DE2927143A1 - SURGICAL INSTRUMENT, IN PARTICULAR TO TAKE ON HEART PACEMAKERS - Google Patents

Description

DR. -ING. OlPL.-INa.iCSC. - - - - OrPL. -f-tira.OR ·. _ OIPL.-PHYS. PIPL.-PHYS. DH.

HÖGER - STELLFiECRJ -r ^ RiES ^ ßAlCH - HAECKER BOEHME

PATENT LAWYERS IN STUTTGa'rT

A 43 527 b Applicant: Cordis Corporation

k - 177 3901 Biscayne Blvd.

July 4, 1979 Miami, Florida 33 137

S. ^ÜSA

description

Surgical instrument, in particular for sewing on cardiac pacemakers

The invention relates to a surgical instrument for forming suture elements in the form of a closed, preferably circular loop in inaccessible tissue areas, especially an instrument for sewing on pacemakers .

So far it is common to have pacemaker electrodes on the heart either suturing in the usual way, which is a thoracotomy. required to expose the heart, or special Electrodes to use their own fixtures and which are usually introduced into the heart through a vein. However, both solutions have their drawbacks. A thoracotomy results in a large rib cage where at least one rib must be cut Surgical wound, so the entire operation is associated with high risks. With pacemaker electrodes with own fastening or anchoring devices, as described, for example, in US Pat. No. 4,000,745, where a screwdriver-shaped anchoring element is provided, lead in the heart muscles where the electrical Stimulation is supposed to result in injuries that result in the formation of scar tissue. But there is scar tissue is a poor electrical conductor, a higher current is required to adequately stimulate the heart, whereby

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the current level required for stimulation can also change over time. Furthermore describes the U.S. Patent 4,066,085 discloses a resilient epicardial electrode with claw-like attachment hooks which are separated from a electrical stimulation winding are provided. With this electrode, the wound is at the point of stimulation very low; on the other hand, it must be attached directly using pliers or the like. Also for this Major operations are again required to perform the implantation. The üS-PSs 3 754 555, 3 902 and 3 814 104 describe endocardial to be introduced via the veins Electrodes that, once positioned inside the heart, have hooks, thorns, or claws released to set the electrode.

In general, various surgical instruments have been developed which facilitate the suturing of tissue in hard-to-reach places Make places easier. For example, US Pat. No. 1,822,330 describes an instrument with the aid of which Tonsilectromy sutures are placed in the oral cavity. In doing so, the instrument is inserted through a natural body opening (Mouth) inserted and can be observed immediately. Changing "sewing" instruments connect easily accessible ones Tissue parts using pre-formed metal clips or clips, as shown in U.S. Patents 715,612, 2,881,762, and 3,098,232 is described. However, it is not possible with any of these known instruments to produce suture elements in a tissue, which can neither be reached nor seen through a natural body opening, nor after exposure of the tissue accessible through surgery. Furthermore, none of the known instruments is suitable, a pacemaker electrode to hold, position and sew with the heart, especially if the suture elements fit the shape

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should have closed loops and at a distance of Stimulation points must be attached.

Based on the prior art, the invention is based on the object the basis of specifying an improved surgical instrument that can also be used in areas of tissue that are difficult to access Seam elements are formed in the form of closed loops can and with which it is particularly possible, a pacemaker electrode securely sutured or sutured to a patient's heart without performing a thoracotomy and thereby the injury to the heart tissue at the point of stimulation to a minimum.

The aim here is also to be able to use the instrument to form suture elements in generally inaccessible tissue areas that are not directly visible are.

This task is performed with a surgical instrument of the initially described type solved according to the invention in that an elongated base body with at least one Guide is provided in which a deformable sewing element with one for the formation of a closed loop with a given radius of curvature of sufficient length in the axial direction essentially free of play, slidably displaceable is and from the sewing element by means of feed devices e is pushable, and that the guide deflection devices are assigned, with the help of which the sewing element is permanently deformable in the course of its feed movement in such a way that its part which has emerged from the deflection devices is curved at least substantially with the predetermined radius of curvature is. ''. '

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It is particularly advantageous if the instrument according to the invention in an embodiment of the invention is designed so that several loop-shaped seam elements are formed at the same time can be.

It is also favorable if the instrument in an embodiment of the invention is designed in such a way that it can be brought up to the patient a pacemaker electrode can serve to the heart, that it enables the suturing of the electrode to the heart and that after the electrode has been sewn on, it can be detached one after the other from this and the associated supply line.

In all of this, the instrument according to the invention is, for the sake of simplicity, hereinafter referred to as a sewing tool is reliable and easy to use and is relatively simple and inexpensive to set up.

