Medical measuring system and method for production of the measuring system

Abstract

The invention relates to a medical technology measuring system (1) comprising a measuring device (10) for measuring a characteristic of a fluidin particular, for pressure measurementwherein the measuring device comprises a lead (20) which extends along a central longitudinal axis (M) and is equipped to guide a fluidin particular, bloodinside a longitudinal cavity (24) enclosed by a wall, and a sensor device (30) comprising a sensor (32) which is equipped to measure a characteristic of the fluid guided in the longitudinal cavity, wherein the measuring system (1) has an overmolding (9) which at least partially surrounds the measuring device (10)preferably, both at least the sensor device (30) and also a section of the lead (20). As a result, the measuring device can be fastened and positioned on the lead in a simple and/or reliable, robust manner. The invention further relates to a method for producing such a medical technology measuring system.

Claims

1. A medical technology measuring system, comprising: a measuring device for measuring a characteristic of a fluid, wherein the measuring device comprises: a lead, which extends along a central longitudinal axis and is configured to guide a fluid within a longitudinal cavity bounded by a wall, and a sensor device with a sensor, which is equipped to measure a characteristic of the fluid guided in the longitudinal cavity; and an overmolding at least partially surrounding the measuring device, wherein the lead has a radial cavity incorporated in the wall in a radial direction, and at least the sensor of the sensor device is arranged and is integrated in the wall such that the sensor is in communication with the fluid guided in the longitudinal cavity.

2. The measuring system according to claim 1, wherein the overmolding surrounds both at least the sensor device and a section of the lead.

3. The measuring system according to claim 1, wherein the overmolding is provided on the lead such that the overmolding surrounds at least the sensor device of the measuring device, wherein at least the sensor device is positioned and embedded in a predefined position relative to the lead in the overmolding.

4. The measuring system according to clam 1, wherein the overmolding is made of a hotmelt adhesive.

5. The measuring system according to claim 4, wherein the overmolding is made of a mixture of polyester and hydrocarbon resin, with a greater part polyester than hydrocarbon resin.

6. The measuring system according to claim 1, wherein the overmolding is configured to adhere to an outer lateral surface of the wall by mechanical adhesion.

7. The measuring system according to claim 1, wherein the overmolding completely surrounds at least the lead on at least two sections of the overmolding spaced apart from one another.

8. The measuring system according to claim 1, wherein the overmolding completely surrounds at least the lead on two free ends of the overmolding arranged at a maximum distance from one another.

9. The measuring system according to claim 1, wherein the overmolding has an extension or edge on a proximal and/or distal end or section of the overmolding, which comes into contact on an outer lateral surface of the wall.

10. The measuring system according to claim 1, wherein the overmolding has an opening extending in a radial direction, at least approximately vertically to the central longitudinal axis, wherein the opening provides a connection between the sensor and the surroundings.

11. The measuring system according to 10, wherein the measuring system has an adapter cable connected to the sensor device, the adapter cable being embedded in the overmolding, and the adapter cable being arranged with an excess length in a serpentine line in the overmolding.

12. The measuring system according to claim 1, wherein the measuring system has a receptacle, and wherein the overmolding at least partially surrounds the receptacle and is also disposed between the lead and the receptacle.

13. The measuring system according to claim 1, wherein the measuring device is a disposable device provided for single use, wherein the sensor device has a coupling point for communication and/or a power supply for a wired transmission via a cable or for a wireless transmission.

14. The measuring system according to claim 1, wherein the fluid is blood.

15. The measuring system according to claim 1, wherein the characteristics of the fluid is pressure.

16. A method for producing a measuring system according to claim 1, comprising the steps of: providing a lead equipped to guide a fluid; arranging a sensor device of the measuring system on an outer lateral surface of a wall of the lead; arranging the measuring system with the lead in a tool; overmolding at least the sensor device and the lead, at least in sections, with a material based upon polyester and hydrocarbon resin.

17. The method according to claim 16, wherein the step of overmolding comprises two steps: overmolding at least the sensor device such that the sensor device is provided in a functional arrangement, and overmolding at least the lead, wherein the overmolding is brought into a final form, and wherein, prior to overmolding, a mandrel is inserted into the lead.

