Medical instrument for blood vessel hemostasis

Abstract

A medical device for hemostasis of a blood vessel by means of an endoscope, comprising: a handle (1); a sheath device (2) attached to the handle (1); a clamping device (3) comprising a clamping housing (6) arranged on the distal end of the sheath device (2) and at least two, in particular exactly two, clamping arms (8a, 8b); a control line (4) extending through the sheath device (2) and reversibly movable in a distal direction and a proximal direction; an actuator (5) coupled to a 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 line (4).

Description

Technical Field

[0001] The present disclosure relates to a medical device for hemostasis of blood vessels by means of an endoscope. Background Art

[0002] Such medical devices are known, for example, from EP 1328199 B1 and are used in particular for treating gastrointestinal bleeding. Specifically, such devices are used to set pliers or clips to clamp a bleeding blood vessel, thereby applying sufficient constricting force to the blood vessel to restrict or interrupt the blood flow therethrough.

[0003] The medical device known from EP 1328199 B1 includes a handle and a sheath attached to the handle. A control line extends through the sheath and can be actuated by an actuator coupled to the proximal end of the control line to move the control line reversibly in the distal and proximal directions. The medical device further includes a clamp device that includes a sleeve provided at the distal end of the sheath, and a clip having two clamp arms is coupled to the distal end of the control line by a J-shaped 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 set in a simple manner.

[0004] Once the clamp device is set in the correct position, the clamp arms must be locked in their closed state. For this purpose, openings are provided at the clamp arms, and corresponding protrusions formed in the inner surface of the sleeve can engage into the openings. To lock the clamp arms in their closed state, the control line is pulled in the proximal direction to such an extent that the protrusions engage the openings formed in the clamp arms.

[0005] In addition, the clamp device having the clamp arms and the sleeve can be disconnected from the rest of the medical device. To do so, when the clamp device is fully closed, the control line is further pulled back so that the J-shaped hook brakes and thereby interrupts the connection between the clamp arms and the control line. In addition, the holder connecting the control line to the sleeve is actuated by further pulling back the control line in order to disconnect the holder and thereby the control line from the sleeve. Summary of the Invention

[0006] In view of this prior art, it is an object of the present disclosure to provide a medical device of the above type that is easy to operate, easy to manufacture and assemble, and works in a reliable manner.

[0007] This object is solved by a medical device in which a housing is directly and releasably connected to a connecting tube such that the clamp housing can rotate relative to the connecting tube about a longitudinal axis.

[0008] A medical device for vascular hemostasis, comprising:

[0009] A handle;

[0010] A sheath device attached to the handle;

[0011] A clamp device including a clamp housing disposed at a distal end of the sheath device and at least two, in particular exactly two, clamp arms;

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

[0013] An actuator coupled to a proximal end of the control line and capable of actuating to reversibly move the control line in distal and proximal directions;

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

[0015] wherein the sheath device includes a sheath and a connecting tube, the sheath being preferably an extendable coiled sheath, the connecting tube defining a longitudinal axis and fixedly connected to a distal end of the sheath;

[0016] wherein the clamp housing is directly and releasably connected to the connecting tube such that the clamp housing can rotate relative to the connecting tube about the longitudinal axis.

[0017] The present disclosure is based on the consideration of providing the possibility of rotating the clamp device relative to the sheath about the longitudinal axis in order to increase the flexibility of the positions where the clamp arms can grip tissue in the human body. Thus, the arrangement of the clamp device inside the human body can be adapted to the orientation of the blood vessel to be clamped. The direct rotatable connection between the clamp housing and the connecting tube results in a compact design and a short structural length at the distal end of the medical device, since no intermediate element is required between the clamp housing and the connecting tube fixedly connected to the sheath.

[0018] Accordingly, it is provided that the clamp housing can rotate relative to the tube formed at the distal end of the sheath device, and the connecting tube is fixed to the distal end of the sheath in a torsion-resistant connection. On the other hand, the clamp arm can be connected to the clamp housing in a manner that cannot rotate relative to the longitudinal axis. In addition, the clamp housing can also be connected to the control line in a torsion-resistant manner, such that rotation of the control line relative to the sheath device will cause the clamp arm to rotate about the longitudinal axis, wherein the clamp housing rotates relative to the connecting tube of the sheath device. Therefore, the actuator and the handle are preferably designed such that the control line can rotate about its longitudinal axis relative to the sheath device.

[0019] According to a preferred embodiment of the present disclosure, the clamp housing and the connecting tube are connected to each other by a push-in connection, thereby forming an overlapping section of the connecting tube and the clamp housing, wherein the clamp housing as the internal element is pushed into the connecting tube as the external element, or the connecting tube as the internal element is pushed into the clamp housing as the external element, and at least two through holes are formed in the overlapping section of the internal element, which are offset at an angle in the circumferential direction, and an inward-facing annular groove is formed in the overlapping section of the external element, and at least one connecting element is provided, and the at least one connecting element passes through at least one through hole of the internal element and engages into the annular groove of the external element to connect the clamp housing to the sheath device, such that the clamp housing can rotate relative to the connecting tube of the sheath device.

