Medical procedure kit

Abstract

A medical operating kit is described for connecting two implants arranged spatially apart from one another by means of a flexible connecting line, along which a mechanical interface of the plug-and-socket connection type is arranged. The operating kit comprises a tube and a stylet guided inside the tube, the stylet being arranged with a stylet tip of the stylet that is releasably fixedly seated on a distal end by means of a first engagement connection, the stylet tip protruding beyond the tube end of the distal end in the engaged state, a first engagement profile seated on the stylet region of the distal end, the first engagement profile being part of a second engagement connection, and an adapter element having a counter-profiled mating engagement profile to the first engagement profile for forming the second engagement connection, and the adapter element having a second engagement profile counter-profiled to the plug part or the socket part of the mechanical interface, the second engagement profile being part of a third engagement connection.

Description

Technical Field

[0001] This invention relates to a medical manipulation kit for connecting two spatially separated implants via a flexible connecting line, along which a mechanical interface is provided according to a plug-and-socket connection type. Background Technology

[0002] Implantable medical devices for electrically stimulating localized areas of the body, such as defibrillation applications, pacemaker applications, and resynchronization applications for cardiac treatment, and transiently implantable pulse generators (IPGs) for neurostimulation therapies, such as spinal cord stimulation, brain stimulation, or vagus nerve stimulation (to name just a few), typically have a fluid-sealed housing containing components for generating electrical pulses, i.e., at least one electrical energy source in the form of a battery or induction coil, and a circuit structure connected to said electrical energy source. Furthermore, a so-called head portion is mostly connected to the housing, containing electrical contact components electrically connected to the energy source or circuit structure. A plug assembly, fluid-sealed and closed to the head portion, can engage with these electrical contact components. This plug assembly is electrically connected via input and output wires to at least one separate in vivo electrode assembly for locally applying electrical stimulation signals and outputting locally measured electrical signals to the circuit structure located on the housing side. The input and output wires typically form flexible connecting lines.

[0003] Publication EP 3 204 105 B1 discloses an implantable electrode assembly that is locally applied in the form of a skin electrode assembly in the neck region near the vagus nerve for electrical stimulation of selected nerve fibers along the vagus nerve. An implant housing, or IPG (Implantable Pulse Generator), is located opposite the electrode assembly and includes all the components necessary for the operation and function of electrical stimulation in a surgically accessible area, preferably below the clavicle.

[0004] To facilitate the implantation of both the sclerotherapy electrode assembly and the IPG, two skin incisions are made: one in the chest region for closure of the IPG and another in the neck region for placement of the sclerotherapy electrode assembly along the vagus nerve. Typically, the sclerotherapy electrode assembly has a flexibly constructed electrical connection wire fixedly disposed on one side, with an electrical interface, preferably in the form of a multi-polar plug portion, arranged at the wire end opposite the sclerotherapy electrode assembly. This plug portion is adapted to engage with a socket portion disposed on the IPG.

[0005] To minimize the burden associated with the surgical procedure performed on the patient, there is a need to place flexible electrical connections within the body between the IPG and the skin electrode assembly in a manner as harmless as possible. The procedure required for this should be reliably and error-free for the surgeon in the shortest possible time.

[0006] Publication US 2013 / 0324994 A1 discloses a system for modulating the nerves of a limb, the system mainly comprising a tube and a core needle guided within the tube, the core needle having a core needle tip fixedly positioned in a distal core needle region, the core needle tip protruding from the distal end of the tube. Summary of the Invention

[0007] The objective of this invention is to provide a medical manipulation kit for connecting two spatially separated implants via flexible connecting lines, along which mechanical interfaces of a plug-and-socket connection type are provided, such that the two implants, enclosed in different areas of the body, should be connected via electrical connections in a way that is harmless to the patient, i.e., without or with minimal dermatopathological irritation. The necessary medical aids should also enable the surgeon to perform intuitive, error-free, and rapid operations.

[0008] The solution to the problem of the present invention is given in claim 1. Features that further improve the inventive concept in an advantageous manner are those described in the dependent claims and, in particular, with reference to the embodiments.

