Medical device and method for manufacturing the same

Abstract

The present invention relates to a medical device comprising a first part and a second part connected to each other by a connecting element so as to be pivotable relative to each other about a pivot axis defined by a longitudinal axis of the connecting element, the first part having at least one first bearing surface area and the second part having at least one second bearing surface area, the at least one first bearing surface area and the at least one second bearing surface area being arranged facing each other, and a biasing element is arranged between the at least one first bearing surface area and the at least one second bearing surface area in an attached state, the biasing element being held in a compressed state between the at least one first bearing surface area and the at least one second bearing surface area by the connecting element such that the biasing element exerts a biasing force on the at least one first bearing surface area and the at least one second bearing surface area in the attached state to maintain the at least one first bearing surface area and the at least one second bearing surface area biased away from each other.

Description

[Technical field]

[0001] The present invention relates to a medical device comprising a first part and a second part connected to each other by a connecting element so as to be pivotable relative to each other about a pivot axis defined by a longitudinal axis of the connecting element, in which the first part has at least one first bearing surface area and the second part has at least one second bearing surface area, the at least one first bearing surface area and the at least one second bearing surface area being arranged opposite each other.

[0002] Furthermore, the present invention relates to a method for manufacturing a medical device comprising a first part having at least one first bearing surface area and a second part having at least one second bearing surface area, comprising the steps of: arranging the at least one first bearing surface area and the at least one second bearing surface area opposite each other, and connecting the first part and the second part to each other by means of a connecting element such that the first part and the second part are pivotable relative to each other about a pivot axis defined by a longitudinal axis of the connecting element. [Background technology]

[0003] Medical instruments, also called surgical instruments, are known for their high precision. Different kinds of medical instruments are commonly used, such as pliers, nippers, clamps, needle holders or scissors. For such medical instruments, a joint defined by a connecting element connecting a first part and a second part of the medical instrument, free of play and with a smooth movement, is considered preferable by the surgeon. Handling such a medical instrument can give a reasonable impression of the quality of the medical instrument.

[0004] The medical device described at the outset is manufactured by connecting two parts with a connecting element, which is mainly used in the form of a screw, and which is adjusted by the connecting element. During the manufacture of the medical device, the operating forces at the joint of the medical device are adjusted by the pretensioning of the two parts, also called arms or branches, of the medical device relative to each other.

[0005] However, after several uses of the medical instrument by the user, wear occurs on the first and second bearing surface areas, also called the running surfaces, of the joint of the medical instrument. This effect increases unless oil is applied to the joint after reprocessing the medical instrument. Reprocessing in this sense means subjecting the medical instrument to cycles of cleaning and sterilization.

[0006] Such wear can cause play in the joints and a loss of operating force felt by the user during use.

[0007] SUMMARY OF THE PRESENT EMBODIMENT It is therefore an object of the present invention to provide an improved medical device, particularly one which has increased durability. Summary of the Invention

[0008] This object is achieved according to the invention in a medical device as mentioned at the beginning, in which in the attached state a biasing element is arranged between the at least one first and the at least one second bearing surface area, and which is held in a compressed state between the at least one first and the at least one second bearing surface area by the connecting element such that in the attached state the biasing element exerts a biasing force on the at least one first and the at least one second bearing surface area to keep the at least one first and the at least one second bearing surface area biased away from each other.

[0009] The provision of a biasing element on a medical instrument as proposed by the invention has the advantage, in particular, that there is no problem of loss of operating force. The biasing element arranged between the first and second bearing surface areas of the medical instrument, i.e. between the cooperating operating surfaces of the first and second parts of the medical instrument, is not subject to wear, as is the case with medical instruments without a biasing element. As already mentioned, wear has a negative effect on the quality of the medical instrument. Instead, the biasing element arranged between the first and second bearing surface areas generates a stable and permanent operating force over the entire range of motion of the medical instrument (also called the "opening angle" of the pivotally coupled first and second parts). A biasing element with a small suspension stroke improves the adjustability of the medical instrument, in particular the coupling action during assembly. Furthermore, the absence of play between the first and second parts of the medical instrument improves the accuracy of the entire medical instrument during the surgical operation, in particular the accuracy of the jaws or working end (working end) defined by the cooperating functional elements (working elements). In other words, the wear occurring during use of known standard medical instruments is compensated (suppressed) by the biasing element. If the improved medical instrument proposed according to the invention is adjusted during manufacture so that the biasing element exerts a biasing force on at least one first and at least one second bearing surface area (i.e. two parts of the medical instrument), said adjustment is maintained by the biasing properties of the biasing element in the mounted state (state in which the biasing element is held in compression between the first and second bearing surface areas).

[0010] Preferably, the biasing element is configured in the form of a spring washer having a central opening for receiving the connecting element, the biasing element being arranged to surround the pivot axis. Such an arrangement simplifies the assembly of the medical device. Using a connecting element in the form of a screw or rivet, the biasing element can be simply attached by passing the screw or rivet through the central opening of the spring washer. This ensures that the spring washer is held securely in place and will not fall off during use of the medical device. Furthermore, the spring washer is suitable for applying a biasing force to the first and second parts of the medical device.

