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

Abstract

The invention relates to a medical instrument for producing an opening in a vessel or organ wall, having a penetrating body that is attached on the distal side to a shaft assembly having a shaft longitudinal axis and that has a first body section and a second body section adjoining the first body section on the proximal side, wherein the second body section delimits a cavity radially to the shaft longitudinal axis at least in some regions and has a cutting blade radially surrounding the cavity on the proximal side. The invention is characterised in that the penetrating body is composed of at least a first and a second penetrating body segment, which have a first and a second body section. The first body section of the first penetrating body segment ends at the distal end with a tip, and the second body section delimits a first cavity at least in some regions and has a cutting blade which radially surrounds the first cavity. The first body section of the second penetrating body segment tapers in the distal direction in the cross-section and has a recess facing the first penetrating body segment on the distal side, into which recess the second body section of the first penetrating body segment can be partially inserted. Furthermore, the second body section delimits a second cavity in some regions and has a cutting blade that radially surrounds the second cavity.

Description

[0001] Medical instrument for creating an opening in a vessel or organ wall

[0002] Technical field

[0003] 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 having 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.

[0004] Ventricular assist devices (LVADs), most commonly left ventricular assist devices, are implanted in patients with end-stage heart failure whose ventricular output into the systemic circulation (less frequently the pulmonary circulation) is reduced. Conventional VADs essentially consist of an inflow cannula, which usually directs blood from the left ventricle to the heart pump at the apex of the heart, the heart pump itself, and an outflow vascular prosthesis, which typically carries the blood to the aorta near the heart. To insert the inflow cannula into the ventricle, it is necessary to cut or punch an opening in the apex of the heart (a process known as coring), and subsequently to attach the inflow cannula and the heart pump to the heart wall, protruding through or into this opening.

[0005] Conventional techniques for VAD implantation involve the use of a heart-lung machine (HLM). However, this technique has numerous disadvantages, as the use of the HLM requires venous and arterial cannulation, and its operation is complex and associated with many potential complications.

[0006] State of the art

[0007] Various cutting and punching tools are available for creating a hole in the heart wall at the apex. One cutting tool used in medical applications, manufactured by Abbott Laboratories (Abbott Park, Illinois, USA), and marketed in Germany by Abbott GmbH (Wiesbaden), is called the "HeartMate 3 Coring Tool." It features a hollow cylindrical cutting sleeve with a cutting blade encircling the distal side. Inside this sleeve are a guide needle that extends distally beyond the cutting blade and is centered on the sleeve, as well as a spiral that coaxially surrounds the guide needle and is positioned downstream of its tip.After suturing and fixing a retaining ring at the apex of the heart, the punching tool is guided through the circular opening of the retaining ring towards the heart wall. The guide needle serves to center and direct the cutting tool's further distal advance. Once the spiral makes contact with the outer layer of the heart wall, the cutting tool and the spiral, which is rigidly connected to it, are inserted into the heart wall under rotation. With slight tension applied along the spiral, the cutting sleeve is then rotated into the heart wall and through its inner layer.

[0008] However, a successful and complete transection of the three-layered heart wall (consisting of the outer, middle and inner layers, technically called epicardium, myocardium and endocardium) only occurs if the cutting sleeve is completely inserted from the outside in through the heart wall and this is transected along the full circumference of the cutting blade.

[0009] 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 connects proximally to the first body section. 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 heart chamber 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 entering the heart chamber 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 outer layer of the heart wall (epicardium) and, in particular, the removal of the punching tool from the heart chamber are difficult.The procedure can only be performed on the heart wall using a heart-lung machine (HLM), as otherwise blood would flow uncontrollably from the heart chamber to the outside. A similar punching tool can be found in the publications US 11,925,382 B2, US 2003 / 0040765 A1, US 2004 / 0073247 A1, CN 103584904 A, and CN 104337553 A.

[0010] Another surgical punching device 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, which cuts the heart wall from the outside in, interacts with a protective counter-shield pre-positioned inside the heart chamber in such a way that immediately after the punch hole is created in the heart wall, the counter-shield is intended to seal the hole fluid-tight by completely surrounding the hole at its periphery against the inner heart wall. A disadvantage of this medical arrangement is that the insertion of the counter-shield, especially into the left ventricle, is performed by means of a cardiac catheterization through the aorta, which represents an additional burden for the patient and can be associated with complications.The counter-shield must subsequently be very securely fixed to the inner wall of the heart to serve as a support for the punching tool and furthermore ensure that the hole in the heart wall is sealed against blood leakage in order to allow subsequent implantation of a cardiac support system without the use of a heart-lung machine.

