Medical instrument for creating an opening in a vessel or organ wall

Abstract

A medical instrument for creating an opening in a vessel or organ wall is described, comprising a penetration body attached distally to a shaft arrangement having a longitudinal shaft axis, which has a first body section and a second body section adjoining the first body section proximally, the latter at least partially delimiting a cavity radially to the longitudinal shaft axis and having a cutting blade radially enclosing the cavity proximally. The invention is characterized in that the penetrating body comprises at least one first and one second penetrating body segment, each having a first and a second body section. The first body section of the first penetrating body segment terminates distally with a point, while the second section at least partially delimits a first cavity and has a cutting blade radially enclosing the first cavity. The first body section of the second penetrating body segment tapers distally in cross-section and has a recess distally facing the first penetrating body segment, into which the second body section of the first penetrating body segment can be partially inserted. Furthermore, the second body section partially delimits a second cavity and has a cutting blade radially enclosing the second cavity.

Description

Technical field

[0001] The invention relates to a medical instrument for producing an opening in a vessel or organ wall, comprising a penetration body attached distally to a shaft arrangement having a longitudinal shaft axis, the penetration body comprising a first body section and a second body section adjoining the first body section proximally, the latter having at least partially a cavity radially bounded to the longitudinal shaft axis and a cutting blade radially enclosing the cavity proximally.

[0002] Left ventricular assist devices (LVADs) are implanted in patients with end-stage heart failure, where the ejection of blood from the left ventricle into the systemic circulation is reduced. Conventional LVADs consist of an inflow cannula that directs blood from the left ventricle to the pump at the apex of the heart, and an outflow vascular graft that carries the blood to the aorta near the heart. To insert the inflow cannula into the left ventricle, it is necessary to create a hole in the apex of the heart (a procedure known as coring). State of the art

[0003] Various punching tools are available for creating or punching a hole within the myocardium at the left apex of the heart. One medically used punching tool from Abbott GmbH, marketed under the name "HeartMate 3 Coring Tool," features a hollow cylindrical cutting sleeve with a distally circumferential cutting blade. Inside this sleeve are a guide needle that extends distally beyond the cutting blade and is positioned centrally to the cutting sleeve, as well as a spiral that coaxially surrounds the guide needle and is located downstream of its tip. After suturing and fixing a retaining ring to the epicardium at the apex of the heart, the punching tool is guided through the circular opening of the retaining ring toward the heart wall. The guide needle serves to center and direct the further distal advancement of the punching tool.After the spiral makes contact with the epicardium, the punching tool and the spiral, which is connected to it in a rotationally fixed manner, are inserted into the myocardium under rotation and, with slight tension along the spiral, the cutting sleeve is screwed into the myocardium and through the endocardium.

[0004] However, a successful and complete transection of the three-layered heart wall (consisting of epicardium, myocardium and endocardium) only occurs if the cutting sleeve is completely inserted from the outside in through the heart wall and the wall is transected along the full circumference of the cutting blade.

[0005] Document US 2007 / 0167968 A1 describes a surgical instrument for creating a hole in a patient's body, which is capable of reducing the risk of incomplete transection of the heart wall. The instrument comprises a penetration body attached distally to a shaft assembly, which has a first body section that tapers conically distally and a second, hollow-cylindrical body section that adjoins the first body section proximally. The latter section at least partially defines a cavity radially to the longitudinal axis of the shaft and has a cutting blade proximally that radially surrounds the cavity.The conical tip of the first body section of the penetrating tool is inserted into the left ventricle through a preferably cruciate incision in the epicardium at the apex of the heart. The surrounding heart wall is temporarily displaced laterally towards the penetrating tool as it enters the left ventricle and returns to its original position after complete insertion against the shaft assembly. By withdrawing the penetrating tool, at the proximal end of which the cutting blade, which completely encloses the cavity radially, is attached, a cylinder of heart wall is punched out from the inside out and remains inside the penetrating tool. Although the known tool is capable of ensuring complete severing of the heart wall, a disadvantage lies in the fact that the preparatory incision of the epicardium and, in particular, the removal of the punching tool from the heart chamber or...The procedure can only be performed on the heart wall using a heart-lung machine (HLM) – on a bloodless and non-beating heart – as otherwise blood would flow uncontrollably from the left ventricle. A similar punching tool can be found in US 11,925,382 B2.

[0006] Another surgical punching tool is disclosed in US 2008 / 0009891 A1, the special feature of which is that a hollow cylinder serving as a punching tool with a distally circular cutting blade that cuts through the heart wall from the outside in, interacts with a protective counter-shield pre-positioned inside the left ventricle in such a way that immediately after the punch hole is introduced into the heart wall, the counter-shield is intended to seal the hole fluid-tight by completely surrounding the hole at the periphery against the inner heart wall.

