KR101046874B1 - Probe for insertion into the anal canal - Google Patents

Abstract

The present invention relates to a probe (1) for insertion into the anal canal of a patient. The probe comprises a hollow (6) tubular member having a closed end (3) configured to enter the anal canal and an open end (2) opposed thereto and for receiving a surgical instrument, and a portion of the anal canal of the patient being directed into the groove. And at least one groove (4, 4a, 4b, 4c) extending longitudinally and provided in the side wall of the hollow member for entering, the groove being the open end of the hollow member for testing and treatment of the anal canal region. Access is possible through adjacent openings 5, 5a, 5b, 5c.

Insertion probe for anal canal, anal canal, faecal incontinence, fecal incontinence, drug injection

Description

A probe for insertion into the anal canal {A PROBE FOR INSERTION IN THE ANAL CANAL}

The present invention relates to probes inserted into the anal canal and rectum of the body for the purpose of examining and treating patients suffering from diseases in the anal canal and rectum. More specifically, the present invention relates to probes used for the treatment of patients suffering from anal incontinence in the anal canal by injecting bulking agents to ensure a limited fecal / fart pathway in the anal canal.

Fecal incontinence is a disease that is widespread in many people and several types of drug and surgical treatments have been developed and used to treat patients. For example, various methods of anal sphincter surgical correction are used to improve the function of the sphincter, where an artificial anal sphincter instrument is implanted in the patient to prevent fecal / fart leakage, or volume enlarged in the anal canal tissue to limit the stool pathway. I can be injected. The present invention is preferably used in connection with the latter method of volumetric agent injection.

The outer layer of the anal canal is mostly covered with mucosal tissue, making it difficult to sterilize it sufficiently in that area. Thus, the risk of infection increases when any substance is inserted through the anal mucosa. Therefore, it is now desirable for surgeons to infuse volumetric agents from the outside (via buttock muscle tissue) without going through the anal canal to minimize the risk of anal canal damage and infection. However, it is extremely difficult to determine the exact location to which a certain amount of volume expanding agent is administered even through the ultrasonic control using the prior art.

In addition, whether for inspection or surgical purposes, it is very easy for the surgeon to examine and interact with the patient's organs and cavities to perform the most successful and comfortable procedures for the patient. Important, but not the current way

It is an object of the present invention to provide a device for use in treating the anal canal via the anus.

It is a further object of the present invention to provide a device for use in the treatment of the anal canal through the anus which minimizes or completely eliminates the risk of damage to the anal canal and in particular the rectum during examination and treatment using an external device.

It is another object of the present invention to provide a device for use in the treatment of the anal canal via the anus which facilitates the way of reaching the exact location to be treated.

Another object of the present invention is to provide a method for examining and treating patients suffering from anal canal disorders, which alleviates pain more quickly.

The above object is achieved by the probe according to the first embodiment of the present invention, wherein the probe inserted into the anal canal and rectum of the patient has an open end disposed opposite the closed distal end configured to enter the anal canal and accommodating the surgical instrument. A hollow tubular member having a hollow tubular member, and at least one groove extending in a side wall of the hollow member to allow a portion of the anal canal of the patient to enter therein for examination and treatment; The groove is accessible through an opening adjacent the open end of the hollow member for examination and treatment of part of the anal canal.

The mucosal tissue of the anal canal will fall into the groove of the tube member. The anal canal tissue thus uses a hollowed cannula inserted into the tissue between the mucosal and muscular tissue surrounding the anal canal, for example into the tissue in the groove through the opening adjacent the open end of the hollow member. Thus, it is placed in a good position for injecting the bulking agent. This provides a significant advantage over the prior art in injecting the bulking agent in the correct position.

The probe preferably includes a head portion formed near or at the closed distal end and rotatable about an axis of rotation that is parallel to, but not coincident with, the longitudinal central axis of the probe. Thus, the head of the probe can rotate to be positioned displaced relative to the pedestal of the probe. As described below, this is particularly useful when measuring the depth of the anal canal and is important for the surgeon to inject the bulking agent only into the anal canal, not the rectum.

