Electronic implant for implantation into a body

Abstract

The invention relates to an electronic implant (100a,b) for implantation into the body of a living being and for monitoring and / or stimulating a bodily function, in particular a pacemaker for monitoring and / or stimulating the human heart, wherein the implant comprises: a housing (1a) which accommodates (i) electronics connected to an electrode (3a) configured to monitor bodily function via the electrode (3a) and / or to deliver a stimulation pulse to a body section (H), and (ii) a preferably rechargeable energy storage device (2a) for the long-term supply of electrical energy to the electronics; and an anchoring section (VA) for anchoring the electronic implant (100a,b) to the body section (H), wherein the anchoring section (VA) comprises an anchor (VA1) which is screwed into the body section (H) by a rotational movement, and a rotation lock which preferably extends in the direction of a rotational axis (RA) corresponding to the rotational movement and prevents a rotational movement of the anchor (VA1) in the opposite direction to the rotational movement after the anchor (VA1) has been screwed in.

Description

[0001] The present invention relates to an electronic implant for implantation into a body, in particular an electronic pacemaker for monitoring and / or stimulating the human heart.

[0002] Implants with spiral anchorages and a rotating anti-rotation device are known from the prior art. With these implants, there is a risk that the wounds created by the incisions will either not heal at all or at least delay ingrowth for several weeks. Consequently, there is a risk that the implants will become detached before they have fully integrated. Further prior art documents are EP 2 181 656 A1 and WO 2019 / 090 256 A1.

[0003] Against this background, the purpose of the invention is to create an implant that ensures gentle, durable and improved fixation and drastically increases reliability.

[0004] This problem is solved with an implant according to claim 1. Preferred embodiments are the subject of the dependent claims.

[0005] An electronic implant according to the invention for implantation into the body of a living being and for monitoring and / or stimulating a bodily function, in particular a pacemaker for monitoring and / or stimulating the human heart, has the following features: a housing that accommodates (i) electronics connected to an electrode, configured to monitor bodily function via the electrode and / or to deliver a stimulation pulse to a body part, and (ii) an energy storage device, preferably rechargeable, for the long-term supply of electrical energy to the electronics; and an anchoring section for anchoring the electronic implant to the body section, wherein the anchoring section comprises: a first anchoring point, which is screwed into the body section by a rotational movement as intended, and a second anchoring point and / or anti-rotation device, which is realized by at least one linearly guided pin.

[0006] The implant is preferably implanted entirely into a human body. The implant is, for example, an organ pacemaker or an analysis unit. The latter analysis unit is designed, for example, to continuously or at specific intervals determine parameters such as blood pressure and / or blood values. Particularly preferably, the implant is a cardiac pacemaker or part of a cardiac pacemaker network, which can monitor and, if necessary, correct and, in an emergency, replace the body's own voltage impulse that stimulates the heart.

[0007] The energy storage device is primarily a rechargeable battery and has such a capacity that it can supply the implant with energy for, for example, 0.5 to 2.5 years before it needs to be recharged.

[0008] The implant can be designed specifically for recharging as described in WO 2024 / 165 186 A1 or WO 2024 / 165 185 A1 and may have the energy receiving section described therein.

[0009] The second anchorage and / or anti-rotation device ensures that the opposing rotational movement of the first anchorage, which would lead to loosening of the implant, is blocked. A rotational plane corresponding to the rotational movement preferably runs perpendicular to the axis of rotation.

[0010] The design of the second anchorage and / or anti-rotation feature as a linearly guided pin ensures that, during implant fixation, only a point load is applied, i.e., a point penetration by the pin occurs, thus preventing tearing or cutting into the tissue. This point load or penetration promotes rapid healing and consequently gentle implantation.

[0011] The first anchor is a spiral that is twisted into the body section by the rotational movement in the direction of the corresponding axis of rotation.

[0012] The at least one pin is, for example, needle-shaped and is pressed / pierced into the tissue of the body segment in such a way that it penetrates the tissue. The at least one pin can be straight and, after insertion, form at least the anti-rotation feature for the first anchorage. Preferably, the at least one straight pin can also be perforated so that the tissue grows into the perforation and the pin, despite its straightness, forms the second anchorage after the tissue has grown in.