[0011] Document CN 104997552 A discloses a surgical trepanation knife for cutting an open hole in biological tissue and for removing the cut tissue at the opening. For this purpose, a cylindrical knife for cutting the open hole in the biological tissue and a gripping mechanism in the form of a corkscrew for grasping the cut tissue at the open opening are provided. The cylindrical knife is tubular and includes a distal end with a cylindrical cutting edge. The gripping mechanism is longitudinally movable and rotatable inside the tubular knife.

[0012] Description of the invention

[0013] 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 protruding at the edge of the opening due to incomplete cutting, and secondly, it should be possible to introduce the opening into 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 heart chamber, should be necessary.

[0014] 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.

[0015] 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 truncated cone-shaped 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. Furthermore, the second body section, which adjoins the first body section of the second penetration body segment proximally, radially defines a second cavity, at least in some areas, and also has a cutting blade on its proximal side that radially surrounds the second cavity.

[0016] 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 outer heart wall. This would otherwise necessitate immobilizing the heart using cardiopulmonary bypass and cardioplegia to prevent the risk of uncontrolled perforation. Instead, the instrument-based penetration of the vessel or organ wall is intended to 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 upon severing the wall, and without interrupting organ function or blood flow.For this purpose, the medical instrument according to the solution has a segmented penetration body which is composed of at least two penetration body segments, each of which differs in its maximum outer diameter, thereby increasing the opening or

[0017] The formation of a hole within the vessel or organ wall occurs successively and stepwise. The first penetration segment, which has a distal tip and widens radially, preferably conically, proximally, is able to penetrate the vessel or organ wall from the outside, generally without prior preparation of the outer wall, by advancing distally. During penetration of the vessel or organ wall by means of the first penetration segment, the wall is displaced radially by the segment and slides along the outer contour of the first penetration segment during penetration. 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 body segment is on the order of 4 mm to 16 mm, preferably 11 mm.

[0018] 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.

[0019] Preferably, the shaft arrangement has at least two parallel oriented individual shafts, each of which is mounted to be separately deflectable in a bidirectional manner, with the penetration body segments arranged at the distal ends of each shaft.

[0020] Preferably, the individual shafts are tubular in shape and arranged coaxially to each other.

[0021] 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.

[0022] 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 cutting or punching with the cutting blade, preferably supported by a rotational movement superimposed on the axial proximally directed movement.by additional alternating rotational movements in the direction of rotation.

[0023] 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 diameter of 11 mm is formed after the first penetrating body segment is returned to a position outside the vessel or organ.

[0024] For most intracorporeal cardiac support systems, openings with widths smaller than 16 mm are too small, so the initial opening created by the first penetration segment must be enlarged by at least one further cutting or punching operation. For this purpose, the medical instrument according to the solution provides at least a second penetration 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 penetration segment. The second penetration segment, which is mounted to be bidirectionally deflectable along a separate shaft, is positioned proximally to the first penetration segment along the shaft assembly.

[0025] 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.

[0026] 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 proximally surrounding the second cavity, which radially limits the cavity that otherwise opens proximally.

[0027] 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 against the single shaft as fluid-tight as possible.

[0028] By proximal retraction of the first and second penetration body segments, a tissue area, preferably ring-shaped and projecting inwards beyond the cutting blade in axial projection along the longitudinal axis of the shaft, is separated from the remaining vessel or organ wall by means of the cutting blade attached to the second penetration body segment. This separation is dependent on the shape and size of the cutting blade. The cutting or punching process is preferably assisted by a rotational movement of at least the second penetration body segment oriented around the longitudinal axis of the shaft. The resulting larger opening in the vessel or organ wall, in terms of cross-section or diameter, corresponds to the selected maximum outer diameter of the second penetration body segment, which is, for example, between 8 mm and 26 mm, preferably 22 mm.

[0029] 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 an almost uniform surface, preferably in the form of a straight cone.

[0030] 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 also 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 an elliptical, oval, or similar shape.

[0031] 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.

[0032] The medical instrument designed according to this solution is not limited to a two-part segmentation of the penetrating body. 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. For example, another preferred embodiment provides a third penetrating body segment, which is arranged proximal to the second penetrating body segment along the shaft assembly and is separately mounted to allow bidirectional deflection. The third penetrating body segment is similar in design to the second penetrating 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 penetrating body segment, into which the second body section of the second penetrating 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 on a proximal side, which at least partially radially limits a second cavity and has a cutting blade radially enclosing the second cavity on a proximal side.

