DE2929233A1 - DEVICE FOR FORMING A TISSUE TUNNEL AND / OR FOR POSITIONING A PIPE IN BODY TISSUE - Google Patents

Description

P - 300

MEDTRONIC, INC.

3055 Old Highway Eight, Minneapolis, Minn. 55440, V.St.A.

Device for forming a tissue tunnel and / or for positioning a line in Body tissue

The invention relates to a device for forming a tissue tunnel and / or for positioning a line in it Body tissue.

Modern implantation techniques for body stimulators (electrical stimulation devices) often mean that the stimulator components (signal generator, electrode, receiver and the like) be arranged in separate, distant locations. One line provides an electrical one Link between the bodies concerned. The line is laid subcutaneously so that it is not exposed.

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One formed between the implantation points of the components or the component point and a line exit point Incision would allow subcutaneous placement of the lead. However, it represents a common one medical practice to minimize penetration into the body. As a result, other techniques were used for the developed subcutaneous routing of the line. Typically, tools are used that allow a tunnel to train that leads from one point to the other.

It is known to use a hypodermic needle for tunnel formation large enough to allow the conduit to pass through; the injection needle is attached to one Place inserted and guided towards the other place, creating a tunnel. However, such a needle is rigid; it cannot adapt to the body contour between the relevant points. As a result, the Risk of the rigid needle penetrating too deeply and passing through muscle tissue. Piercing a muscle leads to the formation of unwanted scar tissue and excessive bleeding. It can also cause muscle contractions to cause one Break in the line. Cost factors also make it often it is necessary to use a needle that is not long enough to reach from one point to the other. Therefore different tunnels have to be formed in order to bridge the distance between the relevant points.

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Many known lines are equipped with a connection unit to connect them to the signal generator, receiver for the
To connect recording of external signals and / or large electrode arrangements. Such pipe components are, in
usually too large to be passed through an injection needle of the type described above. As a result, only the end of a lead that does not have a large lead component can pass through the needle
will. The device parts that are necessary to the
Connect a hypodermic needle to a hypodermic syringe,
also allow the needle to be withdrawn from the tissue
only one way. This fact often complicates the formation of a tunnel using a hypodermic needle, because the line must be passed through the needle from the end opposite the connection parts in order to be able to pull the needle out over the line; in particular, it is determined at which point the needle is inserted
must become.

Other tunneling methods have used a subcutaneously laid tube to create and maintain a tunnel between the desired sites. In the case of the corresponding known devices, these tubes represent part of the finished implant. They must therefore be made of a material that is compatible with the body, for example silicone or
a urethane. Such pipes lead to

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Advantages over the injection needle discussed above, because the line can be used from one end or the other; the need for the material Selecting for the pipe in view of its usability as an implant, however, complicates the laying. In other words, the pipe's characteristics must be tailored to the environment in which it is located, instead of being easy to lay of the pipe. The properties of certain pipe materials can hinder the laying.

The aim of the invention is to remedy the deficiencies outlined above will. In particular, the invention is based on the object of providing a device for forming a tissue tunnel and / or to provide body tissue for positioning a conduit in body tissue that is adaptable to the body contour easily penetrates and minimizes the risk of muscle tissue puncture.

This object is achieved by the measures characterized in the claims.

According to a preferred embodiment of the invention is an elongated shaft made of a material that can be adapted to the body contour at one end with a tissue-penetrating shaft Tip provided. A tube sits on the shaft which, together with the shaft, can be adapted to the body contour.

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Preferably, the tube is made of a low friction material to allow the tube to slide through body tissue to facilitate; there is also a handle for manipulating the shaft.

If a subcutaneous tunnel is to be formed and maintained from a first location to a second location, the combination of shaft and tube is adapted to the body contour between these points. An incision can be made on both Bodies are executed. Alternatively, it is also possible to make an incision at one point for the arrangement of a component and insert the shaft at the other site percutaneously in the direction of the desired component site. in the one as in the other case, the point on the shaft penetrates the tissue, so that the shaft of the one can be moved to the other location. The low friction tube facilitates the passage of the shaft through the tissue. When the tip arrives at the desired location, the shaft is pulled out of the tube. The pipe remains in place and place to maintain the tunnel formed by the tip. According to a preferred embodiment, the shaft is provided with a stop which is against creates the pipe so that it is carried along by the shaft. The tip can advantageously have three facets, the facilitate the penetration of the tissue. After the shaft has been pulled out, a line can be drawn from one or the other

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Ren end of the tube are introduced. The tube is then pulled out of the body tissue. Because the pipe doesn't remains in the body, it can be made of an inexpensive material so that a tool of sufficient length can be manufactured without undue cost. Unlike the hypodermic needle, the tube can be used either by one or by the other pulled out from the other point, which greatly simplifies the entire procedure.

