Tearable trocar and implantation system

Abstract

The utility model discloses a tearable trocar and an implantation system, and belongs to the technical field of medical instruments. The trocar is used for allowing an electrode wire to penetrate through, the trocar is provided with a first end and a second end, the electrode wire penetrates into the trocar from the first end and penetrates out of the trocar from the second end, the trocar comprises a main body and a separation belt which are arranged in the circumferential direction, a tearing line is arranged at the joint of the main body and the separation belt, and the separation belt can be torn off from the main body so that a notch can be formed in the main body; and the notch is communicated with the outside at the first end. According to the tearable trocar and the implanting system, the implanting of a single electrode lead and a plurality of branched electrode leads can be met, and the trocar is convenient to withdraw.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a tearable cannula and implantation system. Background Technology

[0002] Currently, for motor disorders such as Parkinson's disease, epilepsy, dystonia, and spinal cord pain, or mental illnesses such as depression, alcoholism, and obsessive-compulsive disorder, when the effectiveness of drug treatment declines, deep brain stimulation (DBS) or a combination of spinal cord stimulation can be used to improve treatment outcomes. Taking DBS as an example, when implanting electrode leads, a head frame and a cannula are required. The head frame is used to hold the skull and electrode leads in place, while the cannula is inserted into the body to create an implantation channel for the electrode leads.

[0003] In related technologies, when electrode leads are implanted into the body, the cannula is made of stainless steel and is only suitable for implanting a single electrode lead. However, when multiple branched electrode leads are implanted, the aforementioned cannula is insufficient to meet the requirements. Furthermore, since one end of the electrode lead is implanted in the body and the other end is fixed to the head frame, sufficient space outside the skull is required for cannula withdrawal. However, with product miniaturization, the distance available for cannula withdrawal is becoming increasingly smaller, leading to difficulties in cannula withdrawal. Utility Model Content

[0004] The purpose of this invention is to provide a tearable cannula and implantation system that can accommodate the implantation of single electrode leads and multiple branched electrode leads, and the cannula is easy to remove.

[0005] To achieve this objective, the present invention adopts the following technical solution:

[0006] A tearable cannula needle for passing through an electrode wire, the cannula needle having a first end and a second end, the electrode wire being inserted from the first end and exiting from the second end, the cannula needle comprising a circumferentially arranged body and a separating band, a tear line being provided at the connection between the two, the separating band being capable of tearing open from the body to form a notch in the body, and the notch communicating with the outside at the first end.

[0007] In some possible implementations, the tear strength of the material of the separator is less than the tear strength of the material of the body.

[0008] In some possible implementations, the cannula includes at least one of the separation bands disposed circumferentially.

[0009] In some possible implementations, the cannula is provided with at least two separation bands circumferentially, the at least two separation bands are arranged consecutively, and the materials of adjacent separation bands have different tear strengths.

[0010] In some possible implementations, the separating strip includes a plurality of separating blocks arranged axially, with adjacent separating blocks capable of tearing apart each other.

[0011] In some possible implementations, the separator and the body are bonded together by adhesive bonding, or the separator and the body are snap-fitted together.

[0012] In some possible implementations, the separator extends to the second end, or the separator extends to the middle of the cannula.

[0013] In some possible implementations, the separating strip is straight or spiral.

[0014] In some possible implementations, both the separator and the body have a gripping structure at the first end.

[0015] An implantation system comprising a tearable cannula as described in any of the preceding claims.

[0016] The beneficial effects of this utility model are:

[0017] This invention provides a tearable cannula needle. The second end of the cannula needle maintains a complete circular cross-section when implanted into the body. When the implanted electrode wire is a single wire, it simply passes through the cannula needle. When the implanted electrode wire is a multi-branched type, the separator is torn from the main body starting from the first end of the cannula needle, forming a notch in the main body. This avoids space constraints and ensures sufficient circumferential space for the electrode wire to pass through, facilitating the passage of the multiple branched portions of the electrode wire. Therefore, the cannula needle is compatible with both conventional single electrode wires and complex multi-branched electrode wires, thus meeting various application requirements. Because a tear line is provided between the main body and the separator, the separator is easily torn from the main body. The main body provides a compressive strength, preventing deformation and ensuring that the electrode wire is not deformed or damaged, thus not affecting its use and ensuring high reliability.