[0011] Advantageously, the spring washer is configured in the form of a wave washer. A wave washer in this context is a spring washer having a wave-like shape, preferably with multiple inflection points or curves that define the varying curvature of the wave washer. In this way, the wave washer actually comprises multiple parts with a biasing effect. Thus, even if one wave of the wave washer is damaged and no longer functions as a biasing element, the remaining waves (i.e. biasing parts) of the wave washer can maintain the desired properties of the wave washer. Furthermore, the wave washer can be compressed into a substantially flat configuration while maintaining the desired biasing properties. This feature is not usually realized with Belleville washers.

[0012] According to a preferred embodiment, the wave washer has a wave-like shape defining at least one valley (wave trough) and at least one crest (wave crest), in particular in an initial state in which the wave washer is separated from the first and second bearing surface areas so as not to exert any spring force. In particular, the wave washer may have a number of valleys (wave troughs) and a number of crests (wave crests). As already mentioned, due to a number of such waves defined by a number of valleys (wave troughs) and a number of crests (wave crests), the biasing properties of the wave washer are improved compared to Belleville washers.

[0013] The spring washer can be manufactured in a simple manner if the wave washer has a constant or substantially constant thickness, which allows the wave washer to be manufactured from sheet material by squeeze molding.

[0014] Preferably, the wave washer is configured to wave along a circumferential direction based on the pivot axis. This means that a plurality of valleys (wave troughs) and a plurality of peaks (wave crests) extend radially (each along a radial direction). In other words, the wave washer has a wave-like structure visible from the side.

[0015] It is also advantageous if the wave washer is configured to undulate along a radial direction relative to the pivot axis, meaning that a number of waves are formed radially (each along a radial direction) with the wave maxima (peaks) and minima (valleys) extending in the circumferential direction.

[0016] Furthermore, it is preferred that the cutting line of the wave washer along the radial or circumferential direction with respect to the pivot axis has at least two inflection points, in particular three, four, five, six, seven or eight or more inflection points. As already mentioned, an inflection point in the mathematical sense means a point where the sign of the curvature changes. For example, a concave shape changes to a convex shape at an inflection point. In other words, the wave washer configured as described above has at least two changes of curvature along the circumferential or radial direction. The more inflection points are defined by the configuration of the spring washer, the more the so-called biasing portion of the spring washer having the above advantages is defined (formed).

[0017] According to a preferred embodiment, the wave washer has a first surface and a second surface facing in opposite directions, the first surface defining (forming) a first contact surface consisting of the crests (wave crests) and the second surface defining (forming) a second contact surface consisting of the valleys (wave troughs). Such a wave washer has the advantage that a plurality of contact points or lines are defined (formed) between the wave washer and the first and second support surfaces of the first and second parts of the medical device, respectively. This results in an approximately uniform distribution of the biasing force over the entire circumference of the wave washer.

[0018] The wave washer can be easily manufactured if the first and second contact surfaces run parallel or approximately parallel to one another. This property applies in particular in the initial state and / or in the mounted state. Such an arrangement allows a parallel adjustment of the first and second parts of the medical device in the connection area of ​​the medical device in the vicinity of the connecting element.

[0019] Furthermore, it is advantageous if the first and second contact surfaces are arranged at a first distance from each other in the initial state and at a second distance, greater than the first distance, from each other in the attached state, with the biasing element attached between the at least one first and the at least one second bearing surface area, so that, in particular in the attached state, the wave washer is in a compressed state so as to permanently exert a biasing force on the first and second bearing surface areas in order to maintain a desired operating force of the medical device.

[0020] Preferably, in the mounted state, the maximum value of the second distance is about 1.2 times the thickness of the wave washer, in particular about 1.1 times the thickness of the wave washer, in other words, if the ratio of the second distance to the thickness of the wave washer is within a defined range, in the mounted state the wave washer has a substantially flat configuration.

[0021] Furthermore, in the initial state, the first distance preferably has a value within a range of about two to about ten times the thickness of the wave washer. In particular, this value may be within a range of about two to about five times the thickness of the wave washer. This configuration defines the height and depth of the crests (wave crests) and valleys (wave troughs) in the initial state, and thus also defines the biasing characteristics of the wave washer. As a result, a wave washer optimal for each medical instrument can be selected to exert a desired operating force of the medical instrument.

[0022] According to one embodiment, the connection element is configured in the form of a pressing (non-retracting) connecting device with a single first bearing surface area and a single second bearing surface area, the first part with the single first bearing surface area being pressed against the single second bearing surface area with the biasing element being arranged between the single first bearing surface area and the single second bearing surface area. By providing such a connecting device, the medical device can be easily assembled when a first part of the medical device is provided, the biasing element is placed on the first bearing surface area and the second part of the medical device is placed so that the second bearing surface area is located on the biasing element. These three components (first part, biasing element, second part) can then be connected to each other using connecting elements such as screws, rivets, etc.