In a preferred embodiment of an instrument according to the invention for producing at least one suture element in the form of a closed loop - in the following, for the sake of simplicity, we will only speak of a seam, which is formed by the use of sewing elements - an elongated base body is provided, which at its one End of a handle and an actuating element in the form of a Has ram. The other end of the instrument is designed in such a way that it has an epicardial pacemaker electrode can detachably hold. In the main body of the instrument there is also at least one tubular guide element an inner bore is provided in which an associated deformable sewing element can be guided with almost no play. That The end of the tubular element is curved adjacent to the holding devices for the electrode in such a way that the sewing element, when it is advanced or ejected from the inner bore, beyond the limit of its elastic

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Deformability is also deformed, so that a permanent curvature of the sewing element with a substantially predetermined Radius of curvature results. The plunger (with a molded arm) and a sliding wire in the inner bore of the In this instrument, tubular elements drive the suturing element through the bore and through it as a deflection device serving curved end therethrough. In this way the sewing element becomes a substantially closed circular one Loop shaped. The suture elements created in this way (at least one) penetrate the heart tissue adjacent to the stimulation point of the electrode and hold the electrode in secure electrical connection with the heart tissue.

In a particularly preferred embodiment of an instrument according to the invention, there are two tubular guide elements provided in operation on opposite sides the actual stimulation electrode of the electrode arrangement and each inserting a sewing element can be. In this case, a recess is provided on the electrode-side end of the instrument, which is suitable for a elastically deformable projection on the back of the electrode to record. When the electrode is attached to the Instrument is attached, this can be used to bring the electrode into the correct position on the heart muscle. The end of the instrument on the electrode side is preferably provided with an inclined surface, so that the electrode has an inclined position with respect to the longitudinal axis of the main body of the instrument, which makes aligning and attaching the electrode easier " the main body of the instrument is preferably designed to be relatively flat, so that it can easily be found under the costal arches the patient's canoe can be pushed through.

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In a preferred embodiment of an inventive Instrument there is also the possibility to clamp the electrical lead of the pacemaker electrode, so that it cannot interfere with the insertion and sewing of the electrode. When using such an instrument the electrode is in the correct position in relation to the heart, then the piston moves forward when traversing a first section, initially to expel the suturing elements which penetrate the heart tissue and forming closed loops to secure the electrode to the heart. Another forward movement of the The plunger and the resulting axial displacement of a separating rod then lead to the elastic projection the electrode is pushed out of the recess of the instrument so that the electrode is removed from the instrument is resolved. The forward movement of the separating rod also separates the in a slot on the underside of the instrument clamped lead from the instrument. Part of the Slot preferably formed by a recess in the separating rod, the inclined surface at the rear end the recess is provided.

Further details and advantages of the invention are provided below explained in more detail with reference to drawings and / or are the subject of subclaims.

1 shows a plan view of an instrument or suturing tool according to the invention for attaching an epicardial Pacemaker electrode on a patient's heart;

FIG. 2 shows a side view of the sewing tool according to FIG. 1 with an electrode held thereon;

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3 shows an enlarged longitudinal section through the sewing tool T along the line 3-3 in this figure;

Fig. 4 is a bottom view of the portion shown in Fig. 3, with some parts broken off ·?

FIG. 5 shows a cross section through the sewing tool according to FIG. 2 along the line 5-5 in this figure;

6 shows a longitudinal section through the sewing tool according to FIG. 1 along the line 6-6 in this figure; : ■ '/, - "■

Fig. 7 is a longitudinal section along the line 7-7 in Fig. 6;

FIG. 8 is an end view of the head part shown in FIG. 7 of the sewing tool;

Figure 9 is a cross-sectional view taken along line 9-9 in Figure 6;

10 shows a detailed side view of a guide element a sewing tool according to the invention for explanation the deformation of the sewing elements;

11 shows a side view of an electrode that can be attached using a sewing tool according to the invention, and FIG

Fig. 12 is a plan view of the in use the heart of the Patent facing side of the electrode according to Fig. 11.