[0018] The present invention provides an implantation system including the aforementioned tearable cannula. Since one end of the electrode lead is implanted in the body and the other end is fixed on the micro-push system, when the cannula is withdrawn, the tearing of the separating strip facilitates the separation of the cannula from the electrode lead at the notch. That is, only a small distance is needed between the human body and the end of the micro-push system near the human body to achieve cannula withdrawal, shortening the withdrawal distance of the cannula and facilitating cannula withdrawal while meeting the miniaturization design requirements of the product. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the implantation system provided in Embodiment 1 of this utility model;

[0020] Figure 2 yes Figure 1 Enlarged view at point X;

[0021] Figure 3 This is a schematic diagram of the tearable cannula provided in Embodiment 1 of this utility model;

[0022] Figure 4 yes Figure 3 Enlarged view of point Y;

[0023] Figure 5 This is a schematic diagram of the tearable cannula provided in Embodiment 2 of this utility model;

[0024] Figure 6 This is a schematic diagram of the tearable cannula provided in Embodiment 3 of this utility model.

[0025] In the picture:

[0026] 1. Cannula; 11. Main body; 111. First locking protrusion; 112. Second locking groove; 12. Separator; 121. Separator block; 122. First locking groove; 123. Second locking protrusion; 13. Grip structure; 1A. First end; 1B. Second end; 2. Head frame; 3. Arc bow; 4. Micro-push system; 5. Electrode lead wire. Detailed Implementation

[0027] To make the technical problems solved by this utility model, the technical solutions adopted, and the technical effects achieved clearer, the technical solutions of the embodiments of this utility model will be further described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0028] In the description of this utility model, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0029] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0030] The technical field and related terms of the embodiments of this application are briefly described below.

[0031] Implantable medical systems include implantable neurostimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead transfer systems. Examples of implantable neurostimulation systems include deep brain stimulation (DBS), cortical nerve stimulation (CNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), and vagus nerve stimulation (VNS).

[0032] Implantable neurostimulation systems consist of a stimulator implanted in the patient's body (i.e., an implantable neurostimulator) and a programmed device placed outside the patient's body. In other words, the stimulator is a medical device, or medical devices include stimulators. Related neuromodulation techniques primarily involve stereotactic surgery to implant electrodes (e.g., electrode wires) at specific sites (target points) in the body's tissues. Discharge pulses are then delivered through these electrodes to the target points, modulating the electrical activity and function of corresponding neural structures and networks, thereby improving symptoms and alleviating pain.

[0033] As an example, a DBS includes an IPG (Implantable Pulse Generator), extension leads, and electrode leads. The IPG is connected to the electrode leads via the extension leads. The IPG is implanted in the patient's body, for example, in the chest or other internal locations.

[0034] As another example, DBS includes an IPG and electrode leads, with the IPG directly connected to the electrode leads. The IPG is implanted in the patient's head, for example, by creating a groove in the patient's skull and then placing the IPG in the groove. In this case, the IPG may not protrude from the outer surface of the skull, or it may protrude partially from the outer surface of the skull.

[0035] In this system, the IPG responds to programmed commands sent by a programmable device, relying on sealed batteries and circuits to provide controllable electrical stimulation therapy (or electrical stimulation energy) to tissues within the body. The IPG delivers one or more controllable specific electrical stimuli to specific areas of tissues within the body via electrode leads.

[0036] In some embodiments, the extension wire is used in conjunction with the IPG as a medium for transmitting electrical stimulation, thereby transmitting the electrical stimulation generated by the IPG to the electrode wire.

[0037] In some embodiments, electrical stimulation can be delivered in the form of a pulsed signal or a non-pulsed signal. For example, electrical stimulation can be delivered as a signal with various waveform shapes, frequencies, and amplitudes. Therefore, non-pulsed signal electrical stimulation can be a continuous signal, which can have a sinusoidal waveform or other continuous waveforms.

[0038] After receiving electrical stimulation from the IPG or extension leads, the electrode leads deliver the stimulation to specific areas of tissue within the body via multiple electrode contacts. The stimulator may have one or more electrode leads on one or both sides, with multiple electrode contacts on each lead. These contacts may be evenly or non-uniformly arranged circumferentially on the electrode leads. As an example, the electrode contacts may be arranged in a 4x3 array (a total of 12 contacts) circumferentially on the electrode leads. The electrode contacts may include stimulating electrode contacts and / or collecting electrode contacts. The electrode contacts may be in shapes such as sheet-like, ring-like, or dot-like.