[0007] One disadvantage of this medical procedure is that the insertion of the counter-shield into the left ventricle is performed via transaortic catheterization, which places an additional burden on the patient and can be associated with complications such as cardiac arrhythmias. Furthermore, the counter-shield must subsequently be very securely fixed to the inner wall of the heart to act as a counter-bearing for the punching tool and must also ensure that the hole in the heart wall is sealed against blood leakage in order to allow subsequent implantation of an LVAD without the use of cardiopulmonary bypass. Description of the invention

[0008] The invention is based on the objective of further developing a medical instrument for creating an opening in a vessel or organ wall, comprising a penetration body attached distally to a shaft arrangement having a longitudinal shaft axis, the penetration body having a first body section and a second body section adjoining the first body section proximally, the latter at least partially delimiting a cavity radially to the longitudinal shaft axis and having a cutting blade radially enclosing the cavity proximally, in such a way that, firstly, it should be ensured that the opening can be completely introduced into the vessel or organ wall in a predefinable shape and size, i.e. without any tissue portions otherwise protruding at the edge of the opening due to incomplete cutting, and secondly, it should be possible to create the opening in the vessel or organ wall, preferably in the region of the apex of the heart.Furthermore, the medical instrument should be suitable for creating an opening in the heart wall in conjunction with a sheath arrangement on the beating heart and without the need for heart-lung machine (HLM). The measures required for this should be limited solely to creating the opening itself, and no further procedures that burden the patient, such as inserting an auxiliary instrument into the vessel or organ, e.g., a counter-shield into the left ventricle, should be necessary.

[0009] The solution to the problem underlying the invention is specified in claims 1 and 2. Advantageously developing features of the invention are the subject of the dependent claims and the further description.

[0010] According to the solution, a first embodiment of a medical instrument for creating an opening in a vessel or organ wall, as defined in the preamble of claim 1, is characterized in that the penetrating body comprises at least one first and one second penetrating body segment, which are axially mounted one behind the other and separately from each other in a bidirectionally deflectable manner along the shaft arrangement, and each has a first body section that tapers distally in cross-section and a second body section. The first body section of the first penetrating body segment terminates distally, forming a point, and the second body section, which adjoins the first body section proximally, radially delimits at least partially a first cavity and has a cutting blade proximally surrounding the first cavity.The first body section of the second penetration body segment is shaped like a truncated cone and has a recess on its distal side oriented axially towards the first penetration body segment, into which the second body section of the first penetration body segment can be inserted at least partially, and the second body section adjoining the first body section of the second penetration body segment proximally limits a second cavity radially at least in some areas and has a cutting blade proximally surrounding the second cavity radially.

[0011] The underlying principle of the aforementioned medical instrument is to avoid initially weakening the vessel or organ wall by means of a preparatory, preferably cross-shaped, incision in the epicardium. This would otherwise necessitate immobilizing the heart using cardiopulmonary bypass and cardioplegia to prevent the risk of uncontrolled myocardial rupture. Instead, the instrument-based penetration of the vessel or organ wall should be safe and, in conjunction with a sheath arrangement, as fluid-tight as possible, i.e., without blood or fluid leakage from the vessel or organ wall upon severing, and without interrupting organ function or blood flow through the vessel.The medical instrument in question has a segmented penetration body, composed of at least two penetration body segments, each differing in its maximum outer diameter. This allows for the successive, stepwise creation of the opening or hole within the vessel or organ wall. The first penetration body segment, which has a distal tip and widens radially, preferably conically, proximally, is able to penetrate the vessel or organ wall from the outside, essentially without prior preparation of the outer wall, by advancing distally. During penetration of the vessel or organ wall by means of the first penetration body segment, the wall is displaced radially by the segment and slides along the outer contour of the first penetration body segment, remaining in close proximity to it.The shape and size of the first penetration segment are preferably selected such that, during the penetration process, the vessel or organ wall is displaced laterally by elastic deformation without being subject to uncontrolled tissue tears. A typical maximum outer diameter of the first penetration segment is on the order of 4 to 16 mm, preferably 11 mm.

[0012] Immediately after the first penetration body segment has completely penetrated the vessel or organ wall, the vessel or organ wall regenerates due to its inherent elastic restoring forces and preferably seals fluid-tight against the shaft assembly to which the segmented penetration body is attached.

[0013] Preferably, the shaft arrangement comprises at least two parallel-oriented individual shafts, each mounted to allow bidirectional and separate deflection, with the penetration body segments arranged at the distal ends of each shaft. Preferably, the individual shafts are tubular and arranged coaxially to each other.

[0014] The aforementioned first penetration body segment is attached distally to the inner single shaft, around which the vessel or organ wall preferably conforms in a largely fluid-tight manner after penetration by means of the first penetration body segment, especially since the penetration process takes place without or largely without any tissue removal.

[0015] Proximally, a second body segment, which radially defines a first cavity and terminates proximally with a radially circumferential cutting blade, connects seamlessly, i.e., monolithically, to the first body segment of the penetrating body, which tapers to a point. Preferably, the second body segment is designed in the form of a hollow cylinder and encloses a cylindrical cavity. By proximally withdrawing the first penetrating body segment from the interior of the vessel or organ, that portion of the vessel or organ wall is separated which, in axial projection to the longitudinal axis of the shaft, projects radially inward beyond the self-contained circumferential cutting blade. Tissue separation is achieved by incision or punching using the cutting blade, preferably assisted by a rotational movement superimposed on the axial proximal movement.by additional alternating rotational movements in the direction of rotation.

[0016] The resulting opening within the vessel or organ wall has a cross-sectional area that corresponds to the shape and size of the first penetrating body segment at its largest diameter or cross-section. In a preferred embodiment of the first penetrating body segment, which has a conically tapered first body section and a hollow cylindrical second body section adjoining it proximally, with a maximum outer diameter of 11 mm, a circular opening with a corresponding opening width of 11 mm is created after the first penetrating body segment is returned to an extraversive position relative to the vessel or organ.