[0009] The medical manipulation kit according to the solution is used to connect two spatially separated implants via a flexible electrical connection line, along which a mechanical interface of a plug-and-socket connection type is provided. The medical manipulation kit includes a tube and a core guided in the tube. The core is provided with a core tip that is releasably and securely positioned on a distal core region via a first engagement connection. The core tip protrudes from the distal end of the tube in the engagement state.

[0010] Preferably, the tip of the needle is flush with, and preferably fluid-tightly connected to, the distal end of the tube, thereby preventing bodily fluids, particularly blood, from entering the lumen of the tube during tissue permeation.

[0011] The tip of the mandrel is positioned on the distal mandrel region via a releasably secure first engagement connection. The first engagement connection is preferably formed in the form of a threaded-reverse thread connection or a bayonet connection, so as to ensure, on the one hand, that the tip of the mandrel is securely positioned on the mandrel during surgical intervention, and on the other hand, that the surgeon can easily and quickly remove the tip of the mandrel from the distal mandrel region.

[0012] The distal core needle region also has a first engagement profile, which is part of a second engagement connection, which is preferably different in shape and configuration from the first engagement connection.

[0013] The medical operation kit according to the solution also includes a separate adapter element having a mating engagement profile constructed in reverse of the first engagement profile for forming a second engagement connection. The adapter element also has a second engagement profile constructed in reverse of the plug or socket portion of the mechanical interface and adapted to form a third engagement connection. Unlike the first engagement connection between the needle tip and the distal needle region, the second and third engagement connections are constructed similarly in shape and configuration and are preferably based on a latching mechanism and / or a locking mechanism.

[0014] In a preferred embodiment, the first engagement profile has a head-like structure on the distal mandrel region, which engages pressure-supported with a concave mating engagement profile disposed on the adapter element, producing an audibly perceptible snap sound. Alternatively, the first engagement profile on the distal mandrel region may be concave, and a correspondingly de-contoured head-like structure on the adapter element side may engage pressure-supported with the first engagement profile. Auditory perception is based on a pulsed engagement collision caused by a collision effect between the two mating pairs, and this collision occurs only upon successful engagement, so that the engagement sound perceptible to the surgeon can be evaluated as a confirmation signal of successful engagement. This auditory feedback confirmation is valuable to the surgeon, who, due to the small size and narrow space, does not need to constantly observe the instruments during surgery.

[0015] The second engagement profile disposed on the adapter element is at least partially constructed in a reverse-profile manner to the plug portion or socket portion disposed on the flexible connector end side, thereby enabling the plug portion or socket portion to be inserted on one side into the second engagement profile disposed on the adapter element and to be axially fixed and torsionally releasable and fixedly fastened to the adapter element by means of a locking mechanism or latching mechanism. For this purpose, the second engagement profile disposed on the adapter element specifically matches the configuration of the plug portion or socket portion. Alternatively, in the case of the plug portion disposed on the flexible connector end side, the second engagement profile is constructed in the form of a blind hole arrangement, and the tenon-shaped plug portion can be releasably and fixedly engaged into the second engagement profile. In the case of the socket portion disposed on the flexible connector, the second engagement profile disposed on the adapter element is constructed in a plug-like manner for releasably and fixedly engaging into the socket portion.

[0016] In order to secure the third engagement connection formed between the adapter element and the plug or socket portion disposed on the flexible connecting line, the second engagement profile has at least one claw that abuts against the outer profile disposed on the plug or socket portion in a shape-fitting and / or force-fitting manner.

[0017] Preferably, the adapter element is cylindrically constructed, having a mating engagement profile on one side and a second engagement profile on the other side at its two opposing cylindrical end regions along the cylindrical axis. Furthermore, the adapter element and the flexible connecting wire are constructed such that the engagement profile of the plug or socket portion has a maximum cross-sectional diameter in the engaged state, said maximum cross-sectional diameter being smaller than the determined size of the cross-section configured for the tube, so that the adapter element can be axially and completely pulled into and through the tube while forming the second and third engagement connections.

[0018] A preferred embodiment is shown in the following figures. Attached Figure Description

[0019] The invention will now be described by way of example with reference to the accompanying drawings, without limiting the general inventive concept. In the drawings:

[0020] Figure 1 The diagram shows a tube with a guide needle inside and a distal tip in the needle region.

[0021] Figure 2 A view of the adapter components is shown.

[0022] Figure 3 An adapter element with an inserted plug portion is shown, the adapter element being disposed on the end side of a flexible connecting wire, and...