18. The method according to claim 17, wherein the lead is fastened on a retaining bracket or a retaining clip of the negative mold of the tool.

19. The method according to claim 16, wherein the step of arrangement in the tool further comprises: a relative positioning of the sensor device relative to the tool in relation to a negative mold for the formation of an opening in the overmolding, wherein the lead is fastened on at least one holding fixture of the tool.

20. A medical technology measuring system, comprising: a measuring device for measuring a characteristic of a fluid, wherein the measuring device comprises: a lead, which extends along a central longitudinal axis and is configured to guide a fluid within a longitudinal cavity bounded by a wall, and a sensor device with a sensor, which is equipped to measure a characteristic of the fluid guided in the longitudinal cavity; and an overmolding at least partially surrounding the measuring device, wherein the overmolding has an opening extending in a radial direction, at least approximately vertically to the central longitudinal axis, the opening providing a connection between the sensor and the surroundings, the measuring system has an adapter cable connected to the sensor device, the adapter cable being embedded in the overmolding, and the adapter cable being arranged with an excess length in a serpentine line in the overmolding.

21. A medical technology measuring system, comprising: a measuring device for measuring a characteristic of a fluid, wherein the measuring device comprises: a lead, which extends along a central longitudinal axis and is configured to guide a fluid within a longitudinal cavity bounded by a wall, and a sensor device with a sensor, which is equipped to measure a characteristic of the fluid guided in the longitudinal cavity, and an overmolding at least partially surrounding the measuring device, wherein the measuring device is a disposable device provided for single use, and the sensor device has a coupling point for communication and/or a power supply for a wired transmission via a cable or for a wireless transmission.

22. A medical technology measuring system, comprising: a measuring device for measuring a characteristic of a fluid, wherein the measuring device comprises: a lead, which extends along a central longitudinal axis and is configured to guide a fluid within a longitudinal cavity bounded by a wall, and a sensor device with a sensor, which is equipped to measure a characteristic of the fluid guided in the longitudinal cavity; and an overmolding at least partially surrounding the measuring device, wherein the measuring system has a receptacle, and wherein the overmolding at least partially surrounds the receptacle and is also disposed between the lead and the receptacle.

Description

BRIEF DESCRIPTION OF THE FIGURES

(1) FIG. 1 shows, in schematic representation in perspectival cutaway view, a measuring system according to one exemplary embodiment of the invention;

(2) FIGS. 2A, 2B, 2C each shows, in a perspectival view, a protective cap for covering a sensor device of the measuring system shown in FIG. 1, or a membrane for the protective cap;

(3) FIGS. 3A, 3B, 3C each shows, in a perspectival view, a receptacle for connecting a sensor device of the measuring system shown in FIG. 1 to an energy source and/or to communications means, e.g., via a cable or a wireless connection;

(4) FIGS. 4A and 4B show, in a perspectival view and in a perspectival cutaway view, individual components of the measuring system shown in FIG. 1;

(5) FIG. 5 shows, in schematic representation in perspectival cutaway view, a measuring system according to one exemplary embodiment of the invention, wherein an overmolding is illustrated;

(6) FIGS. 6A and 6B each shows, in a perspectival view, a measuring system according to one exemplary embodiment of the invention;

(7) FIGS. 7A and 7B each shows, in a perspectival view, a measuring system according to a further exemplary embodiment of the invention; and

(8) FIG. 8 shows, in schematic representation, a method diagram for steps of a method according to exemplary embodiments of the invention.

(9) FIG. 9 shows, in schematic representation, in view of the underside, a measuring system according to one exemplary embodiment of the invention, wherein an overmolding is illustrated.

DETAILED DESCRIPTION OF THE DRAWINGS

(10) FIG. 1 shows a medical technology measuring system 1 comprising a lead 20 extending in longitudinal direction along a central longitudinal axis M and a measuring device 10 with a sensor device 30. The lead 20 is explained in FIG. 1 using the example of a hose lead. The sensor device 30 has a sensor 32 which is arranged in a radial cavity 26 within a wall 22 of the lead 20. The radial cavity 26 extends in radial direction r and is designed in the shape of an opening, a hole, or a borehole in the wall 22. The sensor 32 is configured to measure a characteristicin particular, a pressure of a fluid guided in a longitudinal cavity 24 within the lead 20. The measuring system 1 further comprises a receptacle 5 and a button 7.