[0017] For most therapeutic intracorporeal circulatory support systems that are surgically applied to the heart, particularly in the form of a pump for placement at the apex, openings with a width of less than 16 mm are too small. Therefore, the initial opening created by the first penetrating body segment must be widened by at least one further cutting or punching operation. For this purpose, the medical instrument according to this solution provides at least a second penetrating body segment, which has a recess on its distal side. This recess is preferably shaped and sized to completely accommodate the second body section of the first penetrating body segment. The second penetrating body segment, which is bidirectionally deflectable along a separate single shaft, is positioned proximally to the first penetrating body segment along the shaft assembly.

[0018] For the purpose of widening the initial opening created within the vessel or organ wall by means of the first penetration body segment, the second penetration body segment provides a first body section that tapers distally in cross-section and is preferably truncated cone-shaped, which, through the joint distal advancement of the first and second penetration body segments, is able to widen the initially created opening within the vessel or organ wall radially again without causing uncontrolled tears within the vessel or organ wall.

[0019] The second penetration body segment, like the first penetration body segment, has a second body section which is monolithically connected proximally to the first body section, which tapers distally in cross-section, and which at least partially radially limits a second cavity and has a cutting blade on the proximal side that radially surrounds the second cavity and radially limits the cavity which otherwise opens proximally.

[0020] After the first and second penetration body segments have been completely inserted or passed through the initial opening within the vessel or organ wall, the vessel wall narrows due to the elimination of the radial displacement force exerted by the second penetration body segment on the tissue surrounding the opening during the penetration process. This causes the vessel wall to revert to the shape and size of the initial opening. Preferably, the single shaft, at the distal end of which the second penetration body segment is attached, has a cross-section adapted to the initial opening, so that the edge of the opening fits snugly against the single shaft, ensuring a fluid-tight seal.

[0021] By proximal retraction of the first and second penetration body segments, an incision or punch is made using the cutting blade attached to the second penetration body segment. This incision or punch creates a tissue area, preferably ring-shaped, which extends inwards beyond the cutting blade in axial projection along the longitudinal axis of the shaft. The incision is preferably assisted by a rotational movement of at least the second penetration body segment around the longitudinal axis of the shaft.

[0022] The resulting larger opening in cross-section or diameter within the vessel or organ wall corresponds to the selected maximum outer diameter of the second penetrating body segment, which is, for example, between 8 and 26 mm, preferably 22 mm.

[0023] In a preferred embodiment, the distally tapering first body sections of the first and second penetration body segments are designed to be matched to each other in such a way that, in an axially joined state, i.e., the second body region of the first penetration body segment is completely inserted within the distal recess of the second penetration body segment, they form a uniform surface, preferably in the form of a straight cone.

[0024] Preferably, the first and second penetration body segments are rotationally symmetrical about the longitudinal axis of the shaft; that is, the first distally tapering sections of the first and second penetration body segments are conical or frustoconical, respectively, and the second sections of the first and second penetration body segments are hollow cylinders. However, it is equally conceivable to design the penetration body segments only axially symmetrical about the longitudinal axis of the shaft, for example, with a cross-sectional shape other than circular, such as elliptical, oval, or similar.

[0025] Another preferred embodiment of the medical instrument designed according to the solution provides a central passage channel that opens openly through the tip of the first penetrating body segment. This passage channel allows for the insertion of a guide wire, enabling precise guidance and navigation of the medical instrument relative to the vessel or organ wall. Alternatively, or in combination with the insertion of a guide wire, the passage channel also serves for the purpose of aspiration, injection of a gas or liquid, or the insertion of a catheter.

[0026] Naturally, the medical instrument designed according to this solution is not limited to a two-part segmentation of the penetrating body; rather, the penetrating body can be divided into three or more segments, depending on the desired opening size to be created in the vessel or organ wall. Thus, another preferred embodiment provides a third penetrating body segment, which is arranged along the shaft assembly proximal to the second penetrating body segment and is separately mounted to allow bidirectional deflection.The third penetration body segment is designed similarly to the second penetration body segment and has a first body section that tapers distally in cross-section, as well as a recess on its distal side oriented axially towards the second penetration body segment, into which the second body section of the second penetration body segment can be inserted, at least partially, preferably completely. The third penetration body segment also has a second body section adjoining the first body section of the third penetration body segment proximally, which at least partially radially delimits a second cavity and has a cutting blade on its proximal side that radially surrounds the second cavity.

[0027] All three penetration body segments described in the preceding embodiment, when assembled along the shaft, have a body section that tapers distally to a point and is composed of the first body sections of the first, second, and third penetration body segments, respectively. Further features and properties characterizing the first variant of the medical instrument designed according to the solution are explained below with reference to the illustrated embodiments.

[0028] A second embodiment of the medical instrument for creating an opening in a vessel or organ wall according to the features of the preamble of claim 2 is characterized in that the penetrating body comprises at least one first and one second penetrating body segment, which are mounted separately and bidirectionally deflectable from one another along the shaft assembly. In contrast to the first embodiment, the first penetrating body segment is designed in the form of a cutting sleeve, which has a cutting blade circumferentially on its distal side and radially delimits a first cavity that is open distally.