[0023] Figure 4 A tube with a guide needle inside is shown, and an adapter element is disposed on the tip of the guide needle. Detailed Implementation

[0024] Figure 1 The diagram shows a tube 1 constructed as a hollow channel, with a mandrel 2 supported inside the tube. The proximal end of the mandrel is shaped like a handle for manual operation and provides the surgeon with the possibility of applying axial tensile and thrust forces along the mandrel 2 and the tube 1, as well as distributing torque oriented about the longitudinal axis of the mandrel.

[0025] The proximal end of tube 1 is releasably and securely placed on a mechanical stop 4 mounted on a mandrel 2, through which the thrust acting on the mandrel 2 is transmitted to tube 1. The mandrel 2 is releasably and securely connected to the mandrel tip 5 at its distal mandrel region via a first engagement connection 6. The first engagement connection 6 is preferably a threaded-reverse thread connection or a bayonet connection, in which the mandrel tip 5 is releasably and securely engaged with the distal mandrel region of the mandrel 2. For this purpose, the mandrel 1 has, for example, an external thread at its distal mandrel region, which mates with the internal thread of the mandrel tip 5.

[0026] Figure 1 The medical device shown, consisting of a tube 1 and a guide needle 2 internally guided, is used for intra-in vivo cannulation, that is, to introduce a puncture channel through a tissue region within the body. The tip 5 of the guide needle is fluid-tightly abutted against the distal end of the tube. Combined with the skin electrode assembly and IPG implantation described at the beginning, Figure 1 The medical device shown is inserted into the skin near the surface of the inserted cannula as harmlessly as possible from the chest region toward the implanted skin electrode assembly to establish a connection channel. The electrical connection between the skin electrode assembly and the IPG should extend along the connection channel.

[0027] After the catheterization is completed, the tip 5 of the catheter extends outward from the opening in the body in the area introduced into the vagus nerve, allowing the surgeon to separate the tip 5 from the distal catheter region by releasing the first ligature. Then... Figure 2 and 3 The adapter element 7 shown is engaged with the distal core needle region.

[0028] For this purpose, the core needle 2 has a first engagement profile 8 on the distal side, see Figure 3 The first engagement contour is head-shaped. In contrast, the adapter element 7 has a mating engagement contour 9 on one side that is constructed in reverse of the first engagement contour 8. Figure 2 and 3 In the configuration shown, it is constructed in the form of a concave groove. The mating engagement profile 9 has a bottleneck-shaped latching or locking mechanism 10, which ensures that the first engagement profile 8 of the mandrel 2 is axially fixedly connected to the adapter element 7 after being engaged into the mating engagement profile 9 by pressure application. The second engagement connection 11 thus established realizes the transmission of thrust and pull between the mandrel 2 and the adapter element 7. Unnecessarily, the second engagement connection 11 is formed torsionally around the longitudinal axis of the mandrel.

[0029] The latching / locking mechanism 10 is further constructed such that an engagement force requiring a defined pressure must be overcome in order to transfer the first engagement profile 8 into the mating engagement profile 9. The engagement process proceeds rapidly, i.e., the head-shaped first engagement profile 8 fully impacts the concave groove of the mating engagement profile 9, thereby producing a latching or locking sound perceptible to the surgeon. This latching or locking sound serves as confirmation or control of the complete and reliable establishment of the second engagement connection 11.

[0030] The adapter element 7, preferably formed from a cylindrical substrate, also has a second engagement profile 12, which individually matches a plug portion 13, which is connected to a flexible connecting line 14 at its end. Figure 3 The plug portion 13 shown and disposed on the flexible connecting wire 14 provides a plug body 15 and two electrical contacts 16 extending from the plug body. Corresponding to the geometry of the plug portion 13, the second engagement profile 12 introduced on the adapter element 7 has corresponding grooves for the plug body 15 and for the two contacts 16.

[0031] Two grippers 17 mounted on the adapter element 7 hold the plug portion 13 in a spatially fixed position relative to the adapter element 7. In this case, a minimum engagement pressure also needs to be overcome, which results in... Figure 3 The third engagement connection 18 shown produces a click or locking sound that is audible to the surgeon. It also provides the surgeon with a reliable indication that the plug portion 13 engages accurately and reliably with the adapter portion 7.