(11) The measuring system 1 has an overmolding 9, which surrounds the sensor device 30 and, at least partially, also the receptacle 5 and the button 7. The overmolding 9 is in contact with the wall 22, at least in sections. The overmolding 9 surrounds the wall 22, at least in sectionsin particular, at three different points, viz., right at the front, approximately in the middle, and at the rear of the arrangement depicted. The overmolding 9 has an aperture 9.1 or an opening, through which the sensor 32 is in communication with the surroundings U. The aperture 9.1 is arranged in the region of a cover/protective cap 14in particular, in the region of a membrane 16 of the sensor device 30and extends essentially in a radial direction.

(12) In FIGS. 2A, 2B, and 2C, the components protective cap 14 and membrane 16 are shown in detail. The protective cap 14 has an opening 14.1in particular, in the shape of a vent bore. The preferably gas-permeable, fluid-tight membrane 16 is arranged above the opening 14.1 and covers it completely. The membrane 16 can in the process be fastened at several points on an outer edgein particular, on lugs or hooks protruding inward in a radial direction.

(13) In FIGS. 3A, 3B, and 3C, the components receptacle 5 and button 7 are shown in detail. The button 7 can be arranged on the receptacle 5. An underside of the button 7 is designed to geometrically correspond to an upper side of the receptacle 5.

(14) In FIGS. 4A and 4B, yet another component of the measuring device 10 is shown. The measuring device 10 also comprises an adapter cable 3, which is arranged between the receptacle 5 and the sensor device 30 and which connects the sensor device 30 electrically to a power supply and/or communications interface (not shown). The adapter cable 3 is arranged in loops or windings or in a serpentine manner, with excess length between the receptacle 5 and the sensor device 30, as a result of which relative movements, due, for example, to a bend of the lead 20, can be compensated for.

(15) FIG. 4B shows in detail that the sensor device 30 is in contact with an outer lateral surface 22.1 of the lead 20, whereas the adapter cable 3 and the receptacle 5 are embedded in the overmolding, as shown in FIG. 5.

(16) FIG. 5 shows the overmolding 9 in cross-section. The adapter cable 3 and the receptacle 5 are embedded in the overmolding 9 and do not touch the lead 20. As a result, friction from these components on the wall 22 can be prevented. Between the receptacle 5 and the wall 22, an intermediate section 9.3 is designed, which positions the receptacle 5 relative to the wall 22. In contrast to this, the sensor device 30 has a contact section 38 which is arranged outside on the wall 22 and is preferably firmly bonded to the wall 22. In this way, the radial position of the sensor 32 within the radial cavity 26 can bedefined in an exact manner, and a relative movement between the wall 22 and the sensor device 30 can be avoided. This can ensure a good fluid-tightness and a clear position of the sensor 32, and thus an exact measurement. Simultaneously, the overmolding 9 can ensure that no radial or axial forces are exerted externally on the sensor device 30. The overmolding 9 can protect the sensor device 30 from external influences and ensure the predefined position of the sensor device 30 relative to the wall 22 by preventing relative movements between the sensor device 30 and the wall 22.

(17) On an underside of the wall 22, the overmolding has 9 two recesses 9.2. These recesses 9.2 can, on the one hand, minimize material consumption; on the other hand, a flexibility of the lead 20 can be maintained, or tension due to deformations in the overmolding can be minimized.

(18) In FIGS. 6A and 6B, the overmolding 9 is shown from a view of a rear, proximal side, at which the receptacle 5 can be connected to a cable or a (communications) stick. The receptacle 5 shown in the figures is configured to receive either a connector together with an (external) cable, or a type of stick or module. The stick can ensure a wireless communication, e.g., via WLAN, radio, or Bluetooth. The stick can also have a power supply, e.g., a battery. The receptacle 5 can, in the process, have the same shape for both variants, so that a user can decide whether a wired power supply and communication is desired, or whether the communication should take place wirelessly and the power supply should take place via the stick, e.g., by means of batteries integrated the stick. Both the cable and the stick can, in the process, be used multiple times. In other words, the medical technology measuring system 1 or the medical technology measuring device 10 can be provided for a single (disposable) use, and, prior to disposal, the cable or the stick can then be decoupled from the receptacle.