[0029] The second penetration body segment has a first body section that tapers distally in cross-section and has a recess oriented axially towards the first penetration body segment on the distal side, into which the first penetration body segment can be inserted at least partially, and has a second body section that radially limits a second cavity at least in some areas and has a cutting blade on the proximal side that radially surrounds the second cavity.

[0030] In a preferred embodiment, a fixing element, preferably shaped in a helical and / or barb-like form, is arranged within the recess oriented axially towards the first penetration body segment, which is suitable to penetrate the vessel or organ wall and anchor itself in it.

[0031] In contrast to the first described variant of the medical instrument, in which the incision process of tissue from the vessel or organ wall to create an opening is carried out exclusively from inside the vessel or organ through the vessel or organ wall to the outside, the initial opening through the vessel or organ wall is created with the aid of the second solution variant by distally advancing the cutting sleeve from the outside through the vessel or organ wall to the inside. Here, the cutting blade, which circumferentially surrounds the cutting sleeve on its distal side, cuts through the vessel or organ wall from the outside to the inside by distal advancement, preferably supported by twisting or rotational movements oriented around the longitudinal axis of the shaft.

[0032] To ensure that the first penetration segment completely pierces the vessel or organ wall, it must be advanced distally into the vessel or organ wall with a sufficiently great penetration depth. Preferably, a fixing element is arranged within the first penetration segment, which is designed in the manner of a cutting sleeve. This fixing element is capable of securing and, if necessary, compressing the tissue material separated from the vessel or organ wall within the first cavity. In the case of a helically shaped fixing element that is centrally arranged within the first cavity of the cutting sleeve, proximally oriented holding and compression forces directed towards the tissue material to be separated can be generated simply by rotation of the cutting sleeve. Further details can be found in the following description with reference to illustrated embodiments. Brief description of the invention

[0033] The invention is described below by way of example, without limiting the general concept of the invention, with reference to the drawings. The drawings show: Fig. 1a, b Representation of the medical instrument according to variant 1 in top view and longitudinal section view, Fig. 2 Longitudinal section through a penetration body consisting of two segments, Fig. 3 Longitudinal section through a penetration body consisting of two segments with a central hollow channel, Fig. 4a - e Sequence image representation for creating an opening in the area of ​​the apex of the heart using a suitably designed medical instrument with a penetration body consisting of two segments, Fig. 5 Longitudinal section through a solution-designed medical instrument with a penetration body consisting of three segments, Fig. 6 Longitudinal section through a penetration body consisting of three segments, Fig. 7 Longitudinal section through a penetration body consisting of three segments with a central hollow channel, Fig. 8 Longitudinal section through a displacement body with distal cutting sleeve, Fig. 9 Longitudinal section through a displacement body with distal cutting sleeve and central guide channel Fig. 10a - e Sequence image representations for creating an opening in a heart apex with a medical instrument according to variant 2. Ways to implement the invention, industrial applicability

[0034] Fig. Figure 1a shows a medical instrument 100 designed according to the solution for making an opening in a vessel or organ wall, especially within the myocardium in the region of the apex of the heart, in order to provide access to the left ventricle of the heart. Fig. 1b shows a longitudinal section view of the in Fig. Figure 1a illustrates a medical instrument 100. Reference is made to both illustrations in the following.

[0035] Within a tubular instrument housing 1, a shaft assembly 2 is arranged, which is mounted to deflect bidirectionally along its longitudinal axis A. The shaft assembly 1 comprises two individual shafts 3, 4, of which the centrally arranged, inner individual shaft 3 is surrounded by a radially surrounding, tubular outer individual shaft 4. Both individual shafts 3, 4 are connected at their proximal ends to a manually operated actuating element 5. The actuating element 5 is operatively connected to both the inner individual shaft 3 and the radially outer individual shaft 4. A manually operated locking element 7 can be temporarily engaged with the radially outer individual shaft 4 to lock it in place.Both individual shafts 3, 4 enable both a transmission of thrust and tensile forces oriented along the shaft's longitudinal axis A, as well as the possibility of performing rotational movements around the shaft's longitudinal axis A. In addition, a support element 6 is fixedly attached to the proximal area of ​​the instrument housing 1, which facilitates the manual operation of the individual shafts 3, 4 using the actuating means 5.

[0036] A penetration body 8 is attached to the distal end of the shaft assembly 1. In the illustrated example, this penetration body is composed of two separate penetration body segments 81 and 82. The first penetration body segment 81 is located at the distal end of the central single shaft 3, and the second penetration body segment 82 is attached to the distal end of the single shaft 4. Both penetration body segments 81 and 82 are located in the Fig. 1a, b are shown in an axially interlocked state, the so-called initial or basic state, and thus form a single penetration body 8, which has a first body section 10 tapering distally to a point, preferably conically, and a second body section 11 immediately adjoining it proximally, preferably in a hollow cylindrical form. The penetration body segments 81, 82, which compose the penetration body 8, are each shown in two different embodiments in detail in the Fig. 2 and Fig. 3 shown. Fig. 2 and Fig. Figures 3 each represent longitudinal sections of the penetration body 8, which is composed of the two penetration body segments 81, 82, and show a proximal area of ​​the instrument housing 1 immediately adjoining it.

