|Número de publicación||US20080004606 A1|
|Tipo de publicación||Solicitud|
|Número de solicitud||US 11/855,534|
|Fecha de publicación||3 Ene 2008|
|Fecha de presentación||14 Sep 2007|
|Fecha de prioridad||3 Abr 2003|
|También publicado como||CN1767869A, CN100464798C, US7288074, US20040199087, US20040199088|
|Número de publicación||11855534, 855534, US 2008/0004606 A1, US 2008/004606 A1, US 20080004606 A1, US 20080004606A1, US 2008004606 A1, US 2008004606A1, US-A1-20080004606, US-A1-2008004606, US2008/0004606A1, US2008/004606A1, US20080004606 A1, US20080004606A1, US2008004606 A1, US2008004606A1|
|Inventores||Paul Swain, Gary Long|
|Cesionario original||Swain Paul C, Long Gary L|
|Exportar cita||BiBTeX, EndNote, RefMan|
|Citada por (21), Clasificaciones (11)|
|Enlaces externos: USPTO, Cesión de USPTO, Espacenet|
This application claims priority to and incorporates by reference Great Britain Patent Application Serial No. 0307715.3 filed Apr. 3, 2003 and having the same title.
This invention relates to a guide wire structure for insertion into an internal space defined by a wall. The invention is particularly concerned with a guide wire structure which can be inserted into an interior space within a human or animal body. More particularly, it concerns a guide wire device which can be inserted into, and moved along, a lumen within the body of a human patient, for example within the gastrointestinal (GI) tract of a human patient.
A physician typically accesses and visualizes tissue within a patient's gastrointestinal (GI) tract with a long, flexible endoscope. For the upper GI, a physician may insert a gastroscope into the sedated patient's mouth to examine and treat tissue in the esophagus, stomach, and proximal duodenum. For the lower GI, a physician may insert a colonoscope through the sedated patient's anus to examine the rectum and colon. Some endoscopes have a working channel, typically about 2.5-3.5 mm in diameter, extending from a port in the handpiece to the distal top of the flexible shaft. A physician may insert medical instruments into the working channel to help diagnose or treat tissues within the patient. Physicians commonly take tissue biopsies from the mucosal lining of the GI tract using a flexible, biopsy forceps through the working channel of the endoscope.
Insertion of a flexible endoscope, especially into the colon, is usually a very time-consuming and uncomfortable procedure for the patient, even when sedated with drugs. A physician often needs several minutes to push a flexible endoscope through the convoluted sigmoid, descending, transverse, and ascending portions of the colon. The physician may diagnose and/or treat tissues within the colon either during insertion or removal of the endoscope. Often the flexible endoscope “loops” within the colon, such as at the sigmoid colon or at the splenic flexure of the colon, so that it becomes difficult to further advance the endoscope along the colon. When a loop is formed, the force exerted to push the scope stretches the mesentery and causes pain for the patient. Depending on the anatomy of the patient and the skill of the physician in manipulating the flexible endoscope, some portions of the colon may be unexamined, thus increasing the risk of undiagnosed disease.
Given® Engineering LTD, Yogneam, Israel, sells a device in the U.S. called the M2A™ Swallowable Imaging Capsule. The device contains a tiny video camera, battery, and transmitter. It is propelled through the gastrointestinal tract by natural peristalsis. The device is currently used for diagnostic purposes and passes through the intestinal tract with a velocity determined by the natural, peristaltic action of the patient's body. PCT publication No. WO 01/08548 describes a self-propelling device adapted to travel through a passage having walls containing contractile tissue. The applicants disclose that the device is particularly useful as an enteroscope and may also carry objects such as feeding tubes, guide wires, physiological sensors or conventional endoscopes within the gut. A summary of other alternative to push endoscopy can be found in “Technical Advances and Experimental Devices for Enteroscopy” by C. Mosse, et al, published in Gastrointestinal Endoscopy Clinics of North America, Volume 9, Number 1, January 1999: pp. 145-161.
Guide wires have been used to aid the introduction of catheters and other instruments into many sites in the human body. Many medical applications and specific designs of guide wires have been for cardiovascular use. There are, however, specific challenges relates to the use of guide wires in the GI tract, as opposed to the vascular system. Thus, the bowel is more tortuous, softer and generally of larger diameter. Furthermore, in the case of the small intestine and the colon, these are longer than most arteries or veins. It is an object of an aspect of the invention to provide a guide wire structure which is capable of being advanced along the GI tract, and which, under appropriate conditions and with sufficient medical skill, can be used safely even when passing through complex looped formations of small intestine.
