This application is a United States National Phase application of International Application PCT/EP2010/003166 and claims the benefit of priority under 35 U.S.C. §119 of German Patent Application DE 10 2009 022 692.3 filed May 26, 2009, the entire contents of which are incorporated herein by reference.
The present invention pertains to a device and a method for applying a medical lockable clip in a tissue area.
Such a device is known from EP 1 199 990 B1. The drawback of the prior-art device is that the force for shooting in and closing the clip must be applied manually and the operation does not therefore lead to reliably reproducible, identical results; poor placement of the clip may at times occur as well.
A basic object of the present invention is therefore to provide a device and a method of the type mentioned in the introduction, which device and method make possible the reliable and reproducible placement of such clips in body tissues.
Said object is accomplished according to the present invention with a device for applying a medical lockable clip in a tissue area, which has the following features:
a) an automatic feed mechanism, which can be moved from a starting position in the direction of the tissue area, with a guide in the feed direction for the clip, wherein the clip has two gripping teeth directed in the direction of feed,
b) a stop for the feed mechanism as well as
c) a locking element movable with the feed mechanism with a clip-side locking mechanism for locking the clip, wherein
d) the locking element can be set into motion together with and in parallel to the feed mechanism, and
e) the stop does not limit the motion of the locking element.
To accomplish said object, the present invention also provides for a method for applying a medical lockable clip in a tissue area with the following steps:
a) Insertion of the clip into the guide of an automatic feed mechanism with the device, wherein the clip has two gripping teeth directed in the direction f feed,
b) automatic joint initiation of the feeding of the feed mechanism, of the locking element and of the clip in the direction of the tissue area up to a stop, which hinders a further feeding of the feed mechanism,
c) further selective automatic feeding of the locking element up to the clip, wherein this locking element triggers a clip-side locking mechanism for locking the clip.
An automatic device is a device that allows certain actions to take place independently and in a constrained manner after a triggering pulse. Accordingly, an automatic method is a method in which predetermined actions take place after a triggering pulse independently and in a constrained manner. This may happen especially by means of a motor, wherein various types of motor drives, such as pneumatic, hydraulic, electric or even electromagnetic types, may be used.
It is achieved by the present invention that the clip can be shot into and closed in a certain tissue with equal force, so that equal, reproducible results can also be obtained. In addition, it becomes possible to use different shoot-in forces in tissues having different firmness or hardnesses in order to achieve reliable fixation of the clip even independently from the consistency of the tissue. In addition, both a higher shoot-in velocity and a stronger closing force can be applied through the present invention than it would be possible manually, as a result of which the fixation of the clip is likewise improved. The device may have a positive-locking or frictionally engaged mount for the clip, the locking element having a toggle lever element, which presses the gripping teeth of the clip against each other and releases the positive-locking and/or frictionally engaged mount of the clip. Provisions are made in a preferred embodiment for the mount to hold the clip preferably in a positive-locking manner by nubs, which mesh for locking the clip with corresponding nubs or depressions, which are formed in the clip mount, being provided laterally at the clip or the tooth flanks thereof. The positive-locking connection can be abolished by the change in the shape of the clip during the actuation of the toggle lever mechanism.
As an alternative, provisions are preferably made for the clip mount to hold the clip in a frictionally engaged manner in the clip mount itself or by a sliding press fit between a possible upper guide and a lower guide in the clip mount.
Provisions are made in preferred embodiments of the present invention for the feed mechanism to be formed by a shoot-in cylinder and for the locking element to be formed by a closing piston and/or to run in a cylinder liner of the shoot-in cylinder, in which the closing piston is sealingly guided.
In addition, provisions may be made in an alternative embodiment for the shoot-in cylinder and the closing cylinder to be connected via a T-shaped distributor and a pressure line, wherein a reducer is arranged in the pressure line leading to the closing cylinder, or they are connected by a spring, which is arranged between the feed mechanism and the locking element and which applies pressure on the latter components.
As a result, pressure is applied simultaneously and at equal value to both the shoot-in cylinder and the closing cylinder. The shoot-in cylinder is fed first up to the above-mentioned stop during the motion of the feed mechanism and it thus pushes the closing cylinder forward. The pressure admitted is admitted to the closing piston in a slowly increasing manner due to the reduced line cross-section of the reducer and to the length of the closing cylinder, which length is determined by the pressure line, and the locking element thus continues to be moved with a time offset, as a result of which the locking element acts on the toggle lever with a time difference from the feed mechanism.
It is reliably achieved as a result that the clip is first shot into the body tissue and it is then closed by the motion of the teeth towards one another.