[0020] Therefore, one of the two elements forming the external or female element (i.e., the clamp housing or the connecting tube) includes an inward-facing annular groove, while the other element forming the internal or male element includes through holes located in the same axial region as the annular groove. By means of the connecting element passing through the through hole and engaging into the annular groove, since the connecting element is fixed in the circumferential direction to the internal element by engaging into the through hole but can rotate freely relative to the external element by engaging into the annular groove, a rotatable connection between the two elements can be achieved. Such a connection saves space and allows a compact design of the distal end section of the medical device.

[0021] The internal element and the external element are preferably designed such that a clearance fit is achieved between the two elements. Therefore, the push-in connection can be easily released, and the internal element can rotate relative to the external element without applying significant force or kinetic energy.

[0022] A release device that cooperates with each connecting element can be provided, and the release device can be actuated by moving the control line in the proximal direction when the clamp arm has been closed and especially when the control line has been disengaged from the clamp device, so as to disengage the connecting element from the annular groove of the external element, thereby releasing the clamp housing from the sheath device. This design is based on the consideration that after the clamp has been disposed in the human body, the clamp housing must be separated from the sheath device so that the sheath device and the control line disposed in the sheath device can be retracted outside the human body through the working channel of the endoscope, and thus the clamp device should remain in the human body.

[0023] Specifically, the medical device may include exactly one connecting element having at least two, especially exactly two, connecting arms arranged at regular angular offsets in the circumferential direction, wherein each connecting arm passes through a corresponding through-hole formed in the internal element and engages into an annular groove formed in the external element. Preferably, the connecting arms of the connecting element are formed such that they engage into the annular groove formed in the external element with a clearance in the longitudinal and radial directions. In this way, the external element can be easily rotated relative to the internal element without requiring significant kinetic energy or force, wherein the clamp housing is releasably held at the connecting tube.

[0024] The connecting element can be formed as a disk having a central opening and at least two, especially exactly two, radially outwardly projecting connecting arms. Thus, the connecting element can be provided as a disk having a central opening and two radially projecting connecting arms that pass through corresponding through-holes formed in the internal element and engage into an annular groove formed in the external element, wherein the entire connecting element is formed as a flat disk.

[0025] Alternatively, the connecting element may include a proximal main section in the form of a disk and at least two, especially exactly two, connecting arms extending distally from the proximal main section, the disk having a central opening, wherein an engaging portion is formed at the distal end of the connecting arm and extends radially outward through the through-hole of the internal element and into the annular groove formed in the external element. In other words, the connecting element has a certain extension length in the longitudinal direction and includes a main section having a central opening through which the control line can pass and connecting arms extending distally from the main section. At the distal end of the connecting arm, the engaging portion extends radially outward, thereby protruding into the through-hole and the annular groove. By virtue of this offset in the longitudinal direction between the main section and the engaging portion, the connecting element is very elastic and can be disengaged from the annular groove of the external element by applying a small axial force on the main section in the proximal direction.

[0026] Additionally, a connection element of this type can include two or more guide arms extending distally from the main section. The guide arms are preferably arranged circumferentially between the connection arms in order to guide the connection element into the sheath device.

[0027] The release device can also include an intermediate tube that surrounds the control line and is arranged between the connection element and the connector formed at the distal end of the control line such that when the control line is moved in the proximal direction and the clamping arms are closed, the intermediate tube pushes the connection element in the proximal direction in order to disengage the connection element from the annular groove formed in the external element, thereby releasing the clamping housing from the connection tube. In other words, the intermediate tube can be arranged between the distal end of the control line, for example, the connector formed at the distal end of the control line. When the control line is pulled in the proximal direction and the clamping arms have been closed, the intermediate tube is clamped between the distal end of the control line and the connection element. Thus, further movement of the control line in the proximal direction will push the connection element proximally, thereby deforming the connection element such that the connection arms disengage from the annular groove. In particular, when the clamping housing is released from the sheath device, the distal ends of the connection arms can be straightened such that the engagement portion faces distally.

[0028] Alternatively, at least two, in particular exactly two, connection elements can be provided in the form of elastic, elastically deformable connection arms, wherein the distal ends of the connection elements are fixedly attached to the clamping housing and the free proximal ends of the connection elements form engagement portions, wherein each engagement portion engages through a corresponding through-hole formed in the internal element into an annular groove formed in the external element. Contrary to the embodiment discussed previously, the connection elements are fixedly connected to the clamping housing. Each through-hole formed in the internal element is assigned one connection element.