According to the present invention, there is provided a guide wire structure for insertion into an interior space defined by a wall, the guide wire structure comprising at least two guide wires each having a leading end portion which terminates in a leading end, the guide wires being connected to one another at or adjacent their leading ends, the guide wires have a first position in which the leading end portions are substantially parallel to one another, a second position in which the leading end portions are curved, and a third position in which at least one of the leading end portions forms a loop. It is to be understood that, as used herein, the term “loop” does not necessarily denote a complete loop, but also includes a partial loop. It is also to be understood that the two guide wires (or, where there are more than two guide wires, any two of the guide wires) may be in the form of a continuous piece of guide wire material whose two ends are brought together where the connection is formed.
A primary purpose of the above structure is for insertion into an interior space within a human or animal body, for example into the GI tract of a human patient. It is believed that the guide wire structure of the present invention should be capable of being negotiated through the small intestine or colon, and may allow the delivery of endoscopic devices even to relatively inaccessible parts of the gut such as the cecum (accessed via the anus) and the distal jejunum and ileum (accessed via the mouth).
In one embodiment of the invention there are precisely two guide wires connected to one another at their leading ends. For many purposes, two wires are believed to be sufficient. However, in some circumstances more than two wires may be appropriate, and the present invention envisages that the guide wire structure may have three wires, four wires, or even more than four wires.
The invention is described further below with reference to the accompanying drawings, in which:
The structure of
The guide wires 2 and 3 can be made of the materials conventionally used for guide wires, for example straight stainless steel wire, coiled stainless steel wire, glass fiber, a plastics material, or nitinol. Conveniently, a guide wire has a floppy tip, i.e. a leading end portion, typically 4-5 cm in length, of greater flexibility than the remainder of the guide wire, in order to reduce the risk of the leading end of the guide wire causing damage to the wall of the lumen through which it is passing. Where two such conventional guide wires are joined together to produce the guide wire structure of the present invention, it will of course be these floppy tips, or parts thereof, which are joined together. Preferably, the length of the junction is less than the length of the floppy tips, so that some length of floppy material remains which is unaffected by the junction.
The whole or part of each of the guide wires may be coated to reduce its coefficient of friction, as is done with conventional guide wires. For example, guide wires can be coated with a low friction material such as silicone, or with a hydrophilic material which becomes slippery in use in a patient, or with both a low friction material such as silicone and hydrophilic material applied over the low friction material.
The junction 3 can be formed in any desired manner, provided the resulting leading end of the guide wire structure is not such as to damage the wall of the GI tract or other body lumen, nor cause undue pain when in contact therewith. For example, the junction can be made by gluing or welding the leading end portions together and, preferably, then covering those portions with heat shrink tubing. Alternatively, the end portions could be held together by having a metal band crimped on to them, optionally enclosed by a cover made of a softer material.
It is not essential for all the guide wires, or both the guide wires, as the case may be, to be of material which would normally be regarded as guide wire material. For example, in the case of a guide wire structure consisting of just two guide wires, one of the guide wires may be made of a thread, which is joined to the other guide wire by being tied to it.
Yet another possibility would be to start with a single guide wire of twice the required length and fold it sharply back on itself, for example by crimping the folded wire adjacent the fold, so that it became, in effect, a pair of guide wires joined at the fold. A guide wire structure having an even number n of guide wires greater than two could be formed by folding half that number of guide wires.
The principle of operation of the guide wire structure can be seen by comparing
To enable the physician to easily advance one of the guide wires while keeping the other still, the guide wires are preferably received, at their ends remote from the junction 3, in a handle which can be moved up and down the guide wires as they are advanced and retracted. The handle should allow precise regulation of the relative lengths of the two guide wires. It should also allow the introduction of the various catheters, imagers and other accessories, discussed in more detail below, giving accurate information on their relationship to the junction 3. The handle may be provided with a reversible motor drive which enables both guide wires to be driven. The motor drive itself may provide data to enable the user to monitor the lengths of the guide wires which have been fed forward.
An example of a handle is illustrated in
The combined effect of the forms of behaviour illustrated in
Furthermore, the presence of a loop at the leading end of the structure rather than the tip of a single wire, makes the structure more likely to follow the main course of the lumen, and less likely to inadvertently enter branches off it. Thus, in the case of the gut, there will be a much reduced tendency to enter, for example, diverticulae or the orifice of the appendix. However, the fact that the loop is not permanently present, and can be eliminated by putting the structure into the configuration shown in
It is desirable in endoscopic procedures to avoid, or at least reduce, the use of X-ray imaging to monitor what is taking place. With this in mind, the guide wires are preferably each provided with a pattern of markings, distributed along their length, to indicate how far each individual guide wire has been inserted. One such pattern in shown in
Additionally, or instead, the guide wire structure can be provided with other forms of position indication. It is known to provide a conventional guide wire with a series of miniature electrically conductive coils which surrounded the guide wire and are spaced along its length, the coils being connected to a source of electrical current, whereby each coil becomes a miniature electromagnet. Such coils can be provided on the guide wires used to form the guide wire structure of the present invention. A sensing device outside the patient is used to detect the position of the coils within the patient, and thereby determine the location of the guide wires.