[0039] In some embodiments, the stimulated tissue may be the patient's brain tissue, and the stimulated site may be a specific location within the brain tissue. Generally, the stimulated site differs depending on the patient's disease type, and the number of stimulation contacts (single-source or multi-source), the application of one or more specific electrical stimulation pathways (single-channel or multi-channel), and the stimulation parameters (values) also vary.

[0040] This application does not limit the applicable disease types, but can be any disease type applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation, gastric stimulation, peripheral nerve stimulation, or functional electrical stimulation. Among these, DBS can be used to treat or manage diseases including, but not limited to: spastic disorders (e.g., epilepsy), pain, migraines, mental illnesses (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorders, post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, mobility disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric diseases and impairments.

[0041] In this embodiment of the application, when the programmable device and the stimulator establish a programmable connection, the programmable device can be used to adjust one or more stimulation parameters of the stimulator (or one or more stimulation parameters of the pulse generator, with different stimulation parameters corresponding to different electrical stimuli). Alternatively, the stimulator can sense the patient's electrophysiological activity to collect electrophysiological signals, and the collected electrophysiological signals can be used to continue adjusting the stimulation parameters of the stimulator to achieve closed-loop control (or adaptive adjustment) of the stimulation parameters.

[0042] Stimulation parameters may include at least one of the following: electrode contact identification for delivering electrical stimulation (e.g., electrode contact #2 and electrode contact #3), frequency (e.g., the number of electrical stimulation pulse signals per second, in Hz), pulse width (duration of each pulse, in μs), amplitude (generally expressed as voltage, i.e., the intensity of each pulse, in V), timing (e.g., continuous or bursty, bursty refers to discontinuous timing behavior composed of multiple processes), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode, and cyclic stimulation mode), physician control upper and lower limits (the range that the physician can adjust), and patient control upper and lower limits (the range that the patient can adjust independently).

[0043] In some embodiments, the stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

[0044] Programmable devices can include physician-controlled devices (i.e., devices used by physicians) and / or patient-controlled devices (i.e., devices used by patients). Physician-controlled devices are, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software. Patient-controlled devices are, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software; patient-controlled devices can also be other electronic devices with programming functions (e.g., chargers with programming functions, electrophysiological acquisition devices, etc.).

[0045] Example 1

[0046] like Figures 1-4 As shown, an implantation system includes a tearable cannula for creating an implantation channel for an electrode lead 5. Further, the implantation system also includes a head frame 2, an arcuate bow 3, and a micro-pushing system 4. Taking a deep brain electrode implantation system as an example, the arcuate bow 3 is fixed to the skull via the head frame 2, providing fixation and support. The micro-pushing system 4 is fixed to the arcuate bow 3, enabling the electrode lead 5 to be precisely implanted into the target location within the brain. The arcuate bow 3, head frame 2, micro-pushing system 4, and electrode lead 5 are all based on existing technology and will not be described in detail further.

[0047] The electrode leads 5 come in two types: single and bifurcated. Both types have the same outer diameter at the implanted end. The bifurcated electrode leads 5 have at least two branches outside the body. Bifurcated electrode leads 5, such as detection or sensing electrode leads, offer better therapeutic effects.

[0048] To accommodate the two types of electrode leads 5 described above, this embodiment provides a tearable cannula. The cannula 1 is used for the electrode lead to pass through, and the cannula 1 has a first end 1A and a second end 1B. The electrode lead enters from the first end 1A and exits from the second end 1B. Exemplarily, the cannula 1 is a round tube, and the inner diameter of the cannula 1 is slightly larger than the outer diameter of the electrode lead 5. Under normal conditions, the cannula 1 only accommodates the implantation of a single electrode lead 5.

[0049] The cannula 1 includes a body 11 arranged circumferentially and a separating band 12. A tear line is provided at the connection between the two, and the separating band 12 can be torn from the body 11 to form a notch on the body 11. The notch communicates with the outside at a first end 1A. Exemplarily, the separating band 12 tears from the body 11 starting from the first end 1A. Optionally, the separating band 12 extends to the middle position of the cannula 1, so that the notch extends from the first end 1A to the middle position, such as extending to 1 / 3, 1 / 2, 2 / 3, etc. of the cannula 1, without limitation.