[0033] All three penetration body segments described in the preceding embodiment have, when assembled along the shaft assembly, 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. A second variant of the medical instrument designed according to the solution 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 penetration body is composed of at least one first and one second penetration body segment, which are mounted separately along the shaft assembly so as to be bidirectionally deflectable from one another.In contrast to the first variant, the first penetration body segment is designed in the form of a cutting sleeve, which has a cutting blade circumferential on the distal side and radially limits a first cavity open on the distal side.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] Brief description of the invention

[0039] 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:

[0040] Fig. 1 a, b Representation of the medical instrument according to variant 1 in top view and longitudinal section view,

[0041] Fig. 2 Longitudinal section through a penetration body consisting of two segments,

[0042] Fig. 3 Longitudinal section through a penetration body consisting of two segments with a central hollow channel,

[0043] 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,

[0044] Fig. 5 Longitudinal section through a medical instrument designed according to the solution with a penetration body consisting of three segments,

[0045] Fig. 6 Longitudinal section through a penetration body consisting of three segments,

[0046] Fig. 7 Longitudinal section through a penetration body consisting of three segments with a central hollow channel,

[0047] Fig. 8 Longitudinal section through a displacement body with distal cutting sleeve,

[0048] Fig. 9 Longitudinal section through a displacement body with distal cutting sleeve and central guide channel

[0049] Fig. 10a - e Sequence image representations for creating an opening in the apex of the heart with a medical instrument according to variant 2.

[0050] Ways to implement the invention, industrial applicability

[0051] Figure 1a shows a medical instrument 100 designed according to the solution for creating an opening in a vessel or organ wall, particularly in the region of the apex of the heart, in order to provide access to the heart chamber. Figure 1b shows a longitudinal section of the medical instrument 100 illustrated in Figure 1a. Reference is made to both figures below.

[0052] 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.

[0053] A penetration body 8 is attached to the distal end of the shaft assembly 2. 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 arranged 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 shown in Figures 1a and 1b in an axially interlocked state, the so-called initial or basic state, and thus form a single penetration body 8. This penetration body has a first body section 10 that tapers distally to a point, preferably conically, and a second body section 11 that is immediately adjoining it proximally and is preferably hollow and cylindrical in shape.The penetration body segments 81 and 82, which comprise the penetration body 8, are each shown in detail in two different embodiments in Figures 2 and 3. Figures 2 and 3 each depict longitudinal sections of the penetration body 8, which is composed of the two penetration body segments 81 and 82, and show a proximally adjacent area of ​​the instrument housing 1.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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

[0058] The penetration body segment 81 is adapted so that it can be fully inserted into the recess 84, as can be seen in Figure 2. The second penetration body segment 82 is attached distally to the tubular single shaft 4, via which it is bidirectionally deflectable along the shaft's longitudinal axis A and rotatable about the shaft's longitudinal axis A.

[0059] In the embodiment shown in Figure 2, the first and second penetration body segments 81, 82 and the instrument housing 1 are rotationally symmetric about the shaft longitudinal axis A, 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 or cone-shaped geometry, to which the cylindrical outer contour of the second body section 822 of the second penetration body segment 82 seamlessly connects. 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 end face.

[0060] 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.

[0061] The embodiment illustrated in Figure 3 differs from the longitudinal section illustrated in Figure 2 in that a hollow channel 13 is provided along the longitudinal axis A of the shaft, which extends through the tip 9 of the first penetration body segment 81. As can be seen in Figure 1b, the hollow channel 13 extends through the central single shaft 3 and also penetrates the actuating element 5 connected to the central single shaft 3. 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.

[0062] Alternatively, the hollow channel 13 can also be used for the purpose of aspiration or injection of gases or liquids.

[0063] Figures 4a-e depict sequence images illustrating, in chronological order, the creation of an opening in the region of the apex of the heart within the heart wall to provide access to the heart chamber. Figure 4a shows the positioning of the medical instrument 100 relative to the apex HS, where an opening is to be created locally in the heart wall 15. Optionally, a guide wire 14 has been inserted through the apex of the heart, for example, 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 HS, 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, which, after complete passage of the first penetration body segment 81 through the heart wall 15, fits snugly against the central single shaft 3 due to the elastic restoring forces that develop locally in the cardiac muscle, as can be seen in Figure 4b.

[0064] The shape and 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.

[0065] Figure 4c illustrates the situation after the first penetrating body segment 81, positioned within the heart chamber, 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 proximally directed passage of the first penetrating body segment 81 through the heart wall 15, the wall is completely locally incised by means of the cutting blade 813 provided on the proximal side of 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 penetration body segment 81 and is safely contained therein in conjunction with the second penetration body segment 82 in the state illustrated in Figure 4c.The incision process creates an initial opening 16 within the heart wall 15.