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1 and 2 of the drawing show in detail a surgical one Suturing tool 12 according to the invention, which is particularly suitable, having an epicardial pacemaker electrode 18 suturing to a patient's heart. The sewing tool 12 has a substantially elongated base body 14, the preferably made of a rigid injection-molded plastic material such as. B. consists of a polycarbonate. At one end 12a of the Basic body 14, a type of pistol grip 16 is provided, on which the surgeon can comfortably grip the sewing tool while sewing, can guide and operate easily. The other end or the head 12b of the sewing tool 12 is suitable, the electrode to hold and guide them to the desired attachment point on the heart. A manually operable plunger 20 is slidably displaceable in the axial direction in a recess 22 of the handle 16. The plunger is between a rest position and a front end position reciprocable. During a first part of its forward movement (in Fig. 1 and 2 to the right) the plunger 20 sutures the electrode 18 to the heart. During a second part of its forward movement The ram 20 releases the electrode 13 and its supply line 40 from the sewing tool 12.

The ram 20 has two arms 24 as extensions, which are guided in the axial direction in channels 26 of the sewing tool 12 are. The channels 26 have a circular cross section and extend from the handle 16 over the entire length of the base body 14 up to an end face 12c. The wall of the channels 26 can be made up of pipes stainless steel, such as those used for hollow needles. The channels 26 are used for the exact guidance of the Arms 24 and the guide of advancing wires 28 and sewing elements 30. The wires 28 are relatively stiff and consist preferably made of stainless steel with a diameter

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knife of about 0.25 mm. The sewing elements 30 are made of suitable ones malleable material in which deformation remains when it exceeds its elastic stretchability is deformed. Preferably for the sewing elements 30 a semi-hard Elgiloy alloy used. Each of the arms 24 has an advance wire 28 and a sewing element 30 assigned in alignment. The elements mentioned are supported at the end of each other, so that a forward movement of the plunger 20 from its rest position into a corresponding Forward movement of the associated wire 28 and the associated sewing element 30 in.dem enclosing the elements Channel 26 is implemented. As specifically shown in Figures 6-10, the forward ends 26a of the channels 26 are in the head 12b of the sewing tool 12 curved in such a way that the sewing elements 30 emerge from the channels 26 along an arcuate path 31, the curvature of which is determined by the curvature of the channel ends 26a. The curvature of the channel ends 26a is selected so that the sewing elements 30 when the ram is advanced first penetrate the heart tissue at a point 32 (Fig. 6), then reach a point 34 and finally reach through the grooves 36 (FIGS. 6 and 12) of the electrode 18. the Sewing elements 30 are of sufficient length to be circular Form a closed loop seam so that the electrode 18 is securely attached to the heart, with a protruding electrical stimulation electrode 38 of the Electrode 18 penetrates the heart tissue. The stimulation electrode 38 is designed in the usual way and has a cutting element 38a and a conductor 38b wound into a helix, which supports the cutting element 38a and an electrical cardiac stimulation signal from a pacemaker (not shown) to the heart muscle. The inverted conductor 38b is over a lead 40 is connected to the pacemaker. A major advantage of the sewing tool described above is

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it says that the injuries caused by sewing are at a distance from the point where the electrical Stimulation takes place. Another advantage is that the two are preferably in the form of closed loops having sutures, attach the electrode to the heart with great reliability.

When working with the sewing tool according to the invention, the electrode 18 is first on the inclined end face 12c of the head 12b. The sewing tool is therefore not only advantageous when sewing on, but also serves to protect the electrode to the right place in the heart, whereby the The tool or the electrode is usually introduced starting from an incision in the abdominal wall where the pacemaker is located is attached, takes place under the costal arches. As is particularly clear from the cross-sections according to FIGS. 5 and 9 is, the base body 14 of the sewing tool 12 according to the invention is more wide than high, so that it is under the costal arches can be pushed through. The head 12b and the electrode 18, which lie flat on the end face 12c of the head 12 is supported are inclined downward in use such that the electrode 18 is substantially at the implantation site is supported on the adjacent heart tissue. The inclination of the end face 12c further leads to a flattening of the supply line 40, which extends from the lower end of the electrode 18, which further simplifies the insertion of the electrode will. The handle 16 ultimately takes a grip on the patient's body as the suturing tool is used flat position, so that he can insert the electrode 18 as possible little handicapped.

Looking specifically at FIGS. 7 and 11, it can be seen that the electrode 18 has an elastic projection 42 with an im

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has substantially cylindrical bead 42a, which is received by a substantially cylindrical recess 44 in the head 12b of the sewing tool 12. The electrode 18 is attached to the sewing tool 12 by pressing the projection 42 into the narrowed front end 46a of a central channel 46 of the base body 14 until the bead 42a is seated in the recess. A separating element or rod 48, which is preferably injection-molded from a rigid plastic material, is slidably guided in the central channel 46, which extends from the recess 22 in the handle 16 "to the end face 12c of the head 12b. As in FIG. 1 1 and 2, the rear end 48a of the rod 48 can be gripped by the plunger 20 as it moves forward when it is seated in the recess 44. During the first part of the advancing movement of the ram 20 from its rest position, the latter acts via its arms 24 and the wires on the sewing elements 30, which are advanced and formed into closed loops. Towards the end of the second part The forward movement of the plunger 20 pushes the rod 48 the projection 42 out of the recess 44, whereby the electrode is released from the tool 12. During this l In addition, the final ejection of the sewing elements is ended in the last phase of the feed movement. In Fig. 3, the rest position of the rod 48 is shown in solid lines, while its front end position is shown with dash-dotted lines . . ■ ■ '-