Provisions are made in further preferred embodiments of the present invention for the locking element to have a guide for the clip as well as a restoring means for the pneumatic feed mechanism and the locking element for returning into the starting position, wherein the restoring means comprise especially pneumatic restoring pistons.
A manual valve actuation is followed according to the present invention by a pneumatically controlled triggering of the method according to the present invention. By contrast, the triggering mechanism is designed in a preferred embodiment as a device comprising an actuating valve, an auxiliary cylinder and an opening valve, wherein the compressed air feed is opened only after a predetermined opening pressure is reached. This guarantees that the method according to the present invention is always carried out with the same pressure and the same feed motion of the clip.
Provisions may preferably be made in an alternative embodiment of the pneumatic feed mechanism for the shoot-in piston within the shoot-in cylinder releasing a pressure connection from the wall of the shoot-in cylinder to the closing cylinder during the triggering after a certain feed path. Pressure is thus admitted to the closing piston and to the shoot-in piston with a time offset without a separate compressed air line and/or a T-distributor.
In addition, a clip magazine with a serial clip feed may be provided in the starting position. Provisions are preferably made by the present invention in this connection for a plurality of clips directed in the distal direction to be able to be inserted laterally from the closing piston, wherein said clips are arranged one after another. The clips can be preferably fed from the proximal end of a possible magazine by feed means, e.g., a spring, in the distal direction against a distal stop at the clip mount. After a clip has been applied, the closing piston is pulled back and the so is preferably the clip mount, and the clip in the magazine, which is closest to the distal stop at the clip mount, is pushed into the clip mount, e.g., by a leaf spring, and the next clip in the magazine is pushed against the distal stop.
Furthermore, the present invention provides for securing against unintended triggering of the automatic method.
Further advantages and features of the present invention appear from the claims and the following description, in which an exemplary embodiment of the present invention is explained in detail with reference to the drawings. The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and specific objects attained by its uses, reference is made to the accompanying drawings and descriptive matter in which preferred embodiments of the invention are illustrated.
In the drawings:
Referring to the drawings in particular, the resorbable clip used according to the present invention has centrally a deformable shoulder 1.1, on one side of which clip a tooth 1.2 each with a sharp tip 1.3 is formed at the end areas on one side of the clip.
On the side of the shoulder 1.1 located opposite the teeth 1.2, a toggle lever 1.4 is likewise formed in one piece, which is connected to the shoulder 1.1 via film hinges 1.5 and the two parts of which are likewise connected centrally to one another via a film hinge 1.6.
Under the toggle lever 1.4, the shoulder has a recess 1.7, into which the toggle lever 1.4 can be used in the overstretched position. The deformable shoulder 1.1, the toggle lever 1.4, the film hinges 1.5 and 1.6 and the recess 1.7 provide a clip-side locking mechanism.
The device according to the present invention carries out the following steps one after another:
The device 2 according to the present invention has, at first, an essentially parallelepipedic housing 2.1 (shown only partially for clarity's sake), which has, on the one hand, a shooting unit 2.2, comprising a shoot-in cylinder 3 and a closing cylinder 4 with integrated safety means to prevent accidental triggering, and, on the other hand, a cylinder liner 2.3, with which the closing cylinder 4 is guided.
A shoot-in piston 3.1, which is screwed into the connection piece 2.2a of the shooting unit 2.2 by means of a thread, is arranged within the shoot-in cylinder 3. Furthermore, a closing cylinder 4, which is mounted in the cylinder liner 2.3 and is linearly movable together with the connection piece 2.2a, is connected to the connection piece 2.2a. Closing cylinder 4 is guided by means of a dog 4.1 in a groove 4.2 in housing 2.1. The feed motion of the shooting unit 2.2 is limited here by a stop 4.3 formed in the housing 2.1 for the dog 4.1.
At its front end, closing cylinder 4 has a clip mount 4.4, in which the clip 1 is held, especially in a positive-locking and angularly aligned as well as positioned manner. As is shown in
The clip is preferably also held laterally, as is also shown in the further embodiment in
A closing piston 4.5, which has a piston rod 4.6, which can act through the closing cylinder 4 onto the middle area of the toggle lever 1.4 of the clip 1 and can thus apply the closing force mentioned with reference to
A coil spring 6, which holds with a certain force the closing piston 4.1 in its position shown in
Furthermore, housing 2.1 has a restoring means for the shooting unit 2.2. A restoring valve 7 (shown in
Compressed air is correspondingly available permanently from the compressed air supply D1 at the triggering valve 2.2 (via D2), at the opening valve 2.6 (via D3) and at the restoring valve 7.