(19) The overmolding 9 surrounds the lead 20 completely. At an upper side, the overmolding 9 has a notch or a recess 9.4 for receiving the button 7. A proximal front end section 9.5 of the overmolding 9 is arranged on the same radial plane as a proximal end of the receptacle 5. The overmolding 9 and the receptacle 5 are arranged flush, on the same plane. This can ensure a compact arrangement, and edges or protrusions can be integrated in the overmolding 9, so that a user does not come into contact with the edges.

(20) The overmolding 9 has several surface sectionsin particular, four different surface sections. A surface section 9a on the upper side provides coverage and the aperture 9.1. Lateral surface sections 9b, 9c provide flanks or holding surfaces, at which the overmolding 9 can be grasped and held in an ergonomic manner. A surface section 9d on the lower side provides a roundness and an underside, upon which the overmolding 9 can be placed, e.g., in the case of connecting the receptacle 5 to a cable. The respective lateral surface section 9b, 9c adjoins on an edge 9.6 the lower surface section 9d. The edge 9.6 extends in a longitudinal direction along the entire overmolding 9 and can provide an ergonomic negative mold for the inner surface of a human hand. In cross-section, the overmolding 9 is designed in the shape of a rhombus with convex, round surface sections.

(21) FIGS. 7A and 7B show an exemplary embodiment in which the overmolding 9 has an extension 9.7. The extension 9.7 is provided on a distal end of the overmolding and comes into contact with an/the outer lateral surface 22.1 of the wall 22. Optionallyand also, in additionthe extension can also be provided on a proximal end of the overmolding.

(22) FIG. 9 shows an exemplary embodiment in which the overmolding 9 has a continuous slot 9.8 on an underside of the wall 22 running parallel to the longitudinal extension of the wall 22. This slot 9.8 is broadened to a window 9.9 in a central region, as a result of which, in this region, the wall 22 is continuously visible. If the wall 22 is made of a transparent material, then a constant view of the sensor 32 is possible in the radial cavity 26 of a fluid guided in the lead 20. Further, the slot 9.8 can also act as an expansion joint in a longitudinal direction, which rules out the danger of a movement related crack formation.

(23) FIG. 8 shows steps of a method for producing a medical technology measuring system. The method comprises one or more of the steps described in the following.

(24) In a step S1, provision is made for a lead that is equipped to guide a fluid in particular, blood. In a step S2, placement of a radial cavity in a wall of the lead occurs, e.g., by boring. In a step S3, an arrangement of a sensor device and, optionally, further components of the measuring system on the lead occursin particular, on an outer lateral surface of the wall. In the process, the measuring device can be fixed on the wall in a step S3.1in particular, in a firmly bonded manner by means of an adhesive agent. Further, the radial cavity can be sealed in a step S3.2 in particular, by means of a radial section of the sensor device forming an interference fit with the radial cavity. In the process, an adhesive agent is preferably not provided. Steps S3.1 and S3.2 can be carried out independently of one another or in combination with one another. In a subsequent Step S4, an overmolding tool can be provided and the measuring system can be arranged together with the lead in the overmolding tool. In the process, in a step S4.1, a negative mold and a holding fixture of the tool may be provided A retaining bracket or retaining clip may also be provided at this step. A relative positioning of the sensor device in the overmolding tool can take place in particular, in relation to a protruding (in particular, radially aligned) pin or in conjunction with an arrangement of the pin for the formation of an opening in the overmolding. In addition, in a step S4.2, at least one further component of the measuring system in particular, a receptacle and/or an adapter cable-can also be arranged in the overmolding tool, and, in a step S4.3, positioned relative to the overmolding tool, and/or, in a step S4.4, the receptacle can be positioned relative to the outer lateral surface of the wall.