[0023] To obtain a medical device with increased stability in the region of the connecting element, it is advantageous if the connecting element is configured in the form of a box-type (contained) connecting device, the first part having a female connection part with an insertion opening and the second part having a male connection part which in the mounted state extends through said insertion opening. Such a box-type connecting device allows the second part of the medical device to be guided by the first part, since there are two cooperating support surfaces between the first and second parts, i.e. on both sides of the male connection part.

[0024] In particular, in the case of a box-shaped connecting device, it is advantageous if the female connecting part has two first bearing surface areas facing each other and the male connecting part has two second bearing surface areas facing away from each other, so that in such a medical device (i.e. a medical device having a connecting device in the form of a box-shaped connecting device) two separate bearing (load) surfaces can be defined.

[0025] To provide different types of medical instruments, it is preferred that the first part has a first distal end, the second part has a second distal end, a first tool element is formed or arranged on the first distal end, and a second tool element is formed or arranged on the second distal end, which cooperates with the first tool element, and the first and second tool elements form a medical tool. Thereby, depending on the respective types of the first and second tool elements, a desired medical tool can be formed. In particular, the tool elements may be configured in the form of clamp jaws, grip jaws or cutting blades, whereby a medical tool in the form of a clamp, a grip, a grasping forceps or a scissors (scissors) can be made.

[0026] Furthermore, according to another preferred embodiment, the first part may have a first proximal end, the second part may have a second proximal end, the first grip element may be formed or arranged on the first proximal end, and the second grip element may be formed or arranged on the second proximal end. The first grip element and the second grip element facilitate the handling of the medical instrument by the user. In particular, the first grip element and the second grip element may be configured in a ring shape. This allows the user to securely hold the medical instrument by passing at least one finger through each ring.

[0027] Preferably, the medical tool is configured in the form of scissors, a needle holder or a clamp. Thus, the improved properties of the proposed medical instrument comprising a biasing element arranged between the first and second bearing surface areas can be advantageous when used in connection with a number of different types of medical instruments.

[0028] If the connecting element is configured in the form of a screw or a rivet, the manufacture of the medical device is simplified and the adjustment of the medical device is also made easier. In particular, the screw may be used to fine-tune the desired operating force by more or less compressing the biasing element between a first bearing surface area of ​​the first part of the medical device and a second bearing surface area of ​​the second part of the medical device.

[0029] The object stated at the beginning is further achieved by the invention in a method for manufacturing a medical device as stated at the beginning, which method for manufacturing a medical device according to the invention further comprises the steps of arranging a biasing element between the at least one first and the at least one second bearing surface area before connecting the first and the second parts to each other, compressing the biasing element by the first and the second parts to a compressed state, and maintaining the compressed state by adjusting the connecting element such that the biasing element exerts a biasing force on the at least one first and the at least one second bearing surface area continuously in a direction such that the at least one first and the at least one second bearing surface area are biased away from each other.

[0030] The improved method for manufacturing a medical device proposed by the invention allows for easy adjustment of the medical device. The biasing element permanently exerts the desired biasing force on the two parts of the medical device by being compressed from an initial state to a compressed state during the manufacture, i.e. during assembly, of the medical device. Wear is compensated for (reduced) by the biasing element. Furthermore, the method for manufacturing a medical device proposed by the invention has the advantage that deformations of the two parts of the medical device (in particular the respective bearing surface areas) during manufacture or manufacturing tolerances can be easily compensated for (reduced) by the biasing element. Thus, the method for manufacturing a medical device proposed by the invention can in particular be performed fully automatically (i.e. by machine). In other words, the method for manufacturing a medical device proposed by the invention allows the production of the medical device by machine. Manual adjustments are usually not required.

[0031] It is further proposed to use a wave washer as a biasing element in the manufacturing method described above or in the medical device of any of the embodiments described above. [Brief description of the drawings]

[0032] In order to facilitate a more detailed explanation of the present invention, preferred embodiments will now be described in conjunction with the following drawings.