[0050] The second end 1B of the cannula 1 is implanted into the body with a complete circular cross-section. When the implanted electrode wire 5 is a single wire, it simply passes through the cannula 1. When the implanted electrode wire 5 is a multi-branched wire, the separator 12 is torn from the body 11 starting from the first end 1A of the cannula 1, forming a notch in the body 11 to avoid space constraints and ensure that the cannula 1 has sufficient circumferential space to allow the electrode wire 5 to pass through, facilitating the passage of the multi-branched portions of the electrode wire 5. Therefore, the cannula 1 is compatible with both conventional single electrode wires and complex multi-branched electrode wires, thus meeting usage requirements. Because a tear line is provided between the body 11 and the separator 12, the separator 12 is easily torn from the body 11, providing the body 11 with a compressive strength and preventing deformation. This ensures that the electrode wire 5 will not be deformed or damaged, does not affect its use, and has high reliability.

[0051] like Figure 1 As shown, when the cannula 1 is used in the above-mentioned implantation system, since one end of the electrode lead 5 is already implanted in the body and the other end is fixed on the micro-push system 4, the space between the skull and the micro-push system 4 is limited when the cannula 1 is withdrawn, sometimes making it difficult to withdraw the cannula 1 effectively. Therefore, by tearing the separator 12, it is easier to peel the cannula 1 off the electrode lead 5. Only a small distance is needed between the human body and the end of the micro-push system 4 closest to the human body to achieve the withdrawal of the cannula 1, shortening the withdrawal distance of the cannula 1, facilitating the withdrawal of the cannula 1, and meeting the miniaturization design requirements of the implantation system.

[0052] The tear strength of the material of the separator 12 is less than that of the material of the main body 11. Tear strength refers to a material's ability to resist tearing, usually expressed in units of force (such as N / mm). The magnitude of tear strength directly affects the durability and safety of the material. Materials with low tear strength may crack when subjected to a small external force, affecting service life and safety. Materials with high tear strength have better tear resistance and are less likely to crack when subjected to external force. Due to the difference in tear strength between the two materials, a tear line is formed between them at the joint. Furthermore, the main body 11 has better resistance to tearing than the separator 12. When it tears, only a small force is needed to tear the separator 12 at the joint, preventing the main body 11 from being torn when the separator 12 is torn.

[0053] Optionally, the material of the separator 12 can be a biocompatible material, such as Peek (Polyetheretherketone), Pebax (Polyether-block-amide), PTFE (Polytetrafluoroethylene), PC (Polycarbonate), PP (Polypropylene), TPU (Thermoplastic Polyurethane), etc.; the material of the main body 11 can be a biocompatible metallic material, such as 316LVM, Nitinol, etc.

[0054] The separator strip 12 and the main body 11 are bonded together with adhesive, or the separator strip 12 and the main body 11 are snapped together. One of the separator strip 12 and the other of the main body 11 has a slot, and the slot and the slot engage to achieve the snap-fit ​​connection between the separator strip 12 and the main body 11. For example, the first side of the separator strip 12 has multiple spaced-apart first slots 122, and the second side has multiple spaced-apart second slots 123. The side of the main body 11 corresponding to the first side has multiple spaced-apart first slots 111, and the side of the main body 11 corresponding to the second side has multiple spaced-apart second slots 112. The multiple first slots 122 and the multiple first slots 111 are snapped together one-to-one, and the multiple second slots 112 and the multiple second slots 123 are snapped together one-to-one.

[0055] Optionally, the divider 12 is straight, with a simple structure and easy manufacturing.

[0056] The cannula needle 1 includes at least one partition strip 12 arranged circumferentially. By increasing the number of partition strips 12, the formed gap can be increased accordingly, thereby accommodating larger electrode wires 5.

[0057] Both the separating strip 12 and the main body 11 are provided with a gripping structure 13 at the first end 1A. When tearing, both hands grip the two gripping structures 13 respectively, which facilitates the application of force when the separating strip 12 tears from the main body 11. The separating strip 12 and the gripping structure 13 connected thereto can be a single piece of structure, and the main body 11 and the gripping structure 13 connected thereto can also be a single piece of structure. The gripping structure 13 and the cannula 1 are set at an angle, such as 90°, to further facilitate the application of force.