[0029] The release device may include a protrusion that is disposed between and cooperates with the connecting elements such that the protrusion presses against the connecting elements to elastically deform the connecting elements outwardly, so that the engaging portions of the connecting elements are forced outwardly to engage with the corresponding through holes and annular grooves, in order to connect the clamp housing to the sheath device. Wherein, the protrusion is coupled to the control line, particularly fixedly provided on the control line, such that if the control line moves further in the proximal direction after the clamp arms are closed, the protrusion moves together with the control line to disengage from the connecting elements. Thus, the connecting elements deform inwardly by their elastic restoring force, and the engaging portions of the connecting elements disengage from the corresponding annular grooves in the external elements to release the clamp housing from the sheath device. In other words, it may be provided that the connecting elements are biased towards an internal position where the connecting elements disengage from the corresponding annular grooves in the external elements. By means of a protrusion formed at the distal end of the control line, particularly a protrusion formed by a connector formed at the distal end of the control line, the connecting elements are pressed into an external position where the engaging portions engage into the annular grooves formed in the external elements, thereby holding the clamp housing at the distal end of the sheath device. When the control line is pulled in the proximal direction to such an extent that the protrusion disengages from the connecting elements, the connecting elements automatically deform inwardly due to their elastic restoring force, causing the engaging portions to move inwardly, thereby disengaging from the corresponding annular grooves. In this way, the clamp housing can be released from the sheath device in a very reliable manner.

[0030] The distal end of the connecting element may point radially outwardly and may extend into a corresponding holding hole provided in the clamp housing. Preferably, the distal end of the connecting element is fixed therein by welding, particularly by spot welding. The connecting element may have a straight section located behind the distal end of the connecting element, which is inclined inwardly relative to the longitudinal axis of the clamp housing, wherein the inclination angle is preferably about 5°. An inwardly protruding section may be provided at the proximal end of the connecting element.

[0031] The connecting tube and the sheath may be fusion welded, brazed or pressed together.

[0032] According to a further elaboration of the present disclosure, the clamp arms may be coupled to the distal end of the control line via a pivot pin that extends through a corresponding through hole provided in the proximal end section of the clamp arms and is held at the distal end of the control line.

[0033] The pivot pin can project laterally on both sides from the distal ends of the clamping arms and the control line, and can be guided in the clamping housing such that the pivot pin cannot rotate about the longitudinal axis of the clamping housing. Specifically, the clamping housing, which preferably defines an internal space, can have two sliding grooves on its inner surface, which extend in the longitudinal direction and are arranged opposite each other such that the end sections of the pivot pin engage in the sliding grooves. In this way, it is ensured that the pivot pin cannot rotate relative to the clamping housing about the longitudinal direction of the clamping housing. In other words, a torsion-resistant orientation between the pivot pin and the clamping housing relative to the longitudinal direction is achieved. The sliding grooves can have a rectangular cross-section.

[0034] Preferably, the clamping housing includes two support arms that extend from the clamping base in the distal end direction, particularly in the form of sleeves, wherein, in particular, the guide pin is held between the two support arms. Accordingly, each clamping arm can be provided with a guide groove, and the guide grooves of the clamping arms partially overlap each other, and the guide pin attached to the clamping housing can extend through the guide grooves in the overlapping part such that the movement of the control line in the proximal direction is converted into the closing movement of the clamping arms and the movement of the control line in the distal direction is converted into the opening movement of the clamping arms about the pivot axis by the engagement of the guide pin and the guide grooves.

[0035] The medical device can also be designed such that the control line includes a connector at its distal end, wherein the connector includes at least a pair of holding arms that can move between a fixed position and a disengaged engagement position. In the fixed position, the holding arms enclose the pivot pin and thus hold the pivot pin, in particular in a form-fitting manner. In the disengaged engagement position, the holding arms are spread apart from each other and thus release the pivot pin. The connector, particularly the holding arms of the connector, can be received by a holding groove formed in the clamping housing. Accordingly, the holding arms abut against the side walls of the holding groove. In this way, a non-rotatable relative connection between the control line and the clamping housing is achieved through the connector, preferably the pivot pin engaged in the sliding groove formed in the clamping housing, and the holding arms received in the holding groove. Therefore, the rotation of the control line relative to the sheath device caused by the actuator will result in the rotation of the clamping housing and thus the clamping arms relative thereto about the longitudinal axis of the connecting tube. Description of the Drawings

[0036] Embodiments of the present disclosure will be described hereinafter with reference to the accompanying drawings. Shown in these figures are:

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

[0038] Figure 2 is Figure 1 an exploded view of the distal end of the medical device;

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

[0040] Figure 4 Is a medical device with open jaw arms Figure 1 A cross-sectional view of the distal end of the medical device;

[0041] Figure 5 Is a cross-sectional view of the distal end of a medical device with open jaw arms in another cross-sectional plane Figure 1 Of the medical device;

[0042] Figure 6 Is another cross-sectional view of the distal end of a medical device with open jaw arms Figure 1 Of the medical device;