As shown in FIGS. 2 to 4, the rod 48 also serves to the lead 40, which is partially in a slot 50 is set, on the one hand through an opening 52 in the Underside of the base body 14 and on the other hand by an outlet

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Savings 54 of the rod 48 is limited by the tool. 12 to solve. When the plunger 20 is in its rest position, The position of the recess 54 coincides with that of the opening 52. A portion of the slot 50 thus formed is formed 40a (FIGS. 2 and 5) of the supply line 40 were added. the Side walls 52a of the opening 52 open, as is best shown in FIG. 5, in the shape of a funnel outwards, so that the insertion of the lead 40 is facilitated, the lead 40 when fully inserted into the slot is, on the other hand, held behind the narrowest point of the slot defined by the side walls 52a. on This way the lead is held firmly in place when the electrode is inserted, so that the probability of the insertion of the electrode 18 and the sewing of the same are hindered by the lead, is reduced to a minimum. When the electrode has been sewn on, however, an inclined surface occurs during the advancing movement of the rod 48 56 at the rear end of the recess 54 in contact with the supply line 40 and pushes it outwards out of the slot out. In this way, the supply line 40 is detached from the sewing tool 12, immediately before the electrode 18 from the sewing tool 12 is released.

In preparing the sewing tool 12 for insertion and sewing on an electrode 18, the plunger 20 is first removed from the recess 22, whereupon, proceeding From the recess 22, first a sewing element 30 and then a wire 28 are inserted into each of the channels 26. In addition, the rod 48 is pushed into the central channel 46, that its recess 54 is aligned with the opening 52 on the underside of the base body 14. Now the The plunger 20 is reinserted into the recess 22 with its arms 24. Finally, on the head 12b, the electrode becomes

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attached. In addition, the section 40a of the supply line is clamped in the slot 50. The sewing tool is now ready to use. . .-; '

Starting from a small incision below the costal arches, the front part of the sewing tool 12 is now with the Electrode 18 inserted into the patient's chest cavity, wherein the position of the electrode in relation to the heart by the Mediastinosköpie procedure is controlled. If the Electrode is then in the correct position, the Push the plunger forward. In the process, the sewing elements 30 are first pushed out and now form closed seams or loops that fix the electrode 18 permanently to the heart. During the last part of the feed movement, the electrode 18 and its supply line are then with the help of the rod 48 40 detached from the sewing tool 12. The sewing tool is then withdrawn from the chest while the electrode 18 remains at heart. Before the electrode 18 is finally attached to the heart, the suturing tool can be attached to it First use the attached electrode to check the sensitivity of the areas intended for the attachment of the electrode check of the heart. This is more beneficial than a corresponding check with a special test probe, as it is often difficult when working with a test probe, to find the same point when attaching the electrode.

From the above description it is clear that the inventive Sewing tool is ideal for attaching epicardial pacemaker electrodes, whereby Eliminates the need to operate the heart directly through to expose the opening of the chest cavity with a transection of the ribs, which is far more dangerous than making a small incision underneath

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the costal arches. In addition, according to the invention, the electrode fixed on the heart with sutures or suturing elements that are at a distance from the stimulation electrode 38, whereby the injury to the heart muscle in the area of the impulse is reduced to a minimum. Here is the inventive Sewing tool set up simply and cheaply.

Although the sewing tool described above according to the invention is particularly suitable for attaching an epicardial pacemaker electrode to the heart, it understands that the sewing tool can also be used with advantage in other operations or the like, where it is on is important to attach sewing elements in the form of closed loops in poorly accessible places. For example, a Tissue tears can be sewn without the need to completely expose the injury site, as is the case with the usual Sewing process is the case. Furthermore, there is the possibility of designing the sewing tool according to the invention in such a way that that sewing is carried out with only one sewing element or with more than two sewing elements.