[0037] The first penetration body segment 81, attached to the distal end of the central single shaft 3, consists of a first body section 811 tapering distally to a distal tip 9 and a second body section 812 monolithically adjoining this body section proximally, the latter radially limiting a first cavity 8121 and closing proximally with a cutting blade 813 that completely encloses the first cavity 8121 radially.

[0038] The first penetration body segment 81 is mounted bidirectionally along the shaft longitudinal axis A separately from the second penetration body segment 82 and relative to the instrument housing 1 by means of the central single shaft 3.

[0039] The second penetration body segment 82, like the first penetration body segment 81, has a first body section 821 that tapers distally and a second body section 822 that monolithically adjoins it proximally and borders a second cavity 8221 and has a cutting blade 823 that radially surrounds the second cavity 8221 proximally.

[0040] Furthermore, the second penetration body segment 82 has a distally axially oriented recess 84, which is adapted in shape and size to the outer contour of the second body section 812 of the first penetration body segment 81, so that the latter can be fully inserted into the recess 84, as shown from Fig. 2 can be seen. The second penetration body segment 82 is attached distally to the tubular single shaft 4, over which it is bidirectionally deflectable along the shaft longitudinal axis A and rotatable about the shaft longitudinal axis A.

[0041] In the Fig. In the embodiment shown in Figure 2, the first and second penetration body segments 81, 82 and the instrument housing 1 are rotationally symmetrical about the longitudinal axis A of the shaft, i.e., the outer contours of the first and second body sections 811, 812, 821, 822 of the first and second penetration body segments 81, 82 together form a conical geometry, to which the cylindrical outer contour of the second body section 822 of the second penetration body segment 82 seamlessly connects. In the embodiment shown in Figure 2, the first and second penetration body segments 81 and 82 are formed by the first and second penetration body segments 81 and 82 together form a conical geometry, to which the cylindrical outer contour of the second body section 822 of the second penetration body segment 82 seamlessly connects. Fig. In the constellation of both penetration body segments 81, 82 shown in Figure 2, the proximal end of the second body section 822 of the second penetration body segment 82 also opens into an axially concentric recess 12 distally within the instrument housing 1, with the cutting blade 823 of the second penetration body segment 82 touching the instrument housing 1 at its frontal end.

[0042] In contrast to a rotationally symmetric design of both penetration body segments 81, 82 and of the instrument housing 1, axially symmetric shapes with respect to the shaft longitudinal axis A are also conceivable, e.g. a first and second penetration body segment with cross-sections deviating from the circular shape, e.g. in the form of oval or elliptical or similarly axially symmetric cross-sectional shapes.

[0043] The in Fig. The illustrated embodiment in section 3 differs from the one in Fig. Figure 2 illustrates the longitudinal section by the fact that a hollow channel 13 is introduced along the longitudinal axis A of the shaft, which projects through the first penetration body segment 81 at its tip 9. The hollow channel 13 extends, as shown in Figure 2, Fig. As can be seen in Figure 1b, the central single shaft 3 and the actuating element 5 connected to the central single shaft 3 are also penetrated. In this way, it is possible to use the hollow channel 13 as a passageway for a guide wire or a catheter from the actuating element 5. Alternatively, the hollow channel 13 can also be used for the purpose of aspiration or injection of gases or liquids.

[0044] The Fig. Figures 4a - e represent sequence images that illustrate, in chronological order, the creation of an opening in the area of ​​the apex of the heart within the heart wall (myocardium) to create access to the left ventricle. Fig. Figure 4a shows the positioning of the medical instrument 100 relative to the apex of the heart (HS), where an opening is to be made locally in the heart wall (15). Optionally, a guide wire 14 has been inserted through the apex of the heart, e.g., by means of a previously performed puncture, which serves for precise and facilitated navigation of the medical instrument 100. After positioning the medical instrument 100 outside the apex of the heart (HS), as shown in Figure 4a, the opening is made in the heart wall (15). Fig. As shown in Figure 4a, the first penetration body segment 81 is driven through the heart wall 15 in a separate distally directed advance along the longitudinal axis A of the shaft. During penetration, the first penetration body segment 81 radially expands the cardiac muscle tissue at the point of penetration. After the first penetration body segment 81 has completely passed through the heart wall 15, the tissue conforms tightly to the central single shaft 3 due to the elastic restoring forces that develop locally in the cardiac muscle, as shown in Figure 4a. Fig. 4b is evident.

[0045] The shape, size, and, in particular, the maximum outer diameter of the first penetration body segment 81 are selected such that the heart wall 15 experiences as few tissue tears as possible during penetration. The maximum outer diameter of the first penetration body segment 81 should not exceed 16 mm, preferably measuring 11 mm. The second penetration body segment 82, as well as the instrument housing 1 immediately adjoining it proximally, preferably remain in their initial position outside the heart during the initial penetration process.

[0046] In Fig. Figure 4c illustrates the situation after the first penetrating body segment 81, positioned within the left ventricle, has been withdrawn proximally through the heart wall 15, with the second body section 812 of the first penetrating body segment 81 being completely inserted into the recess 84 of the second penetrating body segment 82. During the proximal passage of the first penetrating body segment 81 through the heart wall 15, the wall is completely and locally transected by incision using the cutting blade 813 provided proximally on the first penetrating body segment 81, forming an opening. The tissue area separated from the rest of the heart wall 15 by the incision or punching enters the first cavity 8121 of the first penetrating body segment 81 and is inserted therein, in conjunction with the second penetrating body segment 82, into the cavity 8121 of the first penetrating body segment 81. Fig. The condition illustrated in 4c is safely preserved. The incision process creates an initial opening 16 within the heart wall 15.