The path of the guide wire structure can be influenced by the use of a catheter, which can be passed over one or both of the two guide wires, when there are precisely two, or over one, some, or all of the guide wires, when there are more than two. In one particularly advantageous embodiment the catheter has a curved tip, which allows the application of torque to bias the forward motion of the guide wire (or wires) over which it passes in any given direction. The use of a catheter in this way is illustrated in
The purpose of the guide wire is, as its name indicates, to act as a guide for some other element. Accordingly, when the guide wire structure of the present invention is in place some other element is then passed over it.
As in the case of a catheter used to influence the path of a guide wire structure during passage of the guide wire structure along a lumen, a catheter introduced subsequently can pass over one or both of the guide wires, when there are precisely two, or over one, some, or all of the guide wires, when there are more than two. When the catheter is passed over both, or all, the guide wires, as the case may be, the leading end of the catheter will be free to pass beyond the leading end of the guide wire structure once it reaches that point. If the catheter is not passed over both, or all, the guide wires, for example if it is passed over only one of two interconnected guide wires, the leading end of the catheter will normally be unable to pass beyond the connection between the guide wires. That may be desirable, for the purpose of ensuring that the leading end of the catheter can be brought to a position previously defined by the leading end of the guide wire structure. It also has the result, however, that if the guide wire structure is withdrawn, the catheter must be withdrawn with it.
If it is desired to enable the leading end of the catheter to pass beyond the end of the guide wire over which it is travelling, or to enable the catheter to remain in position after the guide wire has been withdrawn, this can be achieved by providing the leading end of the catheter with a cutting device. The use of such a catheter is illustrated in
The cutting catheter comprises a cylindrical cutting member 66 with a circular cutting edge 67 (visible in
Once a sufficiently large guide wire loop has been formed in, say, the gut, it becomes possible to pull the gut backwards to some extent, using the friction between the loop and the wall of the gut. To do this, both guide wires are pulled backwards in synchronism. This provides a means for straightening the gut, and this in turn makes it easier to advance the guide wire structure further or, indeed, to advance other structures (e.g. endoscopes), and reduces the pain of the procedure, which is mainly caused by stretching nerve endings in the mesentery.
The above described concept of using a guide wire loop to straighten a passageway, e.g. the gut, can be further developed in an embodiment of the present invention which employs two guide wire structures operating in parallel. An example of such an embodiment is shown in
The embodiment shown in
The above cycle is then repeated until the desired degree of advancement has been achieved.
A similar cycle of steps can be achieved by a modified form of the embodiment of
Many different devices can be passed over the guide wire structure, and some examples will now be given.
Once the guide wire, and the imager referred to in (a) above, have reached the desired location, an overtube could be passed, for example to the cecum. The guide wire and the imager could then be withdrawn and a conventional endoscope could be passed through the overtube to deliver therapy, for example removing a polyp or cancer.
A conventional endoscope could be introduced into a body lumen by passing it over the guide wire structure of the present invention. However, a conventional endoscope would normally be too stiff for this to be possible, and the guide wire structure of the present invention offers the possibility of, in effect, constructing an endoscope within a patient. To achieve this, a number of catheters, each providing one or more of the utilities normally provided a conventional endoscope, are successively passed over one or more of the guide wires, so that result is an assemblage of these various elements within the patient. A particular advantage of proceeding in this way is that the force required to advance each of the individual catheters is substantially less than that required to advance a complete conventional endoscope (e.g. a colonoscope or an enteroscopc), since the latter is much stiffer and has much greater mass. It is therefore easier for the physician, and less uncomfortable for the patient, and is less likely to cause injury to the patient. Also, since the endoscope is then assembled element by element, the endoscope can have those facilities which are required for the particular patient, and, only those facilities, so that the endoscope is tailored to the requirements of the medical procedure being carried out. It will be understood that, for the purpose of allowing in situ assembly of a catheter, the guide wire structure should preferably comprise more than two guide wires, for example three or four guide wires.
Although a structure having more than two guide wires is particularly useful for the purpose discussed above of assembling an endoscope in situ, it may also have value in relation to the procedure for introducing the guide wire structure into a lumen. This is because the two-guide wire structure shown in
Attention is now directed to
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|Clasificación de EE.UU.||606/1|
|Clasificación internacional||A61B1/31, A61B17/00|
|Clasificación cooperativa||A61B2017/003, A61M2025/09175, A61M25/09025, A61M2025/09133, A61B1/31, A61M25/09|
|Clasificación europea||A61M25/09B1, A61M25/09|