[0033] [Figure 1] 1 shows a schematic exploded view of a medical device according to one embodiment. [Diagram 2] 2 shows an enlarged partial view of the distal end of the medical device shown in FIG. 1. [Diagram 3] 3 is a partially cutaway view of the portion shown in FIG. 2 before adjustment of the connecting element, i.e., with the biasing element in its initial state; FIG. [Figure 4] FIG. 4 shows, in a partially cutaway view, the part shown in FIG. 3 in an attached state, i.e. with the biasing element in compression; [Diagram 5] 5 shows a plan view, partly in section, of the part shown in FIG. 4 in the region of the connection device; FIG. [Figure 6] 6 is a cross-sectional view taken along line 6-6 in FIG. 5, showing the medical device in a state before adjustment. [Figure 7] 7 is a view similar to FIG. 6 showing the biasing element in an attached and compressed state. [Figure 8] FIG. 8 shows a perspective view of a biasing element according to the embodiment shown in FIGS. 1 to 7. [Figure 9] FIG. 9 shows a side view of the biasing element of FIG. 8. [Figure 10] FIG. 10 shows a plan view of the biasing element shown in FIGS. 8 and 9. [Figure 11] FIG. 13 shows a perspective view of a wave washer according to another embodiment. [Figure 12] FIG. 12 shows a side view of the wave washer shown in FIG. [Figure 13] FIG. 13 shows a plan view of the wave washer shown in FIGS. 11 and 12. [Figure 14]13 shows a perspective view of a wave washer according to yet another embodiment. [Figure 15] FIG. 15 shows a side view of the wave washer shown in FIG. [Figure 16] FIG. 16 shows a plan view of the wave washer shown in FIGS. 14 and 15. [Figure 17] 13 shows a perspective view of a wave washer according to yet another embodiment. [Figure 18] FIG. 18 shows a side view of the wave washer shown in FIG. [Figure 19] FIG. 19 shows a plan view of the wave washer shown in FIGS. 17 and 18. [Figure 20] 13 shows a perspective view of a wave washer according to yet another embodiment. [Figure 21] FIG. 21 shows a side view of the wave washer shown in FIG. [Figure 22] FIG. 22 shows a plan view of the wave washer shown in FIGS. 20 and 21. [Figure 23] FIG. 13 shows a partially cutaway view of another embodiment of a medical device with a box-shaped connecting device in an installed state. [Figure 24] 24 shows a cross-sectional view taken along line 24-24 in FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] Fig. 1 shows an exploded view of a medical device 10 according to a first embodiment. The medical device 10 comprises a first part 12 and a second part 14. The exploded view of Fig. 1 shows the medical device 10 in the middle of being assembled.

[0035] The first part 12 has a first distal end 16 and a first proximal end 18. A first tool element 20 is formed or disposed on the first distal end 16. Additionally, the first proximal end 18 has a first grip element 22 formed or disposed on it.

[0036] Similar to the configuration previously described with respect to the first part 12, the second part 14 has a second distal end 24 and a second proximal end 26. A second tool element 28 is formed or disposed on the second distal end 24, configured to cooperate with the first tool element 20. Additionally, a second grip element 30 is formed or disposed on the second proximal end 26.

[0037] The first tool element 20 and the second tool element 28 form or define a medical tool 32 .

[0038] 1 to 7, the first tool element 20 and the second tool element 28 are configured in the form of clamp jaws 34, 36. As a result, the medical instrument 10 is configured as a whole in the form of a medical clamp 38.

[0039] The first and second gripping elements 22, 30 are configured in the form of rings 40, 42 commonly used on standard medical instruments of this type for easy holding by a surgeon or other user.

[0040] In an alternative embodiment not shown, the first tool element 20 and the second tool element 28 may be made in the form of cooperating cutting blades, in which case the medical tool 32 is configured in the form of scissors.

[0041] In yet another embodiment not shown, the medical tool 32 may be configured in the form of a needle holder having multiple gripping stages structurally.

[0042] The first and second parts 12, 14 are connected to one another at a connection region 44 by a connecting element 46. The embodiment of the medical device 10 shown in Figure 1 has arms 48, 50 (also referred to as "branches") extending between the connection region 44 and the respective proximal ends 18, 26.

[0043] Furthermore, the first component 12 has a first support surface area (first bearing surface area) 52. The second component 14 has a second support surface area (second bearing surface area) 54. As shown in Figures 1 to 7, the first support surface area 52 and the second support surface area 54 are arranged to face each other.

[0044] In the case of a standard medical device, the first part 12 and the second part 14 would be assembled such that the first and second bearing surface areas 52, 54 are in direct contact with each other and are connected by connecting elements in the form of screws or rivets for pivotably connecting the first part 12 and the second part 14 to each other.

[0045] 1-7, the first and second bearing surface areas 52, 54 do not directly contact each other. Rather, a biasing element 56 is disposed between the first and second bearing surface areas 52, 54.

[0046] The connection region 44 comprises in particular a first bearing surface region 52, a second bearing surface region 54 and a connecting element 46 which together define (form) a so-called connecting device 58. The connecting element 46 serves the purpose of pivotably connecting the first part 12 and the second part 14 to one another such that they are pivotable about a pivot axis 60 defined by a longitudinal axis 62 of the connecting element 46.

[0047] The biasing element 56 is configured in the form of a spring washer 64 having a central opening 66 for receiving the connecting element 46. The configuration of the spring washer 64 allows the biasing element 56 to be positioned around the pivot 60, as shown particularly in Figures 5 and 6.

[0048] Figures 1 to 10 show an embodiment of a spring washer 64 in the form of a so-called wave washer 68. The wave washer 68 has a wave-like shape, as shown in particular in Figures 8 to 10. Figures 8 to 10 show the initial state of the wave washer 68, which is separated from the first part 12 and the second part 14. In this initial state, the wave washer 68 does not exert any spring force.

[0049] The wavy shape of the wave washer 68 defines (forms) a plurality of valleys (wave troughs) 70 and a plurality of peaks (wave crests) 72.

[0050] Additionally, the wave washer 68 in the embodiment illustrated in FIGS. 1-10 has a constant or approximately constant thickness 74.