However, the embodiment explained above is unsuitable for lines with a large component at both ends of the line. In such a case a Pipe of sufficient size can be used to, for example, the passage of a connection unit or a large To allow electrode arrangement. This can prove impractical. According to a modified embodiment of the device according to the invention is therefore an elongated one Shank, preferably made of a material that can be adapted to a body contour, is present on the one End carries a body tissue penetrating tip. The tip is inserted into the body tissue at a predetermined location inserted and guided in the direction of another point by manipulating the shaft so that between the two points a tunnel is created. The shaft is provided with a device or tool that engages the conduit and brings the line into the tunnel when the shaft is out of the

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Body tissue is pulled out. According to an advantageous further development, the tip and the tool are on Replaceably mounted at the same end of the shaft. According to a modified embodiment, the tip and the Tool can also be mounted on opposite ends of the shaft. The shaft is provided with a handle to his Simplify handling. The part of the line that does the Tool comes into engagement is at or adjacent to the end of the line. When the stem is pulled out, it passes through the tool the tunnel; the tool pulls the line into the tunnel. In cases where the management has a has large component at one or both ends, the tool can be designed to work with that component comes into engagement. According to a preferred embodiment, the tool is designed in the form of a connection housing, which receives a line connection unit and pulls the connection unit and the line through the tunnel, if the shaft is pulled out. The tip piercing the tissue preferably has a cross section that is greater than the cross-section of the shaft is such that a tunnel of sufficient size is created for the passage of the terminal unit without causing a tight fit between the tunnel and the shaft. The tool can also be equipped with means for separating the tissue in order to provide for a further enlargement of the tunnel and / or facilitate movement of the tool through the tunnel.

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The invention is described below on the basis of preferred exemplary embodiments explained in more detail. In the accompanying drawings show:

Fig. 1 is a view of a preferred embodiment

shape of the device according to the invention,

Figure 2 is a view of the tip of the device

according to Fig. 1,

Fig. 3 is an exploded view of a wan

3rd embodiment of the invention,

Fig. 4 is a partially sectioned view of the

Tip of the device according to Fig. 3,

Fig. 5 is a section along line 5-5 of

Fig. 3 together with the connection unit of a line,

6 shows the handling of the tip of the device

according to FIGS. 3 and 4,

7 shows the handling of the driver of the device

tion according to FIGS. 3 and 5,

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8 shows the subcutaneously laid line,

9 shows a modification of the embodiment according to

Fig. 3 and

Fig.IO a further modified embodiment

form of the device according to the invention.

The illustrated in Fig. 1 device has an elongated Shank 1, at one end of which a tip 2 intended to penetrate tissue is arranged. The shaft can be made of any material that can be sterilized and bent to adapt to a body contour, for example made of aluminum or stainless steel. The shaft 1 is equipped with a handle 3, by means of which the shaft 1 is handled when penetrating tissue and when pulling it out. The handle 3 is in one piece with the shaft 1 connected and offset from the longitudinal axis of the shaft 1 in one direction. Other configurations of the Grj-ffs can be provided, wherein the handle can be connected to the shaft in one piece or in some other way. A handle at least a part of which is offset in one direction with respect to the longitudinal axis of the shaft, however, allows the Device particularly convenient to use without the handle interfering with the body. For example, can a corresponding approach can be used to

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by means of a push or pull force or a combination to use both forces. The shaft can be oriented in the body tissue so that the recessed part of the handle stands away from the body. In this way, the handle can be easily grasped and handled.

The shaft 1 is inserted into a tube 4 made of a low friction material to facilitate the movement of the device through body tissue. A preferred material for the pipe 4 is polytetrafluoroethylene. In the present case, facilitating the movement of the shaft through the body tissue is to be understood as meaning that the combination of shaft and tube can be moved through body tissue more easily than the shaft alone. A stop 5 is provided on the shaft 1 in order to prevent the tube 4 from moving past the stop 5, so that the tube 4 is carried along by the shaft 1 in a controlled position. The stop can be connected to the shaft in a known manner by crimping or folding. The tip 2 is formed in a known manner; according to FIG. 2, it has three facets 6 to 8.