[0058] Example 2

[0059] like Figure 5As shown, this embodiment provides a tearable cannula and an implantation system including the tearable cannula. Its structure is basically the same as that of Embodiment 1, and the identical parts will not be repeated. The difference lies in that: the cannula 1 has at least two circumferentially arranged separators 12, which are continuously arranged. The tear strength of adjacent separators 12 is different, allowing multiple separators 12 to be torn simultaneously, or one separator 12 to be torn from another, or specific separators 12 to be torn according to actual usage requirements. This ensures that the cannula 1 has sufficient circumferential space for the electrode wire 5 to pass through, and that the untorn separators 12 are not deformed by pressure. The separators 12 can be made of metal or non-metal materials, as described in Embodiment 1.

[0060] Optionally, the separating strip 12 includes a plurality of separating blocks 121 arranged along the axial direction. Adjacent separating blocks 121 can be torn apart from each other. Specifically, the separating blocks 121 can be torn apart according to the actual length. While ensuring sufficient space for the electrode wire 5 to pass through, as many separating blocks 121 as possible are retained to achieve the supporting and protective function for the electrode wire 5. The material of the separating blocks 121 can be metal or non-metal, as shown in Embodiment 1. The separating blocks 121 of the same separating strip 12 can be glued together or snap-fitted together, as shown in Embodiment 1.

[0061] Example 3

[0062] like Figure 6 As shown, this embodiment provides a tearable cannula and an implantation system including the tearable cannula. Its structure is basically the same as that of Embodiments 1 and 2. The same parts will not be described again. The difference is that the separator 12 extends to the second end 1B, so that the notch at the second end is also connected to the outside. That is, both ends of the cannula 1 in the length direction have notches that are connected to the outside. After the electrode wire 5 is implanted, the cannula 1 can be easily peeled off and removed from the electrode wire 5.

[0063] Example 4

[0064] This embodiment provides a tearable cannula and an implantation system including the tearable cannula. The structure is basically the same as that of Embodiment 1. The same parts will not be described again. The difference is that the separator is spiral-shaped, that is, a spiral strip is formed along the main body. After the separator is torn open, a spiral notch is formed on the main body.

[0065] Obviously, the above embodiments of this utility model are merely examples for clearly illustrating the present utility model, and are not intended to limit the implementation of the present utility model. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this utility model should be included within the protection scope of the claims of this utility model.

Claims

1. A tearable cannula needle, the cannula needle (1) being used for the passage of an electrode wire (5), characterized in that, The cannula (1) has a first end (1A) and a second end (1B). The electrode wire (5) is inserted from the first end (1A) and exits from the second end (1B). The cannula (1) includes a body (11) arranged circumferentially and a separating strip (12). A tear line is provided at the connection between the two. The separating strip (12) can be torn from the body (11) to form a notch on the body (11), and the notch communicates with the outside at the first end (1A).

2. The tearable cannula according to claim 1, characterized in that, The tear strength of the material of the separating strip (12) is less than that of the material of the main body (11).

3. The tearable cannula according to claim 1, characterized in that, The cannula (1) includes at least one of the separation strips (12) arranged circumferentially.

4. The tearable cannula according to claim 1, characterized in that, The cannula (1) is provided with at least two separation bands (12) along the circumferential direction. The at least two separation bands (12) are arranged continuously, and the tear strength of the materials of adjacent separation bands (12) is different.

5. The tearable cannula according to claim 1, characterized in that, The separating strip (12) includes a plurality of separating blocks (121) arranged along the axial direction, and adjacent separating blocks (121) can be torn apart from each other.

6. The tearable cannula according to claim 1, characterized in that, The separator (12) and the main body (11) are bonded together by adhesive, or the separator (12) and the main body (11) are snapped together.

7. The tearable cannula according to claim 1, characterized in that, The separator (12) extends to the second end (1B), or the separator (12) extends to the middle position of the cannula (1).

8. The tearable cannula according to claim 1, characterized in that, The separating band (12) is either straight or spiral.

9. The tearable cannula according to any one of claims 1-8, characterized in that, Both the separating strip (12) and the main body (11) are provided with a gripping structure (13) at the first end (1A).

10. An implantation system, characterized in that, Including the tearable cannula as described in any one of claims 1-9.

Images