[0013] Preferably, the electronic implant is designed such that the at least one preferably pre-tensioned pin is arc-shaped and preferably circular, and extends in an arc-shaped and preferably circular manner after anchoring the electronic implant in the body section or tissue, thus preventing the at least one pin from being pulled out.

[0014] The second anchor point, by virtue of its shape, generally forms an additional, fully functional anchor point and provides anti-rotation protection. In this design, too, the arc-shaped, preferably circular, pin can be perforated.

[0015] In particular, the shape of at least one pin creates an undercut that provides a secure anchor for the implant and also prevents rotation. Furthermore, the shape prevents the pin from unintentionally coming loose.

[0016] Preferably, the second anchoring and / or anti-rotation device includes a plurality of pins, each of which extends into the body section and prevents the rotational movement of the anchoring device in the opposite direction to the rotational movement.

[0017] Preferably, two, three, four or more pins are provided. Preferably, each pin exerts the aforementioned point load when securing the implant by penetrating the tissue.

[0018] The electronic implant is constructed, whereby the anchoring section has a mounting flange which is linearly displaceable on the housing, and the at least one pin or the plurality of pins is attached to the mounting flange, and The mounting flange is linearly offset after the spiral is screwed in, as intended, so that the pin or the multitude of pins penetrate or pierce the body section.

[0019] Preferably, the anchoring section has a locking flange provided on the housing or spiral, which guides the at least one pin or the plurality of pins under preload when the retaining flange is moved and preferably locks it in an end position.

[0020] For example, the locking flange includes openings that the pins pass through and guide when the mounting flange is moved.

[0021] Additionally, rough sections and / or protrusions, which press against the body section after the first anchor is screwed in and further prevent the opposite rotational movement of the first anchor through form and / or frictional engagement, may be formed on the locking flange or on a housing surface of the housing that rests against the tissue.

[0022] The pre-tensioned, linear guidance through the locking flange results in, or preferably occurs in such a way that the pre-tensioned pin or the plurality of pre-tensioned pins begins to bend radially outwards or inwards to the axis of rotation after / upon penetration into the body section.

[0023] This allows the undercut(s) to be formed well and reliably.

[0024] Preferably, the locking flange rests against the body section as intended after the spiral has been screwed in.

[0025] Preferably, the electronic implant has a structure whereby The mounting flange and / or the locking flange, as intended, after the spiral has been screwed in and the mounting flange has been moved, rests against the body section in such a way that it preferably grows into the body section.

[0026] The spiral is preferably used as an electrode for monitoring bodily functions and / or for delivering the stimulation impulse.

[0027] The electronic implant described above has the anchoring section, which has on the one hand the first anchoring and on the other hand the second anchoring and / or anti-rotation device, which is constructed by the at least one linearly guided pin.

[0028] Insofar as the linearly guided pin forms the second anchorage, the implant has an anchorage that is redundant to the first anchorage.

[0029] Preferred embodiments of the electronic implant according to the invention are explained below with reference to the accompanying figures. Fig. Figures 1A to 1C show the essential steps for attaching a variant of an electronic implant according to the invention to or in the human heart, wherein a locking flange is formed at one end of a housing and rests against the human heart, and a mounting flange is movably mounted on the housing; Fig. Figures 2A to 2C show the essential steps for attaching a further variant of an electronic implant according to the invention to the human heart, wherein the variant shown differs from the one in Fig. Variant 1A to 1C shown differs in that the locking flange is attached to a spiral of the implant; and Fig. 3 and Fig. Figure 4 shows preferred fixation catheters for implantation of the implant variants.

[0030] With reference to Fig. Sections 1A to 1C describe a variant of an electronic implant 100a according to the invention and the corresponding attachment steps for attaching the electronic implant 100a to the human heart.

[0031] The implant 100a is particularly preferred as a pacemaker or pacemaker network that is located in or on the human heart, or is to be implanted in these positions.

[0032] Fig. Figures 1A to 1C schematically show the inner wall of the heart H (body section), where the inner wall of the heart H can be that of the ventricle or the atrium - depending on the indication of the heart condition.

[0033] The implant 100a preferably has a housing 1a that accommodates all elements of the implant 100a and is preferably hermetically encapsulated. The housing 1a is, for example, made of titanium or glass and has a volume of at most 4 cm³. 3 , preferably less than or equal to 0.5 cm 3 , 1.0 cm3 , 1.5 cm 3 or less than or equal to 2 cm 3 The housing, for example, has a cylindrical shape with a length of less than or equal to 25 mm and a diameter of 7 mm.