The compressed air supply D1 leads via an inlet and two Y-shaped distributors 2.4a, 2.4b arranged downstream one after another as well as via a pressure line D2 to a triggering valve 2.5. Triggering valve 2.5 has a manually actuatable rotary knob (not shown) and is connected via another pressure line to an auxiliary cylinder (both likewise not shown in
If the triggering valve 2.5 is opened, the compressed air is sent to the above-mentioned auxiliary cylinder, not shown (cf. auxiliary cylinder 8 in
Simultaneously with the application of pressure of the shoot-in cylinder 3, the compressed air is sent through a pressure reducer 5 arranged on a side of the distributor 2.7 opposite the shoot-in cylinder 3 through this reducer 5 and a pressure line D5 connected to same through the transition piece 2.2a of the shooting unit 2.2 into the closing cylinder 4 behind the piston head 4.7 of the closing piston 4.5. The closing piston 4.5 is thus fed through the closing cylinder 4 in a time-delayed manner by a time difference t and shoots with considerable force against the center of the toggle lever 1.4, as a result of which the closing force described with reference especially to
Restoration of the closing piston 4.5 and of the piston head 4.7 is guaranteed by a coil spring 5, whose prestress pushes back the closing piston 4.5 with a certain weak force into the starting position thereof, which is shown in
The sequence of the pneumatic circuit diagram is as follows:
The direction of the compressed air is described in the pneumatic circuit diagram by a triangle 9 directed in the direction of the compressed air flow, and thus it shows that the compressed air flow is sent, starting from the compressed air supply D1, from the triggering valve 2.5 to the auxiliary cylinder 8. The first circuit symbol in the pneumatic method in
Valve 2.5 is followed by the auxiliary cylinder 8, which is a single-acting cylinder with a piston-side, adjustable restoring spring 8a and with a cylinder piston 8b, wherein an arrow through the valve designates the adjustability of restoring spring 8a. The compressed air line D8 sends compressed air from valve 2.5 into the front, spring-loaded area of the auxiliary cylinder 8. Spring 8a is compressed by means of the compressed air against its action by the cylinder piston 8b. When a predefined opening pressure, which is preset by setting the spring rate of spring 8a, is exceeded, spring 8a triggers the auxiliary cylinder 8 and brings the cylinder piston 8b back into the starting position thereof. Cylinder piston 8b is connected to a valve plunger 2.6a of the opening valve 2.6 and thus actuates the opening valve 2.6 when returning into its starting position. This is another 3/2-way valve with a restoring spring 2.6b and a vent hole 2.6c, which valve is triggered by the auxiliary cylinder 8 via the manually actuatable valve plunger 2.5a.
Auxiliary cylinder 8 and opening valve 2.6 act as a closing accelerator. It shall be guaranteed that the same pressure can flow through the lines with each use of the method according to the present invention, the shoot-in piston 3.1 is always fed with the same pneumatic force and thus it always presses the clip into the tissue with the same acceleration and force. The variable actuation by the user's muscle strength is thus compensated, because he does not trigger the valve with the same strength during each use of the device according to the present invention.
A T-shaped distributor 2.7 branches off a pressure line D4 coming from the opening valve 2.6. Compressed air is sent, on the one hand, to the shoot-in cylinder 3, which is a double-acting cylinder with damping adjustable on both sides. On the other hand, compressed air is sent through a reducer 5 by means of a pressure line D5 into the rear part of the closing cylinder 4. Shoot-in cylinder 3 is a cylinder with a damping adjustable on both sides, which cylinder can thus be moved in two directions.
An arrow through the circuit symbol of the shoot-in cylinder 3 indicates the adjustability of the cylinder, because the cylinder can be operated with different pressures. Compressed air enters the rear part of the shoot-in cylinder from the distributor 2.7 and brings about the feed thereof (cf.
The pneumatic restoring means of the shoot-in cylinder 3 is designated by the restoring valve 7, a 3/2-way valve with restoring spring 7a and with a vent hole 7b, which valve is actuated by muscle strength by means of valve plunger 7c. The compressed air is sent through the valve 7 via the compressed air line D7 into the front part of the shoot-in cylinder 3 and it thus pushes the shoot-in piston 3.1 back again into its starting position (cf. description for
It appears from the above that as soon as an operator—a physician—moves the triggering valve 2.5 into an open position, the further method takes place automatically under the action of the compressed air released, namely in three steps, by the clip 1 being first moved by the shoot-in cylinder 3 out of the housing 2.1 of the device 2 and being shot into the tissue. After blocking of the shoot-in cylinder 3, the clip 1 is closed in a second step by the stop 2.9 under the action of the inner closing piston 4 on the toggle levers 1.4 and is thus fixed to the tissue. As a last step, the shoot-in piston is moved again into the starting position by actuating the restoring valve 6 and limiting the rearward motion by the rear wall of the shoot-in cylinder 3.