[0043] Figure 7 Is a cross-sectional view of the jaw base and pivot pin of a medical device with open jaw arms Figure 1 Of the medical device;

[0044] Figure 8 Is a cross-sectional view of a medical device with closed jaw arms Figure 1 Of the medical device;

[0045] Figure 9 Is a cross-sectional view of the distal end of a medical device with closed jaw arms in another cross-sectional plane Figure 1 Of the medical device;

[0046] Figure 10 Is a cross-sectional view of the distal end of a medical device with closed jaw arms

[0047] Figure 11 Is a cross-sectional view of the jaw base and pivot pin of a medical device with closed jaw arms Figure 1 Of the medical device;

[0048] Figure 12 Is a cross-sectional view of the distal end of a medical device with the jaw arms locked in their closed state in another cross-sectional plane Figure 1 Of the medical device;

[0049] Figure 13 Is a cross-sectional view of the distal end of a medical device with the jaw arms locked in their closed state in another cross-sectional plane

[0050] Figure 14 Is a cross-sectional view of the distal end of a medical device with the jaw arms locked in their closed state

[0051] Figure 15 Is a cross-sectional view of the jaw base and pivot pin of a medical device with the jaw arms locked in their closed state Figure 1 Of the medical device;

[0052] Figure 16 Is a partial perspective view of the distal end of the control line and the jaw arm;

[0053] Figure 17 Is a partial perspective view of the distal end of a medical device in which the jaw device is released from the sheath device;

[0054] Figure 18 Is a front view of the jaw base;

[0055] Figure 19 Is a longitudinal sectional view of the jaw base;

[0056] Figure 20 Another longitudinal sectional view of the jaw base;

[0057] Figure 21 Is a perspective view of the jaw base;

[0058] Figure 22 Is a side view of the distal end of the control line with a coupling head;

[0059] Figure 23 Is a top view of the distal end of the control line;

[0060] Figure 24 Is Figure 1 A side view of the jaw arm of the medical device;

[0061] Figure 25 Is Figure 1 A partial sectional view of the distal end of the medical device;

[0062] Figure 26 Is Figure 1 A partial exploded view of the distal end of the medical device, showing the release mechanism of the jaw base and the sheath device;

[0063] Figure 27 Is a partial sectional view of the distal end of a medical device according to a second embodiment of the present disclosure, showing the sheath device, the connecting element, and the jaw base;

[0064] Figure 28 Is Figure 27 A partial exploded view of the distal end of the medical device;

[0065] Figure 29 Is a partial sectional view of the distal end of a medical device according to a third embodiment of the present disclosure, showing the sheath device, the connecting element, and the jaw base;

[0066] Figure 30 Is Figure 29 A partial exploded view of the distal end of the medical device;

[0067] Figure 31is 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 connection element, and a clamp base; and

[0068] Figure 32 is Figure 31 a partial exploded view of the distal end of the medical device.

[0069] List of reference numerals in the drawings:

[0070] 1 Handle

[0071] 2 Sheath device

[0072] 3 Clamp device

[0073] 4 Control line

[0074] 5 Actuator

[0075] 6 Clamp housing

[0076] 7 Clamp base

[0077] 8a, 8b Clamp arms

[0078] 9 Pivot pin

[0079] 10 Through hole

[0080] 11 Connector

[0081] 11a Flake part

[0082] 11b Extrusion tube

[0083] 12 Guide groove

[0084] 12a Bending section

[0085] 12b Straight section

[0086] 13 Guide pin

[0087] 14a, 14b Support arms

[0088] 15 Central channel opening

[0089] 16 Slide groove

[0090] 17 Locking protrusion

[0091] 18 Tilted surface

[0092] 19 Surface

[0093] 20a, 20b Holding arms

[0094] 21 Recess

[0095] 22 Retaining groove

[0096] 23 Enlarged proximal section

[0097] 24 Step portion

[0098] 25 Sheath

[0099] 26 Connecting tube

[0100] 27 Lapping section

[0101] 28 Through hole

[0102] 29 Annular groove

[0103] 30 Connecting element

[0104] 31 Main section

[0105] 32 Central opening

[0106] 33 Connecting arm

[0107] 34 Joining part

[0108] 35 Guide arm

[0109] 36 Intermediate tube

[0110] 37a - d Barbs

[0111] 38 Gripping section

[0112] 39 V - shaped protrusion

[0113] 40 V - shaped recess

[0114] 41 Rounded notch

[0115] 42 Joining profile

[0116] 43 Retaining hole

[0117] 44 Straight section

[0118] 45 Inwardly protruding section

[0119] X Longitudinal direction Detailed implementation manner

[0120] Figures 1 to 26 A first implementation manner of a medical device according to the present disclosure is shown. The medical device is used to set a clamp for hemostasis of blood vessels along the gastrointestinal tract, wherein the clamp is delivered to the target site through an endoscope.