[0051] 1 to 10 is configured to wave in the circumferential direction based on the pivot shaft 60. This means that the curvature of the wave washer 68 alternates between a convex curvature to a concave curvature and a concave curvature to a convex curvature.

[0052] The wave washer 68 has a first surface 76 and a second surface 78. The first surface 76 and the second surface 78 face in opposite directions. As shown in FIG. 9 , the first surface 76 defines (forms) a first contact surface 80 at the peak 72. The second surface 78 defines (forms) a second contact surface 82 at the valley 70.

[0053] The first contact surface 80 and the second contact surface 82 extend parallel or approximately parallel to each other, which is the case in the initial state shown in Figure 9, but also in the attached state described below.

[0054] The cut line 84 of the wave washer 68 along the circumferential direction defines a number of inflection points 86, 88 that are alternately formed along the circumference of the cut line 84. With reference to Figures 8-10 with respect to the first surface 76, adjacent inflection points 86, 88 define either a peak portion 72 or a valley portion 70 between these inflection points 86, 88.

[0055] As shown in FIG. 10, when moving from any inflection point 86 in a clockwise direction 90 along the circumferential direction along which the cutting line 84 extends, the wave washer 68 follows the concave curvature of the wave washer 68 that faces away from the first surface 76 until it reaches an adjacent inflection point 88, at which point the curvature changes from a concave curvature relative to the first surface 76 to a convex curvature. When moving further in a clockwise direction 90 along the cutting line 84 toward the next inflection point 86, the curvature remains substantially convex until it reaches the inflection point 86. Such a change in curvature along the cutting line 84 continues around the entire circumference. The above configuration is caused by the wave washer 68 having a shape that undulates along the circumferential direction relative to the pivot axis 60.

[0056] As already mentioned, Fig. 1 shows a schematic representation of the assembly of the medical device 10. The second part 14 comprises a through hole 92 having an enlarged region 94. The enlarged region 94 is adapted to receive a head 100 of a connecting screw 98. The through hole 92 is adapted to receive a shank 96 of a connecting element 46 in the form of a connecting screw 98.

[0057] The connecting screw 98 has a threaded shank 102 extending between the body 96 and a free end 104 opposite the head 100 .

[0058] The first part 12 is provided with a through hole 106 having an internal thread 108 for receiving the threaded portion 102 of the connecting screw 98 .

[0059] To assemble the medical device 10, the connecting screw 98 is introduced into the through hole 92 at the free end 104 such that the threaded portion 102 protrudes beyond the second bearing surface area 54, as shown in FIG.

[0060] The wave washer 68 is then placed over the threaded portion 102 such that the second surface 78 contacts the second bearing surface area 54 as shown in FIG.

[0061] The first part 12 is then engaged with the connecting threads 98 by threading the threaded portion 102 into a through hole 106 having a corresponding internal thread 108 .

[0062] 6 shows a state during assembly, in which the wave washer 68 is still in its initial state. That is, the wave washer 68 has not deformed from the initial state shown in Figures 8 to 10 and does not exert any spring force. However, the first surface 76 contacts the first support surface area 52 at its peak portion 72.

[0063] In the initial state, the first contact surface 80 and the second contact surface 82 define a first distance 110 from each other. As long as the wave washer 68 is in the initial state, the first distance 110 corresponds to the gap between the first bearing surface area 52 and the second bearing surface area 54, as shown in FIG.

[0064] To adjust the medical device 10, the connecting screw 98 is further screwed into the through hole 106, which causes the wave washer 68 to be compressed and transition from the initial state to a compressed state. Fig. 7 shows the compressed state of the wave washer 68 in the attached state (assembled state) of the medical device 10.

[0065] In this mounted condition, the first and second contact surfaces 80, 82 define a second distance 112 from one another. The second distance 112 corresponds to the reduced gap between the first and second bearing surface areas 52, 54. As can be seen in Figures 6 and 7, the first distance 110 is greater than the second distance 112.

[0066] Furthermore, the wave washer 68, i.e. the biasing element 56, is disposed between the first and second bearing surface areas 52, 54 in the attached state and is held in compression by the connecting element 46. The biasing element 56 is held in compression by the configuration of the connecting device 58, thereby exerting a biasing force on the first and second bearing surface areas 52, 54 to maintain a bias in a direction away from each other.

[0067] The spring force that the wave washer 68 exerts on the first and second parts 12, 14 depends on the compression of the wave washer 68. The more the wave washer 68 is compressed, the greater the spring force. This allows for individual adjustment of the operating force of the medical device 10 when the first and second parts 12, 14 are pivoted relative to each other about the pivot axis 60. The operating force is related to the friction between the first and second parts 12, 14 and the biasing element 56.

[0068] In order to improve the washability of the medical instrument 10, it is preferable that the maximum value of the second distance 112 is adjusted to be about 1.2 times the thickness 74 of the wave washer 68 in the attached state. In order to reduce the gap between the first support surface area 52 and the second support surface area 54 defined by the valley portion 70 and the peak portion 72, the connection screw 98 is adjusted so that the maximum value of the second distance 112 is about 1.1 times the thickness 74 of the wave washer 68.