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Claims (1)

DR.-ING. OIPL.-INS. CJT. SC. """." *. "* 07PL ₁ -PPl VS-CFT. DIPL.-PHYS. HÖGER - LEGAL RIGHT-GRIES ^ BACH - HAECKER DIPU-PHYS. I ». BOEHME PATENT LAWYERS IN STUTTSART A 43 527 b Applicant: Cordis Corporation k- 177 r 3901 Biscayne Blvd. July 4, 1979 Miami, Florida 33 137 United States Claims Surgical instrument for forming suture elements in the form of a closed, preferably circular, Loop in poorly accessible tissue areas, characterized in that an elongated base body (14) is provided with at least one guide (26) in which a deformable sewing element (30) with a for the formation of a closed loop with a given radius of curvature sufficient length in the axial direction Direction is essentially free of play, slidably guided and from your sewing element (30) by means Feed devices (20, .24, 28) can be ejected, and that deflection devices (26a) are assigned to the guide (26), with the aid of which the sewing element (30). remaining like this in the course of its advance movement What is deformable is that its part which has emerged from the deflection devices (26a) at least substantially with it the given radius of curvature is curved. 2. Instrument according to claim 1, characterized in that the feed devices (20, 24, 28) have a plunger (20) which is slidable in the axial direction in the base body (14), and that connecting elements (24 , 28) are provided , via which an operative connection between the ram (20) and the sewing element (30) can be established. 3. Instrument according to claim 2, characterized in that the connecting elements have one in the guide (26) 909804/0750 A 43 527 b - k - 177::: .. July 4, 1979 ■ ... - Page 2 - guided, between the ram (20) and the sewing element (30) have arranged advance wire (28). 4. Instrument according to claim 1, characterized in that the deflection devices are formed by a curved end region of the guide (26). 5. Instrument according to one of claims 1 to 4 for attaching an epicardial pacemaker electrode, thereby characterized in that holding means (44, 46a) for holding the electrode (18) at one end of the Base body (14) are provided and that separating devices for releasing the electrode (18) from the holding devices (44, 46a) after it has been completely ejected of the sewing element (30) are provided. 6. Instrument according to one of claims 1 to 5, characterized in that that the guide is designed as a tubular element (26) fixed in the base body. 7. Instrument according to claim 5 or 6 for fastening electrodes with an electrical lead, characterized characterized in that securing devices (50) for releasably securing one at a distance from the electrode (18) located portion (40a) of the supply line (40) of the same are provided. 8. Instrument according to claim 5 and 7, characterized in that the separating devices (48) with devices (54, 56) are provided for releasing the secured section (40a) from the securing devices (50). 909884/0750 July 4, 1979 '^; --- 'page 3.r 3 2927U3 9. Instrument according to claim 6, characterized in that the deflection devices are formed by a curved section (26a) of the tubular element (26) are formed adjacent to one end of the base body (14). 10. Instrument according to one of claims 5 to 9, characterized in that that the holding devices (44, 46a) have a recess (44) for releasably securing an elastically deformable connecting piece (42) of the electrode (18). 11. Instrument according to claim 10, characterized in that the separating devices in the base body (14) in separating element (48) slidable in the axial direction for establishing an operative connection between the plunger (20) and the elastically deformable connecting piece (42). 12. Instrument according to claim 10, characterized in that the operative connection between the plunger (20) and the separating element (48) is only present towards the end of the ejection of the sewing element (30). 13. Instrument according to claim 7 and 11, characterized in that that the safety devices (50) through an opening (52) in the base body (14) and one with it in its starting position the plunger (20) aligned recess (54) of the separating element (48) are formed. 14. Instrument according to claim 1,3, characterized in that the recess (54) has an inclined surface (56) through the supply line (40) from the recess (54) and the opening (52) when the separating element (48) is moved in the 909884/0750 A 43 527 b k - 177. ··. ·· ■ "■■ ·: --ν
July 4, 1979 :: - · -. _ 3page 4- direction on the one provided with the deflection devices (26a) The end of the base body (14) can be moved out. 15. Instrument according to one of claims 1 to 14 for forming two each in the form of a closed, preferably circular, loop on v / iron suture elements for attaching an epicardial pacemaker electrode provided with a lead with a stimulation point located at a distance from the sewing elements, characterized in that two tubular guide elements are provided in the elongated base body (14), which extend essentially along the longitudinal axis of the base body (14) and in each of which a deformable sewing element (30) can be guided and which allows the sewing elements (30) to be pushed out ) serving end regions (26a) are curved in such a way that the sewing elements, exceeding their elastic deformability, can be bent essentially with the predetermined radius of curvature SiHd ₇ and that the feed devices have a ram (20) and a pushable wire (28) in each of the guide elements (26) exhibit. 909834/0750