[0034] The weight of the implant 100a is between 0.5 g and 4.0 g and preferably between 0.5 g and 1.5 g or 0.5 g and 2.5 g (grams).

[0035] The housing 1a contains an energy storage device 2a and electronics (not shown).

[0036] The energy storage device 2a is, for example, a battery or a rechargeable accumulator. The latter is particularly preferred, and may be, for example, an electrochemical accumulator or a solid-state accumulator. The energy storage device 2a serves, in particular, to provide the implant 100a with electrical energy over the long term. If the energy storage device 2a is a rechargeable accumulator, it is preferably dimensioned such that it supplies the implant 100a with electrical energy for, for example, one or two years before it needs to be recharged.

[0037] The electronics housed in the casing 1a are configured to monitor and / or stimulate a bodily function, in particular the heartbeat, via an electrode 3a projecting from the casing 1a. The electrode 3a penetrates the casing 1a and is in contact with the electronics within the casing 1a, enabling the electronics to monitor or deliver the stimulation pulse.

[0038] The electronics are preferably designed and programmed in such a way that the pacemaker fulfills an NGB code.

[0039] The implant 100a includes an anchoring section VA facing the inner wall of the heart for anchoring the electronic implant 100a to the body section or the inner wall of the heart H.

[0040] The anchoring section VA includes a first anchoring VA1 in the form of a spiral, which in the shown variant of the implant 100a preferably simultaneously forms the electrode 3a.

[0041] Furthermore, the anchoring section VA includes an additional fully functional second anchorage, which in particular forms or implements a rotation lock VA2 for the first anchorage VA1. In the illustrated variant of the implant 100a, the second anchorage VA2 is constructed from a plurality of pins. For example, two or three pins are provided, although the invention is not limited to this.

[0042] The pins VA2 are preferably pre-tensioned and attached to a mounting flange VA3, the mounting flange surrounding the housing 1a. For example, in the illustrated embodiment of the implant, two or three pins VA2 are attached to the mounting flange VA3. The invention is not limited to this number.

[0043] Each of the VA2 pens has a diameter (perpendicular to the drawing plane) that is much smaller than the diameter of the housing 1a, and is therefore designed to be needle-like.

[0044] The mounting flange VA3 has - in a direction perpendicular to the drawing plane of the Fig. 1A to 1C running section plane - an inner contour adapted to the outer surface of the housing 1a, so that the mounting flange VA3 is mounted to be linearly displaceable along the housing 1a.

[0045] A locking flange VA4a is formed on the housing 1a and has openings into which the pins VA2 are inserted. The locking flange VA4a and the openings formed therein serve to guide the pins VA2 when the mounting flange VA3 is moved.

[0046] The following explains the steps for securing the 100a implant.

[0047] The 100a implant is preferably inserted into the heart, particularly the atrium or ventricle, via a blood vessel.

[0048] There, a first fastening step takes place in which the spiral VA1, which forms the first anchor, is screwed into the inner wall H of the heart and the corresponding tissue by a rotational movement.

[0049] This insertion is achieved by bringing the implant 100a so close to the inner wall of the heart H that the spiral VA1 penetrates the corresponding tissue and then the housing 1a is rotated around the in Fig. The rotation is performed around the axis of rotation RA shown in Figure 1B. The rotational movement leads to a screwing in of the spiral VA1. A plane of rotation preferably runs perpendicular to the axis of rotation.

[0050] The screwing process continues until the locking flange VA4a rests against the inner wall of the heart H. Fig. 1A shows the corresponding state achieved by implant 100a.

[0051] The fastening then goes to the in Fig. Step 1B shown. If the fastening were left as shown in Fig. In the condition shown in Figure 1A, there would be a risk that the implant 100a could become dislodged again due to a rotational movement opposite to the described rotational movement caused by the heart's movements. For this reason, a second, fully functional anchoring mechanism, providing protection against pulling out and rotation, is provided, which includes the pins forming the second anchoring and anti-rotation device VA2.