[0121] The medical device 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, which is slidably held on the handle 1 and can be actuated to reversibly move the control line 4 in the distal and proximal directions. 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.

[0122] The clamp device 3 includes a clamp housing 6, which has a clamp base 7 formed as a sleeve and two clamp arms 8a, 8b each connected to the distal end of the control line 4. Specifically, the two clamp arms 8a, 8b are discrete elements / components, which are 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 releasably held by a joint head 11 formed at the distal end of the control line 4.

[0123] The two clamp arms 8a, 8b are connected to the distal end of the control line 4 such that they can rotate about a common pivot axis formed by the pivot pin 9 in order to open and close the clamp arms. 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, which is attached to the clamp housing 6 and extends through the guide groove 12 in the overlapping section of the guide grooves, such that the movement of the control line 4 in the proximal direction is converted into the closing movement of the clamp arms 8a, 8b by the engagement of the guide pin 13 with the guide groove 12. The movement of the control line 4 in the distal direction is converted into the opening movement of the clamp arms 8a, 8b about 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 distally from the clamp base 7 to form a bifurcated structure, and the clamp arms 8a, 8b are arranged between these support arms 14a, 14b. The clamp housing 6 has an internal space, which is currently defined by a central channel opening 15 formed in the clamp base 7 and the space between the support arms 14a, 14b.

[0124] The clamp housing 6 has two sliding grooves 16 on its inner surface, which extend in the longitudinal direction of the clamp housing 6 and are arranged opposite to each other such that the end sections of the pivot pin 9 engage into the sliding grooves 16. The sliding grooves 16 have a rectangular cross-section.

[0125] As Figures 12 to 15As shown, in order to lock the clamp arms 8a, 8b in the closed state, two locking protrusions 17 are provided on the clamp housing 6. Currently, the locking protrusions 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 protrusions 17 are designed such that they allow the pivot pin 9 to pass through them in the proximal direction, but prevent the pivot pin from passing through in the distal direction, so as to lock the clamp arms 8a, 8b in the closed state. For this purpose, each locking protrusion 17 has an inclined surface 18 with an inclined angle of 45° relative to the longitudinal direction X of the clamp base 7 at its distal side, and a surface 19 extending perpendicular to the longitudinal direction X at its proximal side.

[0126] The medical device further includes a disengaging device that allows the clamp arms 8a, 8b to disengage from the control line 4 when the clamp arms 8a, 8b are locked in the closed state and the control line 4 is further pulled in the proximal direction.

[0127] For this purpose, the joint 11 has a bifurcated holding structure that includes two pairs of holding arms 20a, 20b, which are arranged on two opposite lateral sides of the clamp arms 8a, 8b. The holding arms 20a, 20b can move between a fixed position as shown, for example, Figures 4 to 11 and a disengaging position as shown, for example, Figures 12 to 15 In the fixed position, the holding arms 20a, 20b enclose the pivot pin 9, thereby holding the pivot pin 9 in a form-fitting manner. Specifically, recesses 21 with a semicircular cross-section are formed in the facing surfaces of the holding arms 20a, 20b. The pivot pin 9 is held in these recesses 21 in the fixed position of the holding arms 20a, 20b. In their disengaging position, the holding arms 20a, 20b are spread apart from each other, thereby releasing the pivot pin 9. The holding arms 20a, 20b are biased towards their disengaging position. As can be seen in particular in Figure 2 and Figure 3 the joint 11 is formed by a sheet-like part 11a and an extruded tube 11b. The sheet-like part 11a forms two pairs of holding arms, and the sheet-like part 11a is connected to the adjacent proximal part of the control line 4 by means of the extruded tube 11b.

[0128] The inner contour of the clamp housing 6 cooperates with the holding arms 20a, 20b such that as long as the holding arms 20a, 20b extend into the distal section of the clamp housing 6, the holding arms 20a, 20b are pressed towards each other into their fixed positions. Currently, the inner contour of the clamp housing 6 includes holding grooves 22, one holding groove 22 being assigned to each pair of holding arms 20a, 20b and the holding groove 22 opening towards the distal end of the clamp housing 6. Thus, a total of two holding grooves 22 with a rectangular cross-section are located on opposite sides of the inner space of the clamp housing 6. The holding grooves 22 receive the holding arms 20a, 20b between their side walls such that as long as the holding arms 20a, 20b extend into the holding grooves 22, the holding arms 20b are pressed against the side walls and are pressed into their fixed positions against their restoring force.

[0129] The holding groove 22 leads proximally into an enlarged proximal section 23 of the clamp housing 6 which has an enlarged opening dimension compared to the holding groove 22. The transition between the enlarged proximal section 23 with a substantially rectangular cross-section and the holding groove 22 is formed as a step 24. Currently, the enlarged proximal section 23 extends over the central channel opening 15 and the proximal parts of the support arms 14a, 14b. Thus, when the control line 4 is pulled in the proximal direction such that the holding arms 20a, 20b reach the enlarged proximal section 23, the holding arms 20b automatically return to their disengaged positions due to their restoring force.