When using the device, the shaft 1 is inserted into the tube 4 until the tube 4 hits the stop 5. the Locations between which a subcutaneous tunnel is to be formed and maintained are determined. In both places an incision can be made; the combination of

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The shaft and tube are then inserted at one point and guided subcutaneously in the direction of the other site. According to a modified type of handling, an incision can be made run in one place; the combination of shaft and tube can then be percutaneously at the other site used and guided towards the first place. The stop 5 holds the tube 4 during insertion on the shaft 1 in a predetermined position.

After the tunnel by inserting the arrangement according to FIG is formed in the body tissue, the shaft 1 is pulled out while the tube 4 remains in place, to keep the tunnel going. The low friction of the Tube 4 facilitates the extraction of the shaft 1 and the insertion of the shaft to form the combination according to FIG Fig. 1. The tube 4 can be pulled out from one point or the other. This allows the line from inserting one or the other end, a choice that is often not necessary with the hypodermic needles discussed above Available. However, if the conduit has a component too large to go through the pipe ~ 4, it must other end of the line through the pipe 4 through from the Component point are used from. But also in this one

i.

In this case, the device according to FIG. 1 can be introduced at one point or the other. After the line through the pipe 4 is moved through, the pipe 4 is pulled out,

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while the lead remains subcutaneous.

The possibility of adapting the shaft 1 (and the tube 4 together with the shaft 1) to a body contour allows a Create subcutaneous tunnels with minimal muscle tissue penetration. The shaft and the tube can be made from inexpensive Materials to be made so that the shaft and tube can be made long enough to cover the distance between to bridge the affected places with a single tunnel. The material of the pipe 4 is also chosen so that that the combination according to FIG. 1 can easily be pushed through body tissue. Handle and tip can be in other than the illustrated manner. Any material other than those mentioned above can be used Requirements met. The length and diameter of the shaft and tube depend on the particular application.

Fig. 3 shows a modified embodiment with an elongated one Shank 10 and tools 11 and 12 interacting therewith. One end of shank 10 has a handle 13 while the tools 11 and 12 are mounted at the other end can be. Preferably, the shaft is threaded at its end 14, while the tools 11 and 12 Have threaded bores 15 and 16, which are connected to allow the threaded end 14 to connect the tool in question to the shaft 10. The shaft 10 can

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in this case also consist of any sterilizable material. Again, a material is preferred chosen that allows an adaptation of the shaft to a body contour, for example aluminum or stainless steel. Of the Handle 13 is integrally connected to shaft 10 and offset in one direction with respect to the longitudinal axis of shaft 10, as is explained in more detail in connection with FIG.

The tool 11 is a tip suitable for piercing body tissue. The tip 11 has four facets 17 extending from the front end 18 which, in a known manner, form cutting edges at their meeting points. The portion 20 of the tip 11 accepts the threaded bore 15 and forms a transition from the facets 17 to the shank 10 when mounted _k the tip 11 on the shaft. In this embodiment the tip has a large cross-section compared to the shaft, so that during the penetration of the tissue the shaft can pass through the tunnel formed by the tip without interfering with the side walls of the tunnel. The tip is also wider (FIG. 4) than high (FIG. 3) in order to form a tunnel which has a shape suitable for receiving the tool 12.

The tool 12 is shown in side view in Fig. 3 and in cross section shown in FIG. After a tunnel is formed by means of the tip 11 and the shaft 10, the tip 11 removed from the shaft 10; the tool 12 is on the

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Shank 10 is assembled by engaging threaded end 14 with threaded bore 16. The tool 12 is adapted to engage a portion of the conduit to drive the conduit into the tunnel when the shaft 10 and tool 12 are withdrawn from the tunnel. That is, as the shaft is withdrawn, the tool 12 traverses the tunnel, thereby pulling the conduit into the tunnel. Preferably, the tool 12 engages the conduit at or adjacent one end of the conduit. According to a preferred embodiment, the tool 12 forms a connection housing which receives a line connection unit and pulls it together with the line through the tunnel when the shaft is pulled out. In the illustrated embodiment, the tool 12 is provided with a body 21 which has a central opening 22 for receiving a line component and a recess 23 for receiving a line emanating from the component.

Fig. 5 shows a connection unit 24 and part of the associated Line 25 together with a cross section of the tool 12. The opening 22 has such a shape that the body of the Connection unit 24 is received while the line 25 protrudes through the recess 23. The front wall 26 of the Opening 22 forms a bearing surface which engages a portion of the connector assembly 24 to accommodate the connector assembly pulling the tool 12 through the tunnel. The opening

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22 can assume different shapes and designs, depending on the design of the connection unit 24 or depends on another component with which the aperture is to be engaged.