[0047] Immediately following this, to enlarge the initial opening 16, the second penetrating body segment 82, together with the first penetrating body segment 81, is advanced distally through the opening 16 within the heart wall 15. During the penetration process of the now first and second penetrating body segments 81, 82, the cardiac muscle tissue around the opening 16 is again expanded radially elastically. After complete insertion of the first and second penetrating body segments 81, 82 into the left ventricle, this tissue elastically regresses radially. Fig. Figure 4d illustrates the position in which both penetration body segments 81, 82 have penetrated the heart wall 15 through the opening 16. Preferably, however, in Fig. 4d not illustrated, the lateral opening wall of the initial opening 16 lies as fluid-tight as possible against the outer single shaft 4.

[0048] By repeatedly retracting both penetration body segments 81, 82 proximally, the initial opening 16 is radially widened by the incisive action of the cutting blade 823, now positioned at the proximal end of the second penetration body segment 82, forming a larger opening 17. Through this incision, the ring-shaped cardiac tissue detached from the heart wall 15 enters the second cavity 8221 of the second penetration body segment 82, where it is securely contained within the cavity by the instrument housing 1.

[0049] By successively increasing the diameter of the initial opening 16 to the larger opening 17, the cross-sectional size of which depends on the maximum outer diameter of the second penetrating body segment 82, the surgical procedure can be completed or continued as appropriate, depending on the further course of therapy. Should the opening width of the Fig. If the opening 17 shown in section 4e is not sufficient, at least one further, third penetration body segment 83 can be provided by suitable selection of the appropriate medical instrument 100'.

[0050] One such embodiment is in Fig. 5 illustrated as a longitudinal section, which complements the one in Fig. Figure 1b illustrates a longitudinal section showing a third penetration body segment 83, which is similar to the second penetration body segment 82 and has a first body section 831 that tapers distally in cross-section; see in particular the supplementary detailed illustrations in Fig. 6 and Fig. 7. In the same way as the second penetration body segment 82, a second body segment 832 adjoins the first body segment 831 of the third penetration body segment 83. This second body segment radially defines a third cavity 8321 and has a cutting blade 833 on its proximal side that radially surrounds the third cavity 8321. The respective maximum outer diameters of the three displacement body segments 81, 82, 83 are coordinated such that, upon penetrating the heart wall 15 or an opening 16 already present in the heart wall 15, they are able to expand the cardiac muscle tissue adjacent to the respective displacement body segments preferably exclusively elastically, without causing irreversible traumatic tissue tears.Preferred outer diameters for the displacement body segments 81, 82, 83 are as follows: Displacement body segments 81: 4 to 16 mm, preferably 11 mm; Displacement body segments 82: 8 to 26 mm, preferably 22 mm; Displacement body segments 83: 12 to 36 mm, preferably 33 mm.

[0051] It should also be mentioned that the third displacement body segment 83 is attached to the distal end of a third tubular single shaft 18, at the proximal end of which, as with the other single shafts 3, 4, a manual actuating means is attached. Furthermore, the third displacement body segment 83 has a recess 843 on its distal side, oriented axially towards the second penetration body segment 82, into which the second body section 822 of the second penetration body segment 82 can be inserted, at least partially, preferably completely.

[0052] Unlike the one in Fig. The 6 illustrated longitudinal section shows this in Fig. Figure 7 illustrates an additional hollow channel 13 arranged centrally to the longitudinal axis A of the shaft, through which, as already mentioned above, for example a guide wire 14 can be passed.

[0053] In Fig. Figure 8 shows a longitudinal section through the second variant of the medical instrument 100 designed according to the solution. Fig. Figure 8 shows the distal area of ​​the medical instrument 100, comparable to that in Fig. 2 shown representation form, which illustrates the first variant of the solution-oriented medical instrument.

[0054] The second variant also features a segmented penetration body 8' arranged along a shaft assembly 2'. Unlike the first variant, the first penetration body segment 81' is designed as a cutting sleeve, which has a cutting blade 19 circumferentially on its distal side and radially delimits a first cavity 20 that is open distally. The first penetration body segment 81' terminates proximally with a sleeve base 21, which is firmly connected to the central single shaft 3'.

[0055] In a preferred embodiment, a fixing element 22 is arranged within the cavity 20, which is designed to penetrate the vessel or organ wall and anchor itself therein. The in Fig. The fixing element 22, illustrated in Figure 8, is designed in a helical structure which, by rotating the first penetration body segment 81' about the longitudinal axis A of the shaft, spirals into the fabric material to form a shear and tensile-resistant joint. The fixing element 22 is preferably attached to the proximal side of the sleeve base 21.

[0056] The second penetration body segment 82' is comparable to the second penetration body segment 82 of the Fig. The first variant of the medical instrument 100 is illustrated in Figures 1 to 7. The second penetration body segment 82' has a first body section 821' that tapers distally in cross-section and a second body section 822' immediately adjoining it proximally. The second penetration body segment 82' has a distally open recess 84' into which the first penetration body segment 81' can be inserted, at least partially, preferably completely. Furthermore, the second body section 822' radially defines a second cavity 8221', which terminates proximally with a radially circumferential cutting blade 823'.