[0130] Currently, 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 holding arms 20a, 20b of the joint head 11 reach the enlarged proximal section 23 and return to their disengaged positions. Specifically, the step 24 is arranged distally of the locking projection 17. Thus, the holding arms 20a, 20b return to their disengaged positions before the guide pin 13 reaches the distal end of the straight section 12b of the guide groove 12.

[0131] The sheath device 2 includes a coiled sheath 25 connected to the handle 1 and a connecting tube 26 which is fixedly connected to, currently welded to, the distal end of the sheath 25 such that the sheath 25 and the connecting tube 26 form an inseparable unit.

[0132] The clamp housing 6 is directly and releasably connected to the connecting tube 26 such that the clamp housing 6 can rotate relative to the connecting tube 26 about the longitudinal axis. Specifically, this connection is achieved by a push-in connection, thereby forming an overlapping section 27 of the connecting tube 26 and the clamp housing 6. In Figures 1 to 26In the illustrated embodiment, the clamp housing 6 is pushed into the connecting tube 26 such that the clamp housing 6 forms an inner element and the connecting tube 26 forms an outer element. Two through holes 28 are formed in the overlapping section 27 of the clamp housing 6, and corresponding inward-facing annular grooves 29 are formed in the overlapping section 27 of the connecting tube 26.

[0133] Currently, a connecting element 30 is provided which passes through the through hole 28 and engages into the annular groove 29 to connect the clamp housing 6 to the sheath device 2 such that the clamp housing 6 can rotate 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 this central opening 32. Two connecting arms 33 which are arranged opposite 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 and into the annular groove 29. In addition, the connecting element includes two guiding arms 35 which extend distally from the main section 31. The guiding arms 35 are arranged between the connecting arms 33 in the circumferential direction.

[0134] A release device which cooperates with the connecting element 30 is provided and 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 connecting element 30 from the annular groove 29 of the connecting tube 26. Specifically, the release device includes an intermediate tube 36 which surrounds the control line 4 and is arranged between the connecting element 30 and the joint 11 of the control line 4.

[0135] The intermediate tube 36 is designed such that it can be pushed against the main section 31 of the connecting element 30. Thus, when the control line 4 is moved in the proximal direction and the clamp arms 8a, 8b have been closed, the intermediate tube 36 can push the connecting element 30 in the proximal direction. In this way, the engaging 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 as Figure 13 shown.

[0136] In use, the clamp device 3 is delivered to the target site by means of an endoscope and the clamp device 3 is fixed to a 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 line 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 line 4 in the distal and proximal directions by means of the actuator 5.

[0137] To improve the grasping of tissue located between the clamp arms 8a, 8b and to minimize the risk of loosening the clamp device 3 when fixing to tissue within a patient, each clamp arm 8a, 8b includes two barbs 37a, 37b, 37c, 37d which are arranged in the grasping section 38 and are located on laterally opposite sides of the clamp arms 8a, 8b. The barbs 37a, 37b, 37c, 37d are formed such that each barb points in the direction of the corresponding opposite barb of the other clamp arm 8a, 8b. For example, as seen in Figure 24 it can be seen that the clamp arm 8b includes two barbs 37c, 37d which point towards the other clamp arm 8a. The barb 37c includes a clamping profile in the form of a V-shaped projection 39, where the barb 37d includes a clamping profile in the form of a V-shaped recess 40 which is complementary to the V-shaped projection 39. The barb 37a of the clamp arm 8a has a V-shaped recess 40, while the barb 37b has a V-shaped projection 39, each being complementary to the corresponding barbs 37c, 37d of the other clamp arm 8b. To avoid accidental damage to a blood vessel clamped between the clamp arms 8a, 8b, the corners of the V-shaped projection 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.

[0138] The distal ends of the grasping sections 38 of each clamp arm 8a, 8b are bent inwards towards the other clamp arms 8a, 8b. A mating profile 42 - in this case a serrated profile - is formed at the distal end of each clamp arm 8a, 8b. The mating profiles 42 of the clamp arms 8a, 8b are complementary to each other such that they mate with each other when the clamp arms 8a, 8b are closed.

[0139] Once the clamp device 3 has been set, the clamp arms 8a, 8b will be locked in their closed state. For this purpose, the control line 4 is pulled in the proximal direction such that the pivot pin 9 engaged in the sliding slot 16 passes through the locking projection 17 and is thereby elastically deformed. When the pivot pin 9 has passed through the locking projection 17, due to the surface 19 extending perpendicular to the longitudinal direction X, the pivot pin cannot pass through again in the distal direction. In this way, the clamp arms 8a, 8b are prevented from being inadvertently opened again.