(25) The receptacle of the measuring system can be positioned relative to the lead in the case of arrangement on the lead, and, optionally, in conjunction with a button and/or an adapter cable. The receptacle can, in the process, be positioned spaced at a radial distance to an outer lateral surface of the wall. Preferably, the radial distance is at least 1.0 mm. It turns out that this distance is sufficiently large that the overmolding material can be placed in the intermediate space between the wall and the receptacle.

(26) In a step S5, the individual components can be connected to one another. In particular, the sensor device can be connected to an adapter cable, and the adapter cable can be connected to the receptacle. The step S5 can, in the process, also be carried out before the step S4.

(27) After the arrangement of the measuring system in the tool has taken place, and the tool has been closed, in a step S7, an overmolding can occur. The step S7 can, in the process, be characterized by the following steps: Step S7a, corresponding to a procedural step of a pre-overmolding (first overmolding step), Step S7b, corresponding to a procedural step of a main overmolding (second overmolding step), Step S7.1, corresponding to a procedural step of setting a specific temperature in the case of overmolding, Step S7.2, corresponding to a procedural step of setting a specific pressure in the case of overmolding. Optionally, prior to overmoldingin particular, also prior to Step S4 in a step S6, a mandrel can be provided and an arrangement of the mandrel in a longitudinal cavity of the lead can take place. The overmolding can, in the process, be controlled by setting a specific temperature (Step 7.1) and/or by setting a specific pressure (Step 7.2). Finally, in a step S8, a demolding can take placein particular, after a predetermined cooling time.

LIST OF REFERENCE SYMBOLS

(28) 1 Medical technology measuring system

(29) 3 Adapter cable

(30) 5 Receptacle

(31) 7 Button

(32) 9 Overmolding

(33) 9a Surface section on the upper side

(34) 9b, 9c Lateral surface section

(35) 9d Surface section on the lower side

(36) 9.1 Opening or aperture in overmolding

(37) 9.2 Recess on underside

(38) 9.3 Intermediate section

(39) 9.4 Recess or notch on upper side

(40) 9.5 Proximal front end or front end section

(41) 9.6 Edge

(42) 9.7 Extension or edge

(43) 9.8 Slot

(44) 9.9 Window on underside

(45) 10 Medical technology measuring device

(46) 14 Coverin particular, protective cap

(47) 14.1 Openingin particular, vent bore

(48) 16 Gas-permeable, fluid-tight membrane

(49) 20 Leadin particular, a hose lead

(50) 22 Wall

(51) 22.1 Outer lateral surface of the wall

(52) 24 Longitudinal cavity along the central longitudinal axis for guiding the flid

(53) 26 Radial cavityin particular, opening or recess

(54) 30 Sensor device

(55) 32 Sensor

(56) 38 Contact section

(57) M Central longitudinal axis

(58) r radial direction

(59) S1 Procedural step of providing a lead

(60) S2 Procedural step of placing a radial cavity

(61) S3 Procedural step of arranging a sensor device on the lead

(62) S3.1 Procedural step of affixing the sensor device on the lead

(63) S3.2 Procedural step of sealing the radial cavity by means of the sensor device

(64) S4 Procedural step of arranging the measuring system with the lead in an overmolding tool

(65) S4.1 Procedural step of relative positioning of the sensor device in the overmolding tool

(66) S4.2 Procedural step of arranging at least one further component of the measuring system in the overmolding tool

(67) S4.3 Procedural step of relative positioning of the receptacle in the overmolding tool

(68) S4.4 Procedural step of relative positioning of the receptacle relative to the outer lateral surface of the wall

(69) S5 Procedural step of connectionin particular, electrical connectionof individual components of the measuring system to one another

(70) S6 Procedural step of arranging a mandrel in the longitudinal cavity of the lead

(71) S7 Procedural step of overmolding

(72) S7a Procedural step of a pre-overmolding (first overmolding step)

(73) S7b Procedural step of a main overmolding (second overmolding step)

(74) S7.1 Procedural step of setting a specific temperature in the case of overmolding

(75) S7.2 Procedural step of setting a specific pressure in the case of overmolding

(76) S8 Procedural step of demolding

(77) U Surroundings