[0069] 9, the first distance 110 in the initial state has a value within a range of about 2 to about 10 times the thickness 74 of the wave washer 68. In the embodiment shown in FIG. 9, the ratio of the first distance 110 to the thickness 74 is about 5:1. This means that the first distance 110 has a value within a range of about 2 to about 5 times the thickness 74 of the wave washer 68.

[0070] The medical device 10 shown in Figures 1 to 7 includes a connection device 58 configured in the form of a press-type (non-retractable) connection device 114. The press-type connection device 114 includes a single first support surface area 52 and a single second support surface area 54. Furthermore, the press-type connection device 114 is configured such that the first part 12 having the single first support surface area 52 is pressed against the single second support surface area 54 with a biasing element 56 disposed between the first support surface area 52 and the second support surface area 54.

[0071] As described above, the wave washer 68 of the embodiment shown in Figures 1 to 10 has five valleys 70 and five peaks 72, and five inflection points 86 and five inflection points 88 corresponding to these, along the cutting line 84.

[0072] Figures 11 to 13 show a wave washer 68 according to another embodiment. The configuration of the wave washer 68 shown in Figures 11 to 13 is similar to the wave washer 68 shown in Figures 1 to 10. Therefore, the same reference numerals are used to indicate the same or similar elements.

[0073] The main difference between the wave washer 68 shown in Figures 11-13 and the wave washer 68 shown in Figures 1-10 is the number of valleys (wave troughs) 70 and peaks (wave crests) 72. In the embodiment shown in Figures 11-13, the wave washer 68 has only three valleys 70 and three peaks 72. This results in a corresponding number of inflection points 86, 88 along the cutting line 84, i.e., three inflection points 86 and three inflection points 88.

[0074] Figures 14 to 16 show a wave washer 68 according to yet another embodiment. In Figures 14 to 16, the same reference numerals as in the embodiment shown in Figures 1 to 13 are used to indicate the same or similar elements.

[0075] The wave washer 68 according to the embodiment shown in Figures 14 to 16 also has a different number of valleys 70 and peaks 72 compared to the previously described embodiments. In the embodiment shown in Figures 14 to 16, the wave washer 68 has ten valleys 70 and ten peaks 72. This results in a corresponding number of ten inflection points 86 and ten inflection points 88 along the cutting line 84 mentioned above.

[0076] 17 to 19 show a spring washer (wave washer 68) according to another embodiment. The configuration of the spring washer (wave washer 68) in FIGS. 17 to 19 differs from the previously described spring washer in that the spring washer (wave washer 68) is configured to wave along a radial direction based on the pivot axis 60. As a result, a cutting line 84 along a radial direction 116 based on the pivot axis 60 has two inflection points 86, 88. A valley portion (wave valley) 70 is defined from the pivot axis 60 to the inner edge of the wave washer 68 surrounding the central opening 66. The concave curvature of the valley portion 70 changes to a convex curvature at the inflection point 88. Moving further away from the pivot axis 60, one comes to a crest portion (wave crest) 72, and moving further from the crest portion 72 towards the outer edge of the wave washer 68 which defines the second valley portion (second wave trough) 70, one passes through a second inflection point 86, at which point the convex curvature changes to a concave curvature.

[0077] 20 to 22 show a wave washer 68 according to still another embodiment. In Figs. 20 to 22, the same reference numerals as in Figs. 17 to 19 are used to indicate the same or similar elements.

[0078] The embodiment of Figures 20-22 generally corresponds to the embodiment shown in Figures 17-19. This means that the wave washer 68 is configured to undulate along a radial direction 116 relative to the pivot axis 60. In the embodiment of Figures 20-22, the wave washer 68 comprises three valleys (wave troughs) 70 and two peaks (wave crests) 72, starting with the valley (wave trough) 70 defined by the inner edge that defines the central opening 66. The outer edge of the wave washer 68 defines a further valley (wave trough) 70.

[0079] Figures 23 and 24 show another embodiment of the medical instrument 10, specifically the distal end region of the medical instrument 10. The medical instrument 10 of Figures 23 and 24 is configured in the form of a needle holder 118. The tool elements 20, 28 are curved along a reference plane that extends perpendicular to the pivot axis 60.

[0080] The medical device 10 shown in Figures 23 and 24 differs from the medical device 10 shown in Figures 1 to 7, particularly in the configuration of a connection device 58. The medical device 10 shown in Figures 23 and 24 includes a connection device 58 configured in the form of a box-type (storage type) connection device 120.

[0081] The box-shaped connection device 120 is characterized in that the first component 12 is provided with a female connection portion 122 having an insertion opening 124. The second component 14 has a male connection portion 126 that extends through the insertion opening 124 in the attached state, as shown in Figures 23 and 24. With this configuration, the female connection portion 122 has two first support surface regions 52 that face each other. The male connection portion 126 has two second support surface regions 54 that face in directions away from each other. However, each first support surface region 52 faces a corresponding second support surface region 54.