[0140] As a next step, the clamp arms 8a, 8b are disconnected from the control line 4. For this purpose, the control line 4 is further pulled in the proximal direction such that the retaining arms 20a, 20b reach the enlarged proximal section 23 of the clamp housing 6. Due to their elastic restoring force, they expand, thereby releasing the pivot pin 9 from the recesses 21 formed in the retaining arms 20a, 20b.

[0141] To disconnect / release the clamp housing 6 from the sheath device 2, the control line 4 is further pulled back in the proximal direction. Accordingly, the intermediate tube 36 is pressed between the coupling head 11 of the control line 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 disengages 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.

[0142] Figure 27 and 28 shows a second embodiment of a medical device according to the present disclosure.

[0143] 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 housing 6 is not pushed into the connecting tube 26 fixedly connected to the distal end of the sheath 25. Instead, the clamp housing 6 forming the external element is pushed onto the connecting tube 26, thereby forming an internal element. Accordingly, two through holes 28 arranged opposite to each other are formed in the connecting tube 26, and an inward-facing annular groove 29 is formed in the clamp housing 6.

[0144] Accordingly, a connecting element 30, which is actually formed in the same way as the connecting element in the embodiment shown in Figures 1 to 26 , engages with the annular groove 29 of the clamp housing 6 through the through hole 28 of the connecting tube 26 with the engaging portion 34 of its connecting arm 33. In this way, the clamp housing 6 can be rotated relative to the sheath device by rotating the control line 4.

[0145] Figure 29 and Figure 30 shows a third embodiment of a medical device according to the present disclosure. This medical device is very similar to the medical device disclosed in Figures 1 to 26 but the connecting element 30 is different from the connecting element in the medical device of Figures 1 to 26 . Currently, the connecting element 30 is formed as a flat disk with a central opening 32 and exactly two radially outwardly protruding connecting arms 33. As can be seen in Figure 29 , the connecting arms 33 and the disk are arranged in a plane and engage with the annular groove 29 formed in the connecting tube 26 through the through holes 28 formed in the clamp housing 6.

[0146] To release the clamp housing 6 from the connecting tube 26, the connecting element 30 is pushed in the proximal direction through the coupling head 11 of the control line 4, thereby deforming the connecting element 30 and disengaging the connecting arm 33 from the annular groove 29.

[0147] Figure 31 and 32 shows another embodiment of a medical device according to the present disclosure.

[0148] This medical device is almost the same as the one 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, and these two connecting elements 30 are positioned on opposite sides of the clamp housing 6. Specifically, the distal ends of the connecting elements 30 are fixedly attached to the clamp housing 6, while the free proximal ends of the connecting elements 30 form engaging portions 34, and this engaging portion 34 engages corresponding engaging means 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 into / extends 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 outward through the through-hole 28 of the clamp housing 6 into the annular groove 29 of the connecting tube 26 so as to connect the clamp housing 6 to the sheath device 2.

[0149] The connecting element 30 has an inwardly protruding section. In addition, the distal ends of the connecting elements 30 point radially outward and extend into corresponding holding holes 43 provided in the clamp housing 6, and are preferably fixed therein by welding, currently by spot welding. The connecting element 30 also has a straight section 44 located after the distal end of the connecting element 30, and this straight section 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.

[0150] A release device for disconnecting the clamp housing 6 from the connecting tube 26 is provided. This release device includes a protrusion formed by a connector 11 provided at the distal end of the control line 4. The protrusion cooperates with the inwardly protruding section 45 of the connecting element 30 and is located between these inwardly protruding sections 45 to extrude the inwardly protruding section 45 outwardly to elastically deform the connecting element 30 so that their free ends are extruded. When the control line 4 is pulled proximally and the protrusion disengages from the connecting element 30, the protruding section 45 deforms inwardly again by its elastic restoring force to obtain its original shape, and the engaging portion 34 disengages from the annular groove 29 formed in the connecting tube 26.

Claims

1. A medical device for vascular hemostasis, comprising: a handle (1); a sheath device (2), the sheath device (2) being attached to the handle (1); a clamp device (3), the clamp device (3) including a clamp housing (6) provided at the distal end of the sheath device (2) and at least two clamp arms (8a, 8b); a control line (4), the control line (4) extending through the sheath device (2) and being capable of reversibly moving in the distal direction and the proximal direction; an actuator (5), the actuator (5) being coupled to the proximal end of the control line (4) and being capable of being actuated to cause the control line (4) to reversibly move in the distal direction and the proximal direction; wherein each of the clamp arms (8a, 8b) is coupled to the distal end of the control line (4), and wherein the clamp device (3) can be actuated to open and close the clamp arms (8a, 8b) through the movement of the control line (4), such that the movement of the control line (4) in the proximal direction is converted into the closing movement of the clamp arms (8a, 8b), while the movement of the control line (4) in the distal direction is converted into the opening movement of the clamp arms (8a, 8b); characterized in that the sheath device (2) includes a sheath (25) and a connecting tube (26), the connecting tube (26) defining a longitudinal axis and being fixedly connected to the distal end of the sheath (25); wherein the clamp housing (6) is directly and releasably connected to the connecting tube (26), such that the clamp housing (6) can rotate relative to the connecting tube (26) about the longitudinal axis.