Instead of an automatic pneumatic action method, as it was brought about on the basis of the triggering pulse brought about by the actuation of the compressed air valve, an automatic hydraulic or electrically or even electromagnetically controlled method may take place as well, for example, by means of an electric motor drive or even a sealed action on electromagnets, which move first the shoot-in cylinder 3 and then the closing piston 4.5 of the housing 2.1 of device 2 in the forward direction (left in the drawings).
Number | Date | Country | Kind |
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10 2009 022 692 | May 2009 | DE | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/EP2010/003166 | 5/25/2010 | WO | 00 | 11/28/2011 |
Publishing Document | Publishing Date | Country | Kind |
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WO2010/136170 | 12/2/2010 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
3616497 | Esposito | Nov 1971 | A |
4317451 | Cerwin et al. | Mar 1982 | A |
4325376 | Klieman et al. | Apr 1982 | A |
4349028 | Green | Sep 1982 | A |
4388747 | Plummer | Jun 1983 | A |
4424929 | Weis | Jan 1984 | A |
4485952 | Weis | Dec 1984 | A |
4514885 | Delahousse et al. | May 1985 | A |
4569469 | Mongeon et al. | Feb 1986 | A |
4763390 | Rooz | Aug 1988 | A |
4839947 | Cohen et al. | Jun 1989 | A |
4887601 | Richards | Dec 1989 | A |
4943294 | Knapp | Jul 1990 | A |
4983176 | Cushman et al. | Jan 1991 | A |
5047047 | Yoon | Sep 1991 | A |
5236440 | Hlavacek | Aug 1993 | A |
5258007 | Spetzler et al. | Nov 1993 | A |
5425489 | Shichman et al. | Jun 1995 | A |
5437681 | Meade et al. | Aug 1995 | A |
5464413 | Siska et al. | Nov 1995 | A |
5490651 | Kump | Feb 1996 | A |
5862972 | Green et al. | Jan 1999 | A |
5876410 | Petillo | Mar 1999 | A |
6010513 | Tormala et al. | Jan 2000 | A |
D426767 | Meyers | Jun 2000 | S |
6210419 | Mayenberger et al. | Apr 2001 | B1 |
6261303 | Mayenberger et al. | Jul 2001 | B1 |
6301756 | Howard | Oct 2001 | B1 |
6387113 | Hawkins et al. | May 2002 | B1 |
6461364 | Ginn et al. | Oct 2002 | B1 |
6793663 | Kneifel et al. | Sep 2004 | B2 |
7056330 | Gayton | Jun 2006 | B2 |
7264625 | Buncke | Sep 2007 | B1 |
7559125 | Cofer | Jul 2009 | B2 |
7740159 | Shelton et al. | Jun 2010 | B2 |
7875029 | Hausen | Jan 2011 | B1 |
7950559 | Peterson et al. | May 2011 | B2 |
8157145 | Shelton et al. | Apr 2012 | B2 |
8336752 | Viola | Dec 2012 | B2 |
8393517 | Milo | Mar 2013 | B2 |
20020062130 | Jugenheimer et al. | May 2002 | A1 |
20020065535 | Kneifel et al. | May 2002 | A1 |
20040087987 | Rosenberg et al. | May 2004 | A1 |
20060079115 | Aranyi et al. | Apr 2006 | A1 |
20060151567 | Roy | Jul 2006 | A1 |
20060247643 | Bhatnagar et al. | Nov 2006 | A1 |
20070233187 | Lobello | Oct 2007 | A1 |
20080140089 | Kogiso et al. | Jun 2008 | A1 |
20080177300 | Mas et al. | Jul 2008 | A1 |
20090149870 | Jugenheimer et al. | Jun 2009 | A1 |
20110106148 | Ginn et al. | May 2011 | A1 |
Number | Date | Country |
---|---|---|
19935904 | Jul 2001 | DE |
1 199 990 | May 2002 | EP |
1 199 990 | Sep 2004 | EP |
Number | Date | Country | |
---|---|---|---|
20120071899 A1 | Mar 2012 | US |