[0052] According to Fig. In step 1B, a force is applied to the mounting flange VA3, causing it to move linearly towards the inner wall of the heart H. The ends of the pins VA2 facing the inner wall H gently puncture the tissue at a single point and, due to the movement of the mounting flange VA3, penetrate the inner wall H or the tissue, or the pins VA2 are driven into the tissue.

[0053] The openings formed in the locking flange VA4a guide the pins VA2 in their preferably pre-tensioned state preferably in a circular motion during this movement.

[0054] The mounting flange VA3 is moved until it abuts and rests against the locking flange VA4a, preferably locking in the final position shown. The corresponding state is shown in Fig. 1C shown.

[0055] The mounting flange VA3 and the locking flange VA4a are located in the Fig. 1C preferentially attaches to the inner wall of the heart H in such a way that both grow into the tissue over time.

[0056] The pins VA2 driven into the inner wall H of the heart form the second anchorage and the anti-rotation device for the first anchorage by blocking a rotational movement of the housing 1a of the implant 100a in the opposite direction. This ensures that an (unintentional) detachment of the implant 100a from the inner wall H is no longer possible.

[0057] It should be emphasized that the pins VA2 are designed in such a curved, preferably circular, shape that when the mounting flange VA3 is moved, they do not penetrate / are driven straight into the tissue, but rather bend / extend radially outwards to the axis of rotation RA. This radially outward-extending curved shape can be achieved by the pre-tensioned guidance provided by the locking flange VA4a.

[0058] The arc-shaped design has the effect that the pins VA2 penetrate the tissue of the inner heart wall H at a point and undercut the penetrated tissue, so that the mounting flange VA3, after striking the locking flange VA4a, can no longer move in the opposite direction, thus forming the second fully functional anchor and the anti-rotation device for the first anchor.

[0059] This prevents the implant 100a from becoming unintentionally dislodged.

[0060] Fig. Figures 2A to 2C show another variant of the implant 100b according to the invention.

[0061] This variant 100b differs from the one from Fig. 1A to 1C differ only in that the locking flange VA4b is attached in a different location. The elements that are related to those from Fig. Items 1A to 1C, which are identical, bear the same reference numerals, with reference to the corresponding explanations. Fig. Reference is made to 1A to 1C.

[0062] The locking flange VA4b is not attached to the housing 1a, but directly to the spiral VA1 or the anchor VA1. The spiral VA1 passes through the locking flange VA4b and is embedded in the material of the locking flange VA4b, such that the spiral VA1 and the locking flange VA4b are firmly connected to each other.

[0063] The locking flange VA4b is attached to the coil VA1 in such a way that the housing 1a and the locking flange VA4b are at a specific distance from each other. As a result, after the coil VA1 is screwed in, the housing 1a does not rest against the inner wall H of the heart, but is spaced away from it. This condition results from Fig. 2A stands out.

[0064] The locking mechanism is set, or the insertion and driving in of the pin VA2 is carried out in Fig. 2B and is connected to the process from Fig. 1B identical. Different from Fig. 1B, however, is still that the relocation of the mounting flange VA3 results in the mounting flange being relocated beyond the housing 1a and, from a certain position, no longer resting on the housing 1a. Fig. 2C shows the state in which the mounting flange VA3 abuts the locking flange VA4b.

[0065] In this variant, the anchoring section VA ensures that the housing 1a, after complete fastening, lies at a specific distance from the inner wall H of the heart and that the flanges are completely embedded (see Fig. 2C).

[0066] This distance allows, for example, the implant 100b to be removed again in the event of malfunctions by cutting the spiral VA1 between housing 1a and preferably ingrown mounting flange VA4b.

[0067] The implant 100a, 100b is preferably fixed using a fixation catheter as described in Fig. 3 is shown.

[0068] The in Fig. The 3 shown fixation catheter has a receiving section K1, which defines a receiving space K2, into which the implant 100a,b is inserted, so that the spiral VA1 protrudes at one end of the receiving space K2.

[0069] A coupling guide K3 is connected to one end of the housing 1a and enables the housing 1a to perform the rotational movement necessary for fastening and subsequently a linear displacement.

[0070] The fixation catheter is inserted through the vessel into the corresponding heart chamber, the spiral VA1 is guided to the body section formed by the inner wall of the heart, and a protective cylinder (not shown) is withdrawn.