[0082] A biasing element 56 is disposed between each first bearing surface area 52 and the corresponding second bearing surface area 54. Figure 24 shows the two biasing elements 56 in a compressed state, i.e. in the attached (assembled) state of the medical device 10.

[0083] The second part 14 is provided with a through hole 106 coaxial with the pivot shaft 60. The through hole 106 is provided with an internal thread 108.

[0084] For connecting the first part 12 and the second part 14 to one another, two connecting elements 46 in the form of connecting screws 98 are provided. In an alternative embodiment, a rivet for connecting the first part 12 and the second part 14 to one another may also be provided so as to form a so-called riveted box lock with the biasing element 56.

[0085] The first component 12 has two bridge portions 128 that divide the insertion opening 124 from both sides. Each bridge portion 128 is provided with a through hole 92. The through hole 92 expands in diameter in a direction away from the male connecting portion 126 to receive the head 100 of the connecting screw 98.

[0086] A body portion (unthreaded shaft portion) 96 passes through the through hole 92. A threaded portion (threaded shaft portion) 102 extending between the body portion 96 and a free end 104 of the connecting screw 98 is provided with male threads that correspond to the female threads 108 of the through hole 106. This allows the threaded portion 102 of the connecting screw 98 to be screwed into the female threads 108 of the through hole 106.

[0087] The above-mentioned configuration of the connecting device 58 allows both biasing elements 56 to be compressed individually between the respective first bearing surface area 52 and the corresponding second bearing surface area 4 .

[0088] The medical device 10 described in relation to Figures 1 to 7 on the one hand and Figures 23 and 24 on the other hand may be provided with any of the above-mentioned biasing elements 56 in the form of a spring washer 64. The wave washer 68 according to any of the above-mentioned embodiments is suitable to be arranged between the first and second bearing surface areas 52, 54 of the above-mentioned medical device 10.

[0089] The spring washers described above have a preferred thickness 74 in the range of about 0.05 mm to about 0.2 mm. Because the medical instrument 10 needs to be washable and sterilizable, the spring washers 64 are preferably made from stainless spring steel.

[0090] If desired, the biasing element 65 described above may be coated or formed with a hardened surface by a suitable process (e.g., diffusion hardening or blasting to provide additional hardness to improve the dry running characteristics of the biasing element 56).

[0091] As described above, the gaps defined by the valleys (wave valleys) 70 and the peaks (wave ridges) 72 are closed or nearly closed by compression of the biasing element 56 during assembly of the medical device 10, so that the impact on the cleanability of the medical device 10 is quite limited.

[0092] Furthermore, in order to avoid increased friction between the first and second parts 12, 14 and the biasing element 56, the biasing element 56 is preferably made from a material that is harder or harder compared to the material of the first and second parts 12, 14. This creates a difference between the hardness of the first and second parts 12, 14 and the hardness of the biasing element 56.

[0093] The medical device 10 according to the above-described embodiment has the advantageous property of, among other things, maintaining a perceptible operating force that is deemed comfortable by the surgeon over its entire lifespan. Even if the medical device 10 becomes worn in the area of ​​the connecting device 58, in most cases reconditioning of the medical device 10 is not necessary because the biasing element 56 maintains the desired operating force.

[0094] Furthermore, if the medical instrument 10 becomes damaged and requires repair and / or maintenance, the biasing element 56 is easily replaceable without the need for reworking (e.g., milling, grinding, polishing) of the operating surfaces (gliding surfaces). [Explanation of symbols]

[0095] 10 Medical Equipment 12 First Part 14 2nd Part 16 First Distal End 18 first proximal end 20 First Tool Element 22 first gripping element 24 Second Distal End 26 Second proximal end 28 Second Tool Element 30 Second gripping element 32 Medical Tools 34 Clamp jaw 36 Clamp jaw 38 Medical Clamps 40 Ring 42 Ring 44 Connection Area 46 Connection Elements 48 Arm 50 Arm 52 1st support surface area 54 Second support surface area 56 Actuating element 58 Connection Device 60 Swivel Axis 62 Longitudinal axis 64 Spring washer 66 Central opening 68 Wave washer 70 Tanibe (Hatani) 72 Yamabe (Namiyama) 74 Thickness 76 First Surface 78 Second Surface 80 First contact surface 82 Second Contact Surface 84 Cutting line 86 Inflection Point 88 Inflection Point 90 Clockwise 92 Through hole 94 Expanded area 96 Torso 98 Connection screw 100 heads 102 Threaded part 104 Free end 106 Through hole 108 Female thread 110 First Distance 112 Second Distance 114 Press-type connection device 116 Radial 118 Needle Holder 120 Box-type connection device 122 Female connector 124 Insertion opening 126 Male connector 128 Bridge section

Claims

1. A medical device (10) comprising a first part (12) and a second part (14) connected by a connecting element (46) so as to be able to pivot relative to each other about a pivot axis (60) defined by the longitudinal axis (62) of the connecting element (46), The first component (12) has at least one first support surface region (52), and the second component (14) has at least one second support surface region (54), and the at least one first support surface region (52) and the at least one second support surface region (54) are arranged to face each other. The at least one first support surface region (52), the at least one second support surface region (54), and the connecting element (46) define a connecting device (58). In the installed state, a biasing element (56) is positioned between the at least one first support surface region (52) and the at least one second support surface region (54). The biasing element (56) is held in a compressed state between the at least one first support surface region (52) and the at least one second support surface region (54) by the connecting element (46) so as to exert a biasing force on the at least one first support surface region (52) and the at least one second support surface region (54) to maintain a state in which the at least one first support surface region (52) and the at least one second support surface region (54) are biased toward each other in the mounted state. A medical device characterized by the following features.