[0066] Immediately following this, to enlarge the initial opening 16, the second penetration body segment 82, together with the first penetration 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 penetration 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 penetration body segments 81, 82 into the left ventricle, the tissue elastically retracts radially. Figure 4d illustrates the position in which both penetration body segments 81, 82 have penetrated the heart wall 15 through the opening 16. Preferably, but not illustrated in Figure 4d, the lateral wall of the initial opening 16 lies as fluid-tight as possible against the outer single shaft 4.

[0067] 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.

[0068] 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 procedure can be completed or continued as appropriate, depending on the further course of therapy. Should the opening width of the opening 17 illustrated in Figure 4e be insufficient, at least one further, third penetrating body segment 83 can be provided by appropriately selecting the corresponding medical instrument 100'.

[0069] Such an embodiment is illustrated in Figure 5 as a longitudinal section, which, in addition to the longitudinal section illustrated in Figure 1b, has a third penetration body segment 83, which is similarly designed 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 Figures 6 and 7. In the same way as the second penetration body segment 82, a second body section 832 adjoins the first body section 831 of the third penetration body segment 83. This second body section 832 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 they each, when penetrating the heart wall 15 or 833, respectively, are appropriately sized.The displacement body segments, through an opening 16 already present in the heart wall 15, 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:

[0070] Displacement body segments 81: 4 mm to 16 mm, preferably 11 mm; Displacement body segments 82: 8 mm to 26 mm, preferably 22 mm; Displacement body segments 83: 12 mm to 36 mm, preferably 33 mm

[0071] 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 on 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.

[0072] In contrast to the longitudinal section illustrated in Figure 6, the embodiment illustrated in Figure 7 additionally provides a hollow channel 13 arranged centrally to the longitudinal axis A of the shaft, through which, as already mentioned above, a guide wire 14 can be passed, for example.

[0073] Figure 8 shows a longitudinal section through the second variant of the solution-formed medical instrument 100. Figure 8 shows the distal region of the medical instrument 100, comparable to the representation shown in Figure 2, which illustrates the first variant of the solution-formed medical instrument.

[0074] 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'.

[0075] 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 fixing element 22, illustrated in Figure 8, is designed as a helical structure which, by rotating the first penetration body segment 81' about the longitudinal axis A of the shaft, spirals into the tissue material to form a shear and tensile-resistant connection. The fixing element 22 is preferably attached to the proximal side of the sleeve base 21. The second penetration body segment 82' is designed similarly to the second penetration body segment 82 of the first variant of the medical instrument 100 according to the solution, 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 edge 823'.

[0076] In the axially nested 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.

[0077] The embodiment illustrated in Figure 9 shows a longitudinal section comparable to Figure 8, but in this case a hollow channel 13' also leads through the central single shaft 3', e.g. for the passage of a guide wire 14.

[0078] Figures 10a to e represent sequence images to illustrate the production of a

[0079] The instrument represents an opening within an organ wall, preferably a heart wall 15. In Figure 10a, the medical instrument 100' is oriented externally towards the apex HS of the heart. A guide wire 14 is inserted through the heart wall 15 by a suitable puncture, though not necessarily. The medical instrument 100' is positioned along the guide wire 14 relative to the apex HS on the heart wall 15, 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 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 shaft longitudinal axis A.

[0080] 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 (Figure 10b).

[0081] 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 inward advance of the first penetrating body segment 81' relative to the heart wall 15.For the purpose of widening the initial opening 16 within the heart wall 15, the second penetration body segment 82' is pierced through the initial opening 16 in a subsequent penetration process, causing elastic radial expansion of the cardiac muscle tissue immediately adjacent to the opening 16. After complete joint penetration of the penetration body segments 81' and 82', as shown in Figure 10d, this tissue elastically regresses radially (Figure 10d). The shape and size of the second penetration body segment 82' are selected such that the cardiac muscle tissue adjacent to the opening 16 does not suffer any traumatic injury during the penetration process. In particular, uncontrolled tissue tears during the penetration process must be avoided.

[0082] 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 heart wall 15. The tissue portion separated from the heart wall 15 by the incision is transferred and remains safely contained in the second cavity 8221' of the second penetrating body segment 82'.