[0071] In this position, the flexible, movable axis K3 is rotated so that the spiral twists into the inner wall of the heart or the tissue.

[0072] The mounting aid is then offset linearly to the housing 1a, which results in the mounting flange being offset and the pins being inserted into the fabric, as shown below. Fig. Described in sections 1A to 1C, they will be driven in.

[0073] Ultimately, coupling K4 will be released and the fixation catheter removed.

[0074] The implant 100a,b sits securely on the inner wall of the heart H.

[0075] Fig. Figure 4 shows a further variant of the implant 100c according to the invention and a corresponding attachment catheter for implanting the implant 100c.

[0076] This variant 100c differs from the one from Fig. 1A to 1C by the fact that the locking flange VA4c is constructed slightly differently, the housing 1c is cylindrical, a pole 21c of the energy storage device 2a protrudes on the rear end face of the housing 1c and projections 4c, 5c are formed on both end faces.

[0077] The elements that are related to those from Fig. Items 1A to 1C, which are identical, bear the same reference numerals, with reference to the corresponding explanations. Fig. Reference is made to sections 1A to 1C. Regarding volume and weight, please also refer to the explanations in section 1A. Fig. Refer to 1A to 1C.

[0078] The Fig. Figure 4 shows a longitudinal section of the 100c implant.

[0079] The locking flange VA4c is arranged such that, as also referred to in the Fig. Described in sections 1A to 1C, after the spiral VA1 is screwed in, it lies against the inner wall of the heart. It differs from the one described in Fig. Figures 1A to 1C show that this is achieved essentially by forming a detent notch VA41c on a circumferential surface of the locking flange VA4c that points radially outwards towards the axis of rotation RA. This detent notch VA41c serves to support a protective cylinder of the Fig. 4 shown fixation catheters, which is described further below.

[0080] The projections 5c, which are located on the rear end face of the cylindrical housing 1c, serve to interlock with the fixing catheter, which will be explained below.

[0081] The pole 21c of the energy storage device 2a, which protrudes on the rear end face, also interacts with the attachment catheter by virtue of its arrangement, by being inserted into a coupling guide K3c, which is also described below.

[0082] The in Fig. The 4 shown fixation catheter has a receiving section K1c, which defines a receiving space K2c, into which the implant 100c is inserted, so that the spiral VA1 protrudes at one end of the receiving space K2c.

[0083] The protective cylinder K5c is mounted on the outside of the receiving section K1c and can be moved in the direction of the rotation axis RA. In the Fig. In the position shown in Figure 4, a nose formed on an inside of the protective cylinder K5c engages in the detent notch VA41c and holds the protective cylinder K5c in the position shown, with the protective cylinder K5c covering the spiral VA1.

[0084] The coupling guide K3c has two coupling sections K31c, which extend section by section circumferentially around the axis of rotation RA. These coupling sections K31c are inserted as intended into openings formed in the rear end face of the housing 1c and are thus located in a coupling space 7c of the implant.

[0085] By subsequent rotation, the implant 100c and the coupling guide K3c are connected to each other in a bayonet-like manner. Simultaneously with the insertion of the coupling sections K31c as described above, the pole 21c is inserted into a corresponding pole receiving chamber K32c.

[0086] The fixation catheter, along with the 100c implant, is then inserted through the vessel into the corresponding heart chamber. The protective cylinder K5c covers the VA1 coil during this procedure, protecting the vessel or heart from accidental injury by the VA1 coil.

[0087] Once the desired heart chamber is reached, the implant 100c is advanced to the body segment (heart chamber site) formed by the inner wall of the heart, and the protective cylinder K5c is retracted. This retraction is achieved by shifting the receiving section K1c relative to the implant 100c or the coupling guide K3c, thereby moving the protective cylinder back in the direction of arrow P1. The protective cylinder K5c is retracted until a front edge K51c of the protective cylinder engages in the locking notch VA41c.

[0088] To anchor the coil VA1, the coupling guide K3c is then rotated, whereby the coupling sections K31c located in the coupling space 7c rotate equally and thus set the implant 100c into rotation. The rotation of the implant 100c leads to the coil VA1 being screwed into the tissue of the inner heart wall.