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

3. The medical device according to claim 1, characterized in that, The sheath (25) is an extendable coiled sheath (25).

4. The medical device according to claim 1, characterized in that The clamp housing (6) and the connecting tube (26) are connected to each other by a push-in connection, thereby forming an overlapping section (27) of the connecting tube (26) and the clamp housing (6), wherein, the clamp housing (6) as an internal element is pushed into the connecting tube (26) as an external element, or the connecting tube (26) as an internal element is pushed into the clamp housing (6) as an external element, wherein at least two through holes (28) are formed in the overlapping section (27) of the internal element, the at least two through holes (28) being angularly offset in the circumferential direction, and an inward-facing annular groove (29) is formed in the overlapping section (27) of the external element, and at least one connecting element (30) is provided, the connecting element (30) passing through at least one through hole (28) of the internal element and engaging into the annular groove (29) of the external element so as to connect the clamp housing (6) to the sheath device (2), such that the clamp housing (6) can rotate relative to the connecting tube (26) of the sheath device (2).

5. The medical device according to claim 4, wherein A release device is provided that cooperates with each connection element (30), and when the clamp arms (8a, 8b) have been closed and the control line (4) has been disconnected from the clamp device (3), the release device can be actuated by moving the control line (4) in the proximal direction so as to disengage the connection element (30) from the annular groove (29) of the external element, thereby releasing the clamp housing (6) from the sheath device (2).

6. The medical device according to claim 5, characterized in that, The medical device includes exactly one connection element (30) having at least two connection arms (33) offset at regular angles in the circumferential direction, wherein each connection arm (33) engages through a corresponding through-hole (28) formed in the internal element into the annular groove (29) formed in the external element.

7. The medical device according to claim 6, wherein The connection element (30) is formed in a disk shape having a central opening (32) and at least two radially outwardly projecting connection arms (33).

8. The medical device according to claim 6, characterized in that, The connection element (30) includes a proximal main section (31) in the form of a disk having a central opening (32) and at least two connection arms (33) extending distally from the proximal main section (31), wherein a mating portion (34) is formed at the distal end of the connection arm (33) and extends radially outward through the through-hole (28) of the internal element and into the annular groove (29) formed in the external element.

9. The medical device according to any one of claims 5 - 8, characterized in that, The at least two connection arms (33) are exactly two connection arms (33).

10. The medical device according to claim 7 or 8, characterized in that, The release device includes an intermediate tube (36) that surrounds the control line (4) and is disposed between the connection element (30) and the joint (11) at the distal end formed on the control line (4), such that when the control line (4) is moved in the proximal direction and the clamp arms (8a, 8b) have been closed, the intermediate tube (36) pushes the connection element (30) in the proximal direction so as to disengage the connection element (30) from the annular groove (29) formed in the external element, thereby releasing the clamp housing (6) from the connection tube (26).

11. The medical device according to claim 5, characterized in that, At least two connection elements (30) are provided in the form of elastic, elastically deformable connection arms (33), wherein the distal ends of the connection elements (30) are fixedly attached to the clamp housing (6), and the free proximal ends of the connection elements (30) form mating portions (34), wherein each mating portion engages through a corresponding through-hole (28) formed in the internal element into the annular groove (29) formed in the external element.

12. The medical device according to claim 11, wherein, The at least two connection elements (30) are exactly two connection elements (30).

13. The medical device according to claim 11, wherein, The release device includes a protrusion which is arranged between the connecting elements (30) and cooperates with the connecting elements (30) such that the protrusion presses against the connecting elements (30), thereby elastically deforming the connecting elements (30) outwardly so that the engaging portion (34) of the connecting elements (30) is forced outwardly to engage with the corresponding through hole (28) and the annular groove (29) in order to connect the clamp housing (6) to the sheath device (2). Wherein, the protrusion is coupled to the control line (4) such that if the control line (4) moves further in the proximal direction after closing the clamp arms (8a, 8b), the protrusion moves together with the control line (4) to disengage from the connecting element (30). Thereby, the connecting element (30) deforms inwardly by its elastic restoring force and disengages the engaging portion (34) of the connecting element (30) from the corresponding annular groove (29) of the external element to release the clamp housing (6) from the sheath device (2).

14. The medical device according to claim 13, wherein, The protrusion is fixedly provided on the control line (4).

15. The medical device according to claim 13, wherein, The protrusion is formed by a joint head (11) formed at the distal end of the control line (4).

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

Images