[0083] Both variants for forming the 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 transection of the heart wall. Reference list

[0084] A shaft longitudinal axis

[0085] HS Heart apex

[0086] 1 instrument housing

[0087] 2 shaft arrangement

[0088] 3.3' Single unit

[0089] 4.4' Single shaft

[0090] 5 Actuators

[0091] 6 shoring devices

[0092] 7 Fixing element

[0093] 8 Penetrating bodies

[0094] 81, 81' first penetration body segment

[0095] 811 first body section of the first penetrating body segment

[0096] 812 second body section of the first penetrating body segment

[0097] 8121 first cavity

[0098] 813 Cutting blade

[0099] 82, 82' second penetration body segments

[0100] 821 , 821 ' first body section of the second penetrating body segment

[0101] 822, 822' second body section of the second penetration body segment

[0102] 8221 , 8221 ' second cavity

[0103] 823, 823' cutting blade

[0104] 83 third displacement body segment

[0105] 831 first body section of the third displacement body segment

[0106] 832 second body section of the third displacement body segment

[0107] 8321 third cavity

[0108] 833 Cutting blade

[0109] 84, 843, 84' recess

[0110] 9 top

[0111] 10 first conically tapering body section

[0112] 11 second cylindrical body section distal recess

[0113] Hollow channel

[0114] guide wire

[0115] Organ wall, heart wall, vessel wall, initial opening, widened opening, tubular single shaft

[0116] Cutting blade first cavity

[0117] shell base

[0118] Fixing element medical instrument

Claims

Patent 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 assembly (2) having a shaft longitudinal axis (A), the penetration body comprising a first body section (10) and a second body section (11) adjoining the first body section (10) proximally, the latter at least partially delimiting a cavity radially to the shaft longitudinal axis and having a cutting blade radially enclosing the cavity proximally, characterized in that the penetration body (8) is composed of at least one first and one second penetration body segment (81, 82) which are mounted axially one behind the other and separately from each other in a bidirectionally deflectable manner along the shaft assembly (2) and each have a first body section (811, 821) tapering distally in cross-section and a second body section (812, 822),that the first body section (811) of the first penetration body segment (81) terminates distally, forming a tip (9), and that 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) facing axially towards the first penetration body segment (81), 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 delimits 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 producing an opening (17) in a vessel or organ wall (15) with a penetration body (8) attached distally to a shaft assembly (2) having a shaft longitudinal axis (A), the penetration body comprising a first body section (10) and a second body section (11) adjoining the first body section (10) proximally, the latter at least partially delimiting a cavity radially to the shaft longitudinal axis and having a cutting blade radially enclosing the cavity proximally, characterized in that the penetration body (8) is composed of at least one first and one second penetration body segment (81', 82') which are mounted separately and bidirectionally deflectable from one another along the shaft assembly (2), and that the first penetration body segment (81') is designed in the manner of a cutting sleeve.the distal side has a circumferential cutting blade (19) and radially limits a distally open first cavity (20), and that the second penetration body segment (82') has a first body section (821') tapering distally in cross-section, which has a recess (84') oriented axially towards the distal side of the first penetration body segment (81') into which the first penetration body segment (81') can be inserted at least partially, and a second body section (822') which radially limits a second cavity (8221') at least partially and has a cutting blade (823') radially enclosing the second cavity (8221') proximally.

3. Medical instrument according to claim 1 or 2, characterized in 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 in that the at least two individual shafts (3, 3', 4, 4'), of which at least one individual shaft is tubular, are arranged coaxially to each other.

5. Medical instrument according to one of claims 1 to 4, characterized in that the at least two penetration body segments (81 , 81 ', 82, 82') are axially or rotationally symmetric about the shaft longitudinal axis (A).

6. Medical instrument according to one of claims 1, 3 to 5, characterized in that the recess (84) of the second penetration body segment (82) is dimensioned in shape and size to completely accommodate the second body section (812) of the first penetration body segment (81).

7. Medical instrument according to one of claims 1, 3 to 6, characterized in that the first body section (811) of the first penetrating body segment (81) has a hollow channel (13) extending through the tip (9).

8. Medical instrument according to claim 7, characterized in that the hollow channel (13) is dimensioned, designed and arranged to be suitable for the passage of a guide wire (14), for aspiration, for the injection of a gas or liquid or for the passage of a catheter.

9. Medical instrument according to one of claims 1, 3 to 8, characterized in 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 are in an axially interlocked state of the first and second penetration body segments (81 , 82) form a uniformly connected surface in the manner of a straight cone.

10. Medical instrument according to one of claims 1, 3 to 9, characterized in 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 deflectable bidirectionally, 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) distally, 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) proximally.which at least partially has a second cavity (8321) radially limited and a cutting blade (833) radially enclosing the second cavity (8321) on the proximal side.

11. Medical instrument according to one of claims 2, 3 to 5, characterized in that a fixing element (22) is arranged within the first cavity (20) 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 in that the fixing element (22) is helical and / or in the form of a barb.

Images