[0089] Subsequently, the recording section K1c is linearly offset relative to the housing 1c by moving the coupling guide K3c into Fig. 4 is pulled back to the left, which causes the mounting flange VA3 to be offset and the pins to enter the fabric, as shown below. Fig. The coupling guide is retracted until the projections 5c engage in corresponding recesses K11c formed in the receiving section K1c.

[0090] Finally, the coupling is released and the fixation catheter removed by rotating the coupling guide K3c and pulling the coupling sections K31c out of the coupling space 7c, which detaches the fixation catheter from the implant 100c. The projections 5c and the recesses K11c prevent the implant 100c from rotating when the coupling guide K3c is rotated.

[0091] The electronics of the 100c implant are located, as in Fig.4 shown, on a circuit board. Instead of the circuit board shown, the corresponding components can also be embedded in a randomly wired configuration, preferably in the form of a solid cylinder that fits into the housing.

[0092] In the described variants of implant 100a, 100b and 100c, the implant has a second anchorage VA2 that is redundant to the first anchorage VA1.

[0093] The statements preceding the character description apply equally to the descriptions and vice versa.

Claims

[1] Electronic implant (100a,b) for implantation into the body of a living being and for monitoring and / or stimulating a bodily function, in particular a pacemaker for monitoring and / or stimulating the human heart, wherein the implant comprises: a housing (1a) which accommodates (i) electronics connected to an electrode (3a) configured to monitor bodily function via the electrode (3a) and / or to deliver a stimulation pulse to a body section (H), and (ii) a preferably rechargeable energy storage device (2a) for the long-term supply of electrical energy to the electronics; and an anchoring section (VA) for anchoring the electronic implant (100a,b) to the body section (H), wherein the anchoring section (VA) has: a first anchorage (VA1) which is screwed into the body section (H) by a rotational movement as intended, and a second anchorage and / or anti-rotation device which is realized by at least one linearly guided pin, wherein the first anchorage (VA1) is a spiral which is screwed into the body section (H) by the rotational movement in the direction of the corresponding axis of rotation, and wherein a mounting flange (VA3) is linearly displaceable on the housing (1a), and at least one pin (VA2) or the plurality of pins (VA2) is attached to the mounting flange (VA3), and The mounting flange (VA3) is linearly displaced as intended after the spiral (VA1) is screwed in, such that the pin (VA2) or the plurality of pins (VA2) penetrate into the body section (H). [2] Electronic implant (100a,b) according to claim 1, wherein the at least one pin (VA2) is arc-shaped and pre-tensioned and extends in an arc-shaped manner into the body section (H) after anchoring of the electronic implant (100a,b) and thus also prevents the at least one pin (VA2) from being pulled out. [3] Electronic implant (100a,b) according to claim 1 or 2, wherein a plurality of pins (VA2) are provided and each of the pins (VA2) extends into the body section (H) and prevents the rotational movement of the first anchoring opposite to the rotational movement and the withdrawal. [4] Electronic implant (100a,b) according to claim 1, 2 or 3, wherein a locking flange (VA4a,b) is provided on the housing or the coil (VA1) which guides the at least one pin (VA2) or the plurality of pins (VA2) under bias during linear displacement of the mounting flange (VA3) and preferably locks it in the end position. [5] Electronic implant (100a,b) according to claim 4, wherein the pre-tensioned linear guidance by the locking flange (VA4a,b) is carried out or results in the pre-tensioned pin (VA2) or the plurality of pre-tensioned pins (VA2) beginning to bend radially outwards or inwards to the axis of rotation (RA) after / upon penetration into the body section (H). [6] Electronic implant (100a,b) according to claim 4 or 5, wherein the locking flange (VA4a,b) is intended to rest against the body section (H) after the spiral (VA1) has been screwed in. [7] Electronic implant (100a,b) according to claim 6, wherein the mounting flange (VA3) and the locking flange (VA4a,b) are in contact with the body section (H) as intended after the spiral (VA1) has been screwed in and the mounting flange (VA3) has been moved. [8] Electronic implant (100a,b) according to claim 6 or 7, wherein the mounting flange (VA3) and / or the locking flange (VA4a,b) is designed to be positioned against the body section (H) after the spiral (VA1) has been screwed in, such that it grows into the body section (H). [9] Electronic implant (100a,b) according to any one of claims 1 to 8, wherein the coil (VA1) serves as an electrode for monitoring bodily function and / or for delivering the stimulation pulse.

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