[0057] In the Fig. In the axially interlocked position of both penetration body segments 81', 82' shown in Figure 8, the cutting blade 823' abuts the end face of the instrument housing 1 in a distally oriented recess 12'. The second penetration body segment 82' is fixedly attached to the distal end of a tubular single shaft 4' for bidirectional deflection along the shaft's longitudinal axis A. Preferably, the first and second penetration body segments 81', 82' are rotationally symmetrical. In this case, the first body section 821' of the second penetration body segment 82' is frustoconical, and its second body section 822' is hollow cylindrical. However, it is also possible to design the penetration body segments 81', 82' together with the instrument housing 1' axially symmetric to the shaft longitudinal axis A, e.g. with an elliptical or oval or similar cross-sectional shape.

[0058] The in Fig. Figure 9 illustrates an embodiment with Fig. 8 comparable longitudinal section, in which, however, a hollow channel 13' additionally leads through the central single shaft 3', e.g. for the passage of a guide wire 14.

[0059] The Fig. Figures 10a to e represent sequence images illustrating the creation of an opening within an organ wall, preferably a heart wall 15. Fig. 10a The medical instrument 100' is oriented externally towards the apex HS of the heart. Not necessarily, but advantageously, a guide wire 14 is inserted through the heart wall 15 by a suitable puncture. The medical instrument 100' is positioned along the guide wire 14 relative to the apex HS on the heart wall 15, as shown in Fig. As shown in Figure 10a. In a first step, the first penetration body segment 81' is advanced distally along the guide wire 14 into the heart wall 15 in a penetrating manner, whereby the cutting blade 19, located distally on the first penetration body segment 81', is able to locally penetrate the heart wall 15. The cutting process, which is essentially caused by the distal advancement of the first penetration body segment 81', can preferably be supported by an additional rotation of the first penetration body segment 81' about the longitudinal shaft axis A.

[0060] The cardiac muscle tissue, separated from the heart wall 15 by incision, penetrates the cavity 20 of the first penetration body segment 81'. To support the penetration of the separated cardiac muscle tissue into the cavity 20 and to ensure that the separated cardiac muscle tissue remains within the cavity 20, a helically shaped fixation element 22 is inserted within the cavity 20, which is capable of forming a pressure- and tensile-resistant connection with the separated cardiac muscle tissue ( Fig. 10b).

[0061] In Fig. Figure 10c illustrates the state after proximal retraction of the first penetrating body segment 81' into the recess 84' of the second penetrating body segment 82'. The cardiac muscle tissue separated from the heart wall 15 remains within the cavity 20, forming an initial opening 16 within the heart wall 15. The formation of the initial opening 16 thus occurred by means of an external-to-internal advancement of the first penetrating body segment 81' relative to the heart wall 15.

[0062] For the purpose of widening the initial opening 16 within the heart wall 15, in a subsequent penetration process the second penetration body segment 82' is pierced through the initial opening 16, with elastic radial expansion of the cardiac muscle tissue immediately adjacent to the opening 16, which, after complete joint penetration of the penetration body segments 81', 82', as in Fig. 10d shown, radially elastically returns to its original state ( Fig. 10d). The shape and size of the second penetration body segment 82' are chosen such that the cardiac muscle tissue adjacent to the opening 16 does not suffer any traumatic injury during the penetration process. In particular, it is important to avoid uncontrolled tissue tears during the penetration process.

[0063] In Fig.Figure 10e shows the state after proximal retraction of the second penetrating body segment 82', within whose recess 84' the first penetrating body segment 81' together with the separated cardiac muscle tissue contained therein is arranged. During proximal retraction, the cutting blade 823' severs the cardiac muscle tissue projecting radially inward relative to the cutting blade 823', forming a significantly widened opening 17 within the cardiac wall 15. The tissue portion separated from the cardiac wall 15 by the incision is transferred and remains for safe storage in the second cavity 8221' of the second penetrating body segment 82'.

[0064] Both variants for forming the appropriate medical instrument have the advantage that, at least for the formation of the widened opening 17 within the heart wall 15 or vessel or organ wall, the incision is made from the inside out, i.e. from the inside out, thus ensuring a complete severing of the heart wall. Reference symbol list A shaft longitudinal axis HS Heart apex 1 instrument housing 2 shaft arrangement 3.3' Single unit 4.4' Single shaft 5 Actuators 6 shoring devices 7 Fixing element 8 Penetrating bodies 81, 81' first penetration body segment 811 first body section of the first penetrating body segment 812 second body section of the first penetrating body segment 8121 first cavity 813 Cutting blade 82, 82' second penetration body segments 821, 821' first body section of the second penetrating body segment 822, 822' second body section of the second penetration body segment 8221, 8221' second cavity 823, 823' cutting blade 83 third displacement body segment 831 first body section of the third displacement body segment 832 second body section of the third displacement body segment 8321 third cavity 833 Cutting blade 84, 843, 84' recess 9 top 10 first conically tapering body section 11 second cylindrical body section 12 distal recess 13 Hollow channel 14 guide wire 15 Organ wall, heart wall, vessel wall 16 initial opening 17 widened opening 18 tubular single shaft 19 cutting blade 20 first cavity 21 shell base 22 Fixing element 100 medical instruments QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] US 2007 / 0167968 A1

