of the connecting element 30 forms an engagement portion 34, which engages a corresponding engagement device provided in the inner peripheral surface of the connecting tube 26 so as to couple the clamp housing 6 to the sheath device 2. Here, the clamp housing 6 is connected to the sheath device 2 by a push-in connection, wherein the proximal end of the clamp housing 6 is inserted / extended into the distal end of the connecting tube 26. In the overlapping section of the connecting tube 26, through holes 28 arranged opposite to each other are formed in the clamp housing, and corresponding annular grooves 29 are formed in the connecting tube 26. The engaging portion 34 of the connecting element 30 is pressed outwardly through the through hole 28 of the clamp housing 6 into the annular groove 29 of the connecting pipe 26 , so as to connect the clamp housing 6 to the sheath device 2 .

[0150] The connecting element 30 has an inwardly protruding section. Furthermore, the distal end of the connecting element 30 points radially outwardly and extends into a corresponding retaining hole 43 provided in the clamp housing 6 and is preferably fixed therein by welding, currently by spot welding. The connecting element 30 also has a straight section 44 located behind the distal end of the connecting element 30, which is inclined inwardly relative to the central longitudinal axis of the clamp housing, wherein the inclination angle is 5°. Between the straight section 44 and the engaging portion 34 of the connecting element 30, an inwardly protruding section 45 is provided at the proximal end of the connecting element 30.

[0151] A release device is provided for disconnecting the clamp housing 6 from the connecting 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 cooperates with and is located between the inwardly protruding sections 45 of the connecting element 30 to press the inwardly protruding sections 45 outwardly to elastically deform the connecting element 30 so that their free ends are squeezed. When the control line 4 is pulled proximally and the protrusion 46 is disengaged from the connecting element 30, the protruding section 45 is deformed inwardly again by its elastic restoring force to obtain its original shape, and the engaging portion 34 is disengaged from the annular groove 29 formed in the connecting tube 26.

Claims

1. A medical device for vascular hemostasis, comprising: Handle (1); a sheath device (2), the sheath device (2) being attached to the handle (1); A clamp device (3), the clamp device (3) comprising a clamp housing (6) defining a longitudinal direction (X), the clamp housing (6) having a clamp base (7) arranged on the distal end of the sheath device (2) and at least two clamp arms (8a, 8b), the clamp housing (6) defining an internal space; a control line (4) extending through the sheath device (2) and capable of reversibly moving in distal and proximal directions; an actuator (5) coupled to the proximal end of the control wire (4) and actuatable to reversibly move the control wire (4) in a distal direction and a proximal direction; wherein the clamp arms (8a, 8b) are each coupled to a distal end of the control wire (4), and wherein the clamp device (3) is actuatable to open and close the clamp arms (8a, 8b) by movement of the control wire (4), such that movement of the control wire (4) in the proximal direction is converted into a closing movement of the clamp arms (8a, 8b), and movement of the control wire (4) in the distal direction is converted into an opening movement of the clamp arms (8a, 8b); wherein the clamp arms (8a, 8b) are coupled to and releasably retained at the distal end of the control line (4) via a pivot pin (9), the pivot pin (9) extending through a corresponding through hole (10) provided in a proximal end section of the clamp arms (8a, 8b), wherein the pivot pin projects laterally on both sides from the distal ends of the clamp arms (8a, 8b) and the control wire (4), and Two locking protrusions (17) are provided on the clamp housing (6), and the locking protrusions (17) extend into the internal space of the clamp housing (6), wherein the locking protrusions (17) are designed to allow the pivot pin (9) to pass over them in the proximal direction and prevent the pivot pin (9) from passing in the distal direction so as to lock the clamp arms (8a, 8b) in a closed state.

2. The medical device according to claim 1, characterized in that: The clamp base (7) is in the form of a sleeve.

3. The medical device according to claim 1, characterized in that: The at least two clamping arms (8a, 8b) are exactly two clamping arms (8a, 8b).

4. The medical device according to claim 1, characterized in that: Each locking projection (17) has an inclined surface (18) on its distal side relative to the longitudinal direction (X) of the clamp housing (6), and a surface (19) on its proximal side extending perpendicularly to the longitudinal direction (X).

5. The medical device according to claim 4, characterized in that: The inclined surface (18) is inclined at an angle of at least 30° and / or at most 60° relative to the longitudinal direction (X) of the clamp housing (6).

6. The medical device according to claim 5, characterized in that: The inclined surface (18) is inclined at an angle of 45° relative to the longitudinal direction (X) of the clamp housing (6).

7. The medical device according to any one of claims 1 to 6, characterized in that: The pivot pin (9) is tubular in shape.

8. The medical device according to any one of claims 1 to 6, characterized in that: The clamp housing (6) has two sliding grooves (16) on its inner surface (19), which extend along the longitudinal direction (X) and are arranged opposite to each other, so that each end section of the pivot pin (9) engages in one sliding groove (16).