The FIGS. 6 to 8 show the application of the embodiment according to FIGS. 3 to 5. The points between which the line should run are determined first; incisions 28 and 29 are made at these points. The tip 11 is mounted on the shaft 10 and inserted into the incision 28 (Fig. <5). The shaft 10 is handled by means of the handle 13 and guided in the direction of the incision 29 in order to exit there. After the shaft 10 has been arranged subcutaneously in this way, the tool II is removed; the tool 12 is mounted on the shaft 10; a line component (in the illustrated embodiment a connection unit) is inserted into the tool 12 (FIG. 7). The shaft 10 is then pulled out of the body tissue through the incision 28, whereby the line 25 is pulled through the tunnel formed by means of the tool 11. The tool 12 is disengaged from the connection unit 24; the line 25 remains between the incisions 28 and 2? arranged subcutaneously (Fig. 8).

In order to facilitate the movement of the assembly through the body tissue, the cross section of the shaft 10 is small

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Compared to the largest cross section of the tip 11.

FIG. 9 shows a further embodiment in which an elongated shaft 10 ', which corresponds to the shaft 10 of FIGS. 3, 6 and 7, is provided at one end with a handle 13 and at the other end 14 with a thread as in the case of FIG. A stop 30 is connected to the shaft 10 ′ by crimping or in some other way. The stop 30 can consist of the same material as the shaft 10 'or of another suitable material. A tube 31 made of a low friction material surrounds the greater part of the longitudinal dimension of the shaft 10 'between the stop 30 and the tool 12'. The stop 30 holds the tube 31 in place on the shaft 10 '. The tube 31 facilitates the movement of the arrangement through body tissue, because the low-friction material of the tube 31 can be passed through body tissue more easily than a shaft made of the preferably suitable materials. If the shaft 10 or 10 'has to be adapted to a body contour in order to limit the depth of penetration, the tube 31 must be adaptable together with the shaft 10'. A preferred material for the tube 31 is Teflon.

The tool 12 'represents a modified version of the tool 12; it agrees with this with the exception that at facets 32 are additionally present at the end adjacent to the shaft 10 ′. The meeting points of the facets 32 form intersections

909885/08 7 * 6

Edges or the fabric will split apart ·? Kor: r tr .., as "applies similarly to the facets 17 of the tool Π. J ^ ^ ccl ·" the size of the line component η e η te, m i tder ei i. E W 3; * '<z -. \ ::: -. ) 2 and 12 'are brought into engagement ä · ί s ο 1.1 e η, k ο ι; η dsr 7 ;: η η s 1 g α η ζ by the company υ g I 1 ge bi 1 ei er we rcl? π, Dei 5 h e i ^ i,.: ■ * · 5 .--?: ■ k

stuff! 1 can be big enough according to tv / s cd eη_, υm ρ ι.η ■; - - ■; T :, · τ \ r%; ι .; ϊ -

Reaching r size rather ζ υ ste 11 e η ,. de r egg; ι ε k 1 ^ l η era · .-. i!: "; η c 5 ■ <· :, ^r ., - ρ on en te , the larger: i ^: c ■ ' c h represents,' ■ · ■■ ''". r>"..?^';;:;.? ~ VI λ:, the SCH w h e r strength r is dυ r c h Kο r' ■ ■ ■ rc; β 'n ebe hi /";:, .r; 1 "■; ■ ^{..::: ':':} h = 1: ^γ.

In the case of a larger Leiti ingskoNiporisnie iiC3r.r · /.-S "■: ■■ · ■ -; y; -x: ji _ ■

be, a first tunnel with a point 11 c; jii; y!. 'i 1;>£; -:., ei v ,; smaller than the L ext υ η gsk ο m ρ ο η e η te I s i. υ η dc ;;; \ ·. T "■ r ■ r · -. ■ ι ζ ι <ν -s. r ■

bigger, if the ei tungkornporseri te i'iyrch >. ! as K ü.: ':;or;""-.' si · ξ

is pulled through. The tool 12 'of FIG. 7 client cisso; " Purpose, It engages, cuts, or divides the tissue with the conduit component just as the tool 12 does but additionally with the help of the edges formed by the meeting points of the facets 32 when the tool 12 'through the tunnel is pulled through.