[0032] The first and second engagement connections 11 and 18 are designed in the form of a locking or snap-fit ​​connection to enable a simple and quick operation for the corresponding physician, which in turn produces an audible sound.

[0033] exist Figure 4 The diagram illustrates the state of the medical device, wherein an adapter element 7 is engaged on the distal end of the core needle region, and a plug portion 13 is engaged within the adapter element (not shown). The core needle 2 is pulled proximally through the tube 1 relative to the tube 1, which is held in place, thereby pulling the elastic connecting wire 14, which is connected to the plug portion 13, proximally through the tube 1. Once the adapter element 7 extends from the proximal end of the tube 1, the plug portion 13 is easily released from the adapter element 7 and engaged into a socket preferably disposed on the IPG.

[0034] List of reference numerals

[0035] 1 tube

[0036] 2. Core needle

[0037] 3. Handle, the proximal end of the needle.

[0038] 4 Mechanical stop

[0039] 5. Tip of the core needle

[0040] 6 First joint connection

[0041] 7. Adapter Components

[0042] 8 First joint profile

[0043] 9. Pairing and Joining Profile

[0044] 10. Hook and latch mechanism

[0045] 11 Second joint connection

[0046] 12 Second joint profile

[0047] 13. Plug section

[0048] 14 Flexible connecting wires

[0049] 15. Plug body

[0050] 16 styluses

[0051] 17 Grippers

[0052] 18. Third joint connection.

Claims

1. A medical manipulation kit for connecting two spatially separated implants via a flexible connecting line (14), along which a mechanical interface of a plug-and-socket connection type is provided, the medical manipulation kit having: - A tube (1) and a core needle (2) guided inside the tube, the core needle having a core needle tip (5) releasably and securely positioned on a distal core needle region via a first engagement connection (6), the core needle tip protruding from the distal end of the tube in the engaged state. - A first engagement profile (8) is placed on the distal end of the core needle region, the first engagement profile being a portion of the second engagement connection (11), and - An adapter element (7) having a mating engagement profile (9) configured in reverse with the first engagement profile (8) for forming the second engagement connection (11), and the adapter element having a second engagement profile (12) configured in reverse with the plug portion or socket portion of the mechanical interface, the second engagement profile being part of the third engagement connection (18).

2. The operating kit according to claim 1, characterized in that, The first engagement connection (6) is formed in the form of a threaded-reverse thread connection or a bayonet connection.

3. The operating kit according to claim 1 or 2, characterized in that, The second engagement connection (11) and the third engagement connection (18) are based on a latch mechanism and / or a locking mechanism, which produce an audible sound when the latch mechanism and / or locking mechanism are engaged.

4. The operating kit according to claim 1 or 2, characterized in that, The first engagement profile (8) is head-shaped, and the mating engagement profile is concave, such that the first engagement profile (8) can engage with the concave mating engagement profile (9) in a pressure-supported manner through an audibly perceptible fastening process, or vice versa.

5. The operating kit according to claim 1 or 2, characterized in that, The flexible connecting wire (14) has at least one wire end with a mating profile configured as a plug portion or a socket portion, and The engagement profile configured as a plug portion or a socket portion can engage with the second engagement profile (12) in the case of forming the third engagement connection (18) in a position that does not change spatially relative to the adapter element (7).

6. The operating kit according to claim 1 or 2, characterized in that, The adapter element (7) and the flexible connecting line (14) are configured such that the engagement profile of the plug or socket portion has a maximum cross-sectional diameter in the engagement state, which is smaller than the cross-section of the tube (1) so that the adapter element (7) can be axially and completely placed inside the tube (1) while forming the second engagement connection (11) and the third engagement connection (18).

7. The operating kit according to claim 1 or 2, characterized in that, The adapter element (7) is constructed in the form of a cylinder having a cylindrical axis and two opposing cylindrical end regions along the cylindrical axis, with the mating engagement profile (9) and the second engagement profile (12) of the adapter element (7) respectively disposed on the opposing cylindrical end regions.

8. The operating kit according to claim 1 or 2, characterized in that, The second engagement profile (12) has at least two jaws (17) that, in the state of the third engagement connection (18), are in form-fitting and / or force-fitting contact with the outer profile of the plug portion or socket portion.

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