2. The biasing element (46) is configured in the form of a spring washer (64) having a central opening (66) for receiving the connecting element (46), The biasing element (56) is arranged to surround the pivot axis (60), The medical device according to feature 1.

3. The spring washer (64) is configured in the form of a wave washer (68). The medical device according to feature 2.

4. The wave washer (68) has a wave-like shape that defines at least one valley (70) and at least one peak (72). The medical device according to feature 3.

5. The wave washer (68) has the wave shape defining the at least one valley (70) and the at least one peak (72) in an initial state in which the wave washer (68) is separated from the first support surface region (52) and the second support surface region (54) so ​​as not to exert any spring force. The medical device according to feature 4.

6. The wave washer (68) has a constant or substantially constant thickness (74), A medical device according to any one of claims 3 to 5, characterized by the features described herein.

7. The wave washer (68) has a wave-like shape along the circumferential direction (90) with respect to the pivot axis (60), or a wave-like shape along the radial direction (116) with respect to the pivot axis (60). A medical device according to any one of claims 3 to 5, characterized by the features described herein.

8. The cutting line (84) of the wave washer (68) along the radial direction (116) or circumferential direction (90) with respect to the pivot axis (60) has at least two inflection points (86, 88). A medical device according to any one of claims 3 to 5, characterized by the features described herein.

9. The wave washer (68) has a first surface (76) and a second surface (78) facing in opposite directions. The first surface (76) defines a first contact surface (80) consisting of the ridges (72), The second surface (78) defines a second contact surface (82) consisting of the valley portion (70). The medical device according to feature 4.

10. The first contact surface (80) and the second contact surface (82) extend parallel or substantially parallel to each other. The medical device according to feature 9.

11. The first contact surface (80) and the second contact surface (82) are initially positioned at a first distance (110) from each other. The first contact surface (80) and the second contact surface (82) are positioned apart from each other at a second distance (112) greater than the first distance (110) in the mounting state in which the biasing element (56) is attached between the at least one first support surface region (52) and the at least one second support surface region (54). A medical device as described in claim 9 or 10.

12. (a) In the mounting state, the maximum value of the second distance (112) is approximately 1.2 times the thickness (74) of the wave washer (68), and / or (b) In the initial state, the first distance (110) is within the range of approximately 2 to 10 times the thickness (74) of the wave washer (68). The medical device according to feature 11.

13. The connecting element (46) is configured in the form of a press-type connecting device (58) having a single first support surface region (52) and a single second support surface region (54), The first component (12) having the single first support surface region (52) is pressed against the single second support surface region (54) with the biasing element (56) positioned between the single first support surface region (52) and the single second support surface region (54). A medical device according to any one of claims 1 to 5, characterized by the following:

14. The aforementioned connecting element (46) is configured in the form of a box-shaped connecting device (120), The first component (12) is equipped with a female connector (122) having an insertion opening (124), The second part (14) has a male connector (126), In the aforementioned mounting state, the male connector (126) extends through the insertion opening (124), A medical device according to any one of claims 1 to 5, characterized by the following:

15. The female connector (112) has two first support surface regions (52) facing each other, The male connector (126) has two second support surface regions (54) facing away from each other. The medical device according to feature 14.

16. A method for manufacturing a medical device comprising a first component (12) having at least one first support surface region (52) and a second component (14) having at least one second support surface region (54), The steps include arranging the at least one first support surface region (52) and the at least one second support surface region (54) so ​​that they face each other, The system includes the step of connecting the first part (12) and the second part (14) with the connecting element (46) so that the first part (12) and the second part (14) can pivot relative to each other about a pivot axis (60) defined by the longitudinal axis (62) of the connecting element (46), Before the step of connecting the first part (12) and the second part (14) to each other, The steps include: arranging a biasing element (56) between the at least one first support surface region (52) and the at least one second support surface region (54); The steps include compressing the biasing element (54) with the first part (12) and the second part (14) to bring it into a compressed state, The method further comprises the step of maintaining the compressed state by adjusting the connecting element (46) such that the biasing element (56) continuously applies a biasing force to the at least one first support surface region (52) and the at least one second support surface region (54) to maintain a state in which the at least one first support surface region (52) and the at least one second support surface region (54) are biased toward each other. A method for manufacturing medical devices.

17. Use of a wave washer (68) as a biasing element (56) in the method for manufacturing a medical device according to Claim 16, or as a biasing element (56) in a medical device (10) according to any one of Claims 1 to 5.

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