[0005] US 11,925,382 B2

[0005] US 2008 / 0009891 A1

[0006]

Claims

[1] Medical instrument (100) for producing an opening (17) in a vessel or organ wall (15) with a penetration body (8) attached distally to a shaft arrangement (2) having a shaft longitudinal axis (A), the penetration body having a first body section (10) and a second body section (11) adjoining the first body section (10) proximally, the latter having at least partially bounding a cavity radially to the shaft longitudinal axis and having a cutting blade radially enclosing the cavity proximally, characterized by, that the penetration body (8) is composed of at least one first and one second penetration body segment (81, 82) which are axially mounted one behind the other and separately from each other in a bidirectionally deflectable manner along the shaft arrangement (2) and each have a first body section (811, 821) that tapers distally in cross-section and a second body section (821, 822), that the first body section (811) of the first penetration body segment (81) terminates distally, forming a tip (9), and the second body section (812) adjoining the first body section (811) proximally at least partially radially limits a first cavity (8121) and has a cutting blade (813) radially enclosing the first cavity (8121) proximally, and that the first body section (821) of the second penetration body segment (82) has a distally tapered cross-section and a distally oriented recess (84) into which the second body section (812) of the first penetration body segment (81) can be inserted at least partially, and the second body section (822) adjoining the first body section (821) of the second penetration body segment (82) at least partially radially limits a second cavity (8221) and has a cutting blade (823) radially enclosing the second cavity (8221) on the proximal side. [2] Medical instrument (100') for making an opening (17) in a vessel or organ wall (15) with a penetration body (8) attached distally to a shaft arrangement (2) having a shaft longitudinal axis (A), the penetration body having a first body section (10) and a second body section (11) adjoining the first body section (10) proximally, the latter having at least partially bounding a cavity radially to the shaft longitudinal axis and having a cutting blade radially enclosing the cavity proximally, characterized by , that the penetration body (8) is composed of at least one first and one second penetration body segment (81', 82') which are mounted separately from each other in a bidirectionally deflectable manner along the shaft arrangement (2), that the first penetration body segment (81') is designed in the form of a cutting sleeve, which has a circumferential cutting blade (19) on its distal side and radially limits a first cavity (20) that is open on its distal side, and that the second penetration body segment (82') has a first body section (821') that tapers distally in cross-section and has a recess (84') oriented axially towards the first penetration body segment (81') distally, into which the first penetration body segment (81') can be inserted at least partially, and a second body section (822') that radially limits at least a second cavity (8221') in some areas and has a cutting blade (823') radially enclosing the second cavity (8221') proximally. [3] Medical instrument according to claim 1 or 2, characterized by, that the shaft arrangement (2) has at least two parallel oriented individual shafts (3, 3', 4, 4') each mounted bidirectionally separately deflectable, at the distal shaft ends of which one of the at least two penetration body segments (81, 81', 82, 82') is arranged. [4] Medical instrument according to claim 3, characterized by , that the at least two individual shafts (3, 3', 4, 4') are arranged coaxially to each other, of which at least one individual shaft is tubular in shape. [5] Medical instrument according to any one of claims 1 to 4, characterized by , that the at least two penetration body segments (81, 81', 82, 82') are axially or rotationally symmetrical to the longitudinal axis of the shaft. [6] Medical instrument according to any one of claims 1, 3 to 5, characterized by, that the recess (84) of the second penetration body segment (82) is dimensioned in shape and size to fully accommodate the second body section (812) of the first penetration body segment (81). [7] Medical instrument according to any one of claims 1, 3 to 6, characterized by , that the first body section (811) of the first penetrating body segment (81) has a hollow canal (13) extending through the tip (9). [8] Medical instrument according to claim 7, characterized by , that the hollow channel (9) is dimensioned, designed and arranged to allow passage of a guide wire (14), aspiration, injection of a gas or liquid or passage of a catheter. [9] Medical instrument according to any one of claims 1, 3 to 8, characterized by, that the first body section (811) of the first penetration body segment (81), which tapers distally in cross-section, and the first body section (821) of the second penetration body segment (82), which tapers distally in cross-section, form a uniformly connected surface in the form of a straight cone in an axially interlocked state of the first and second penetration body segments (81, 82). [10] Medical instrument according to any one of claims 1, 3 to 8, characterized by, that a third penetration body segment (83) is provided, which is arranged along the shaft arrangement (2) proximal to the second penetration body segment (82) and is separately mounted to be bidirectionally deflectable, that the third penetration body segment (83) is formed similarly to the second penetration body segment (82) and has a first body section (831) tapering distally in cross-section and a recess (843) oriented axially towards the second penetration body segment (82) on the distal side, into which the second body section (822) of the second penetration body segment (82) can be at least partially inserted, and has a second body section (832) adjoining the first body section (831) of the third penetration body segment (83) on the proximal side,which at least partially radially limits a second cavity (8321) and has a cutting blade (833) radially enclosing the second cavity (8321) on the proximal side. [11] Medical instrument according to any one of claims 2, 3 to 5, characterized by , that within the first cavity (20) a fixing element (22) is arranged which is designed to penetrate the vessel or organ wall (15) and to anchor itself in it. [12] Medical instrument according to claim 11, characterized by that the fixing element (22) is helical and / or shaped like a barb.

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