The head portion is rotatable via a handle provided near the open end of the probe.

Preferably, the probe has one or a set of measuring lines for use in measuring the anal canal length on its outer surface.

In one method according to the invention, the surgeon thus inserts the probe into the anal canal and directs the probe so that the groove is positioned adjacent the position to be examined and / or treated. The longitudinally directed position of the terminal closed end of the probe is located about 1 cm from the linea dentalis or the tooth line in the anal canal.

In another method according to the invention, the surgeon inserts the probe into the anal canal so that the head of the probe enters the rectum. The surgeon then rotates the head so that the head is positioned displaced relative to the other part of the probe (the body) (see Figure 7). The surgeon then retracts the probe until the head contacts the distal end of the anal canal (connection to the rectum) and the surgeon reads the measurement line to know the exact length of the anal canal.

When the probe is inserted, part of the tissue of the anal canal, that is, the mucosal tissue, will enter (permeate) the groove of the probe (because of its material properties), where the tissue can be examined and treated. The probe then protects the anal canal or other parts of the rectum to eliminate the risk of damage and infection, while the hollowed part of the probe provides space for the surgeon to inject a device to test the anal canal. The anal canal region in the groove can then be treated by injecting the device into the groove, which is accessible through the opening from the open end of the hollow member.

The probe includes a removable component (close) positioned in the groove to fill the groove, so that the probe has a smooth, continuous exterior upon insertion and movement into the anal canal. Thus, by rotating the probe until the tissue area of treatment is exactly in contact with the groove, the probe can be oriented exactly within the anal canal. The removable component is preferably a member such as a pin having the same cross-sectional shape as the groove.

The probe extends at the open end to ensure that the probe does not slip into the anal canal and rectum, and the probe includes a collar disposed near the open end to form an insertion stop for the probe.

As mentioned, the probe can be rotated within the anal canal to accurately reach the area of tissue to be treated, which is useful when other sites need to be treated. However, the probe may include at least one (two, three, four or more) each extending longitudinally from the sidewalls so that when the probe is inserted into the patient's anal canal, the sites of the patient's anal canal can enter the groove for testing and treatment. It may include the groove of. Because of this, once the probe is placed, it is possible to test and treat various tissue areas without moving the probe within the anal canal.

Preferably, the groove extends substantially from the closed end or the head portion to the open end, although the length may vary. In an embodiment of the probe according to the invention having a rotatable head, the groove preferably does not extend to the rotatable head portion.

In an embodiment, the groove does not extend through the sidewall of the hollow member (ie the groove and the hollow member internal space are not in communication), which is not particularly convenient if the patient has anal canal debilitation (an anal tube is then a hollow space of the probe). ), It is difficult to retract when the volume extender is injected into the tissue.

In the alternative, however, a groove is formed through the side wall such that a portion of the anal canal enters the hollow space of the probe, making it possible to use such a probe for a particular patient.

The distal end of the probe formed near the closed end / head portion preferably has a substantially cone shape to facilitate insertion. In any case, the end closure end is preferably spherical and smooth, including the transition zone from the end portion to the body portion of the hollow member.

The elasticity of the anal canal varies from patient to patient, and in general, the anal canal tissues lose elasticity and loosen as the patient ages. Thus, the dimensions of the probe are dependent on the patient to be treated. The probe (the main body of the probe) is generally cylindrical in shape having an outer diameter between 20 mm and 30 mm, and the groove width is between 1 mm and 5 mm, preferably 3 mm. The length of the probe is preferably between 50 mm and 100 mm.

The open ends and grooves are configured to accommodate surgical instruments for anal canal testing and treatment, such as scopes, ultrasound probes, or needle / insert tubes.