9. The medical device according to claim 8, characterized in that: The locking projection (17) protrudes from the base of the corresponding sliding groove (16) into the sliding groove (16).

10. The medical device according to claim 8, characterized in that: The sliding groove (16) has a rectangular cross section.

11. The medical device according to claim 9, characterized in that: The locking projection (17) extends over the entire width of the corresponding sliding slot (16).

12. The medical device according to any one of claims 1 to 6, characterized in that: The clamp housing (6) comprises a central passage opening (15) and two support arms (14a, 14b) extending from the clamp base (7) in a distal direction, so that the internal space of the clamp housing (6) is defined by the central passage opening (15) and the space between the support arms (14a, 14b).

13. The medical device according to any one of claims 1 to 6, characterized in that: A disengagement device is provided, which allows the clamp arms (8a, 8b) to be disconnected from the control line (4) when the clamp arms (8a, 8b) are locked in the closed state and the control line (4) is pulled further in the proximal direction.

14. The medical device according to claim 13, characterized in that: The control line (4) comprises a coupling head (11) at its distal end, The coupling head (11) comprises at least one pair of retaining arms (20a, 20b), the retaining arms (20a, 20b) being movable between a fixed position, in which the retaining arms (20a, 20b) surround the pivot pin (9), and a disengaged position, in which the retaining arms (20a, 20b) spread apart from each other, thereby releasing the pivot pin (9). wherein the retaining arms (20a, 20b) are biased toward their disengaged positions, and The internal contour of the clamp housing (6) cooperates with the retaining arms (20a, 20b) so that the retaining arms (20a, 20b) are pressed toward each other into their fixed positions as long as the retaining arms (20a, 20b) extend into the distal section of the clamp housing (6), and when the control line is pulled in the proximal direction so that the retaining arms (20a, 20b) reach the proximal section of the clamp housing (6), the retaining arms (20a, 20b) automatically return to their disengaged positions.

15. The medical device according to claim 14, characterized in that: In the fixed position, the retaining arms (20a, 20b) retain the pivot pin (9) in a form-fitting manner.

16. The medical device according to claim 14, characterized in that: The inner contour of the clamp housing (6) comprises a retaining groove (22), one retaining groove (22) being assigned to each pair of retaining arms (20a, 20b), wherein the retaining groove (22) receives the retaining arms (20a, 20b) between their side walls so that the retaining arms (20a, 20b) abut against the side walls and are held in their fixed position as long as the retaining arms (20a, 20b) extend into the retaining groove (22), and Each retaining slot (22) proximally leads into an enlarged proximal section (23) of the clamp housing (6), and the enlarged proximal section (23) has an enlarged opening size compared to the retaining slot (22), so that when the control line (4) is pulled in the proximal direction and the retaining arm (20a, 29b) reaches the enlarged proximal section, the retaining arm (20a, 20b) automatically returns to its disengaged position, and the enlarged proximal section (23) has an enlarged opening size compared to the width of the retaining slot (22).

17. The medical device according to claim 16, characterized in that: The coupling head (11) comprises exactly two pairs of retaining arms (20a, 20b), which are arranged on two laterally opposite sides of the clamping arms (8a, 8b), and a retaining groove (22) is arranged on both sides of the clamping arms (8a, 8b).

18. The medical device according to claim 16, characterized in that: The transition between the enlarged proximal section (23) and the retaining groove (22) is formed as a step (24).

19. The medical device according to claim 18, characterized in that: The step (24) is arranged 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 enlarged proximal section (23) and return to their disengaged position.

20. The medical device according to claim 16, characterized in that The clamp housing (6) has two sliding grooves (16) on its inner surface (19), the two sliding grooves (16) extending along the longitudinal direction (X) and arranged opposite to each other, and the sliding grooves (16) are arranged in the retaining groove (22).

21. The medical device according to claim 20, characterized in that The sliding groove (16) is arranged in the base of the retaining groove (22).

22. The medical device according to claim 14, characterized in that A recess (21) for receiving the pivot pin (9) is formed in the surfaces (19) of the retaining arms (20a, 20b) facing each other.

23. The medical device according to claim 22, characterized in that The recess (21) extends over the entire thickness of the respective retaining arm (20a, 20b).

24. The medical device according to claim 22, characterized in that The recess (21) has a semicircular cross section.

25. The medical device according to claim 22, characterized in that The recess (21) extends over the entire thickness of the respective retaining arm (20a, 20b) and has a semicircular cross section.

26. The medical device according to claim 14, characterized in that Each pair of retaining arms is formed in a one-piece design, thereby enabling the retaining arms (20a, 20b) to be elastically deformable between their securing position and their disengaged position.

27. The medical device according to any one of claims 1 to 6, characterized in that: The clamp arms (8a, 8b) are provided as separate elements which are coupled to the distal end of the control wire (4) in a pivotable manner about a common pivot axis defined by the pivot pin (9).

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