The tools 11, 12 and 12 'can be at the same end of one Shank 10 or 10 "can be attached. It will be understood that Instead of a connection via thread, other means can also be provided to selectively attach the tools to the To attach the shaft. The tools 11 and 12 or 12 'can also in any appropriate manner to opposite

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lowing ends of a common shaft be mounted. This is illustrated in Fig. 10, where a common shaft 10 "on one end with a tool 11 in the form of a tip and on the other end is equipped with a tool 12 or 12 '. The principle of the arrangement of Fig. 10 is the same as that the embodiment of FIG. 3 with the exception that the tool 11 does not need to be removed in order to achieve the Tool 12 or 12 'and that the shaft 10 "in is pulled out in the same direction in which it was inserted, while the shaft 10 in the opposite direction of insertion Direction is pulled out. The shaft 10 ″ can be equipped with a handle in any suitable manner e.g. a handle which can be brought into engagement with one or both ends of the shaft 10 ', after the tool attached there has been removed.

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Claims (17)

PATENT ADVERTISER DlPL-LNG. GERHARD SCHWAN ELFENSTRASSE 32 · D-3000 MÜNCHEN 83 ^ _ "n <& y c, y 4 3 w P - 300 claims 1. 'Device for forming a tunnel in body tissue, characterized by an elongated shaft (1, 10, 10 ', 10' '), which can be adapted to a body contour by hand and is provided at one end with a body tissue penetrating tip (2, 11), a handle (3, 13) for manipulation of the shaft and a seat on the shaft that facilitates the movement of the device through body tissue, the Shape of the shaft adjustable tube (4, 31) made of a material of low friction. 2. Apparatus according to claim 1, characterized in that the handle (3, 13) relative to the shaft (1, 10, 10 ¹ , 10 ") is arranged offset in a single direction. 3. Device for forming a tunnel in body tissue, characterized by an elongated shaft (1, 10, 10 ', 10 "), which can be adjusted by hand to a body contour and is provided at one end with a body tissue penetrating tip (2, 11), a handle (3, 13) for maneuvering 909885/0878 TELEPHONE: 089/6012039 CABLE: ELECTRICPATENT MUNICH L - pulping of the shaft and a device facilitating the passage of the device through body tissue [A ₁ 31). 4. Device for passing through a body stimulator lead subcutaneously between body parts lying at a distance from one another, characterized by an elongated one Shaft (10, 10 ', 10 ") and engaged with the shaft tools (11, 12, 12 ') that can be brought in, one for piercing of tissue suitable tip (11) and one with the Line (25) engageable driver (12, 12 ') exhibit. 5. Apparatus according to claim 4, characterized in that the shaft (10, 10 ', 10 ") can be adapted to a body contour by hand is. 6. Apparatus according to claim 4 or 5, characterized in that the tools (11, 12, 12 ') can optionally be brought into engagement with the same end (14) of the shaft (10, 10', 10 "). 7. Apparatus according to claim 6, characterized in that the shaft end (14) has a thread and the tools (11, 12, 12 ') are provided with threaded bores (15, 14). ..IN THE 909885/0876 8. Device according to one of claims 4 to 7, characterized in that that the line (25) has a component (24) which can be brought into engagement with the driver (12, 12 '). 9. Apparatus according to claim 8, characterized in that the driver (12, 12 ') with a housing-like body (21) provided for receiving the line component (24) is. 10. Apparatus according to claim 8 or 9, characterized in that that a line connection unit (24) is provided as a line component. 11. Device according to one of claims 4 to 10, characterized by a handle (13) for handling the shaft (10, 10 ', 10 "). 12. Device according to one of claims 4 to 11, characterized by a device (31) which facilitates ^{the movement of the shaft (10!) In the body tissue.} 13. Apparatus according to claim 3 or 12, characterized in that that the movement of the shaft (1, 10 ') in the body tissue Facilitating device a tube (4, 31) made of a material and surrounding at least a large part of the shaft has low friction. 909885/0876 14. The device according to claim 1, 2 or 13, characterized by a stop (5, 30) for limiting the movement of the tube (4, 31). 15. Device according to one of claims 4 to 14, characterized characterized in that the tools (11, 12, 12 ') on opposite Ends of the shaft (10, 10 ', 10 ") are attached. 16. Device according to one of claims 4 to 15, characterized characterized in that the driver (12 ') is pierced of tissue suitable means (32). 17. Device for subcutaneous positioning of the lead of a body stimulator, characterized by a elongated shaft (10, 10 ', 10 "), a device (13) for manipulating the shaft, one with the one First tool (11) which can be brought into engagement at the end of the shaft for separating body tissue when the Shaft in body tissue and a second tool (12, 12 ') for subcutaneous positioning of the lead when pulling the shaft out of the body tissue. 909885/0876