According to another embodiment, the present invention relates to the examination of the anal canal of a mammalian body and the use of a probe for surgical treatment.

According to another embodiment, the present invention relates to a method for treating fecal incontinence comprising the use of a probe. The method includes inserting a probe into an anal canal of a patient and injecting a drug into an area of the anal canal that has entered the groove of the probe.

Prior to the infusion step, the method further comprises rotating the probe until the anal canal region to be tested or treated is aligned with at least one groove of the probe, and retracting the removable component to allow the anal canal region to enter the groove. It may include.

The method further includes, after the insertion step, scanning the anal canal using an ultrasonic probe inserted into the hollow of the probe. The probe is configured to receive an ultrasonic probe in the hollow space, the ultrasonic wave preferably filling the entire hollow space. Thus, through the use of the probe according to the invention it is easy for the surgeon to test the anal canal using an ultrasonic probe.

The method includes rotating the head portion to a position displaced relative to another portion of the probe prior to the injecting step, retracting the probe out of the anal canal until the portion contacts the anal canal tissue forming a junction with the rectum; And measuring the length of the anal canal using the measurement marker provided on the probe surface. Once the length of the anal canal is measured, the head is rotated to a position aligned with the other part of the probe (meaning the outer surface of the hollow of the probe), which can then be withdrawn from the anal canal.

For the treatment of fecal incontinence, the volumetric agent may be a hydrogel, which is injected under the tissue surrounding the anal canal, in particular under the submucosal membrane. 2-6 ml injections are suitable. The hydrogel is preferably dispersed at one or more cross sectional positions along a single longitudinal position of the anal canal. In certain suitable embodiments, three or more reservoirs are made along a single longitudinal position of the anal canal, preferably at 10, 2, 6 o'clock positions on the cross-section of the anal canal.

The bulking agent is preferably injected through a hollow insertion tube inserted through the opening in the open end of the probe and through the grooved tissue.

The groove provides a guiding chute for guiding the instrument along the anal canal tissue to facilitate manipulation of the instrument in the probe and to provide greater accuracy of drug injection into the tissue.

Probes are preferably disposable and are marketed in the form of kits that include materials and materials suitable for injection such as probes and bulking agents and surgical instruments such as injections and needles / insertion tubes for injecting materials.

The probe is preferably made of plastic, and the probe, or at least the groove of the probe, is made of transparent plastic through which light can pass, so that the shadow in the probe is minimized so that the anal canal is more visible.

According to another embodiment, the present invention relates to a probe for insertion into an anal canal of a patient, the hollow tube member having an open end for receiving a surgical instrument, and a head configured to be positioned opposite the opening and inserted into the anal canal. And at least one groove provided in the sidewall of the hollow member and extending longitudinally so that a portion of the patient's anal canal can enter the groove, the groove being adapted for the examination and treatment of the anal canal region. It is accessible through an opening near the open end.

The head portion is formed near the closed end of the hollow member. The head portion is rotatable about an axis of rotation that is substantially parallel to, but not coincident with, the longitudinal central axis of the probe.

The probe according to this last embodiment comprises any of the components mentioned in connection with the first embodiment of the invention.

The words "body" and "patient" are to be understood to include any mammalian body, such as a human.

Preferred embodiments of the present invention will now be described with reference to the attached drawings 1 to 13.

1 to 5 show a first embodiment of a probe according to the invention.

6 to 13 show a second embodiment of a probe according to the invention.

13 to 19 show a third embodiment of a probe according to the invention.

1 to 5 show an embodiment of the probe 1 according to the invention. The probe 1 has an open end, a closed end and an elongated body portion extending therebetween. The body portion of the probe has a circular cross-sectional shape (ie, the body portion is cylindrical) and the closed end is rounded, smooth and substantially cone shaped to facilitate insertion of the probe into the anal canal. The probe is hollow from the open end to the closed distal end. Thus, the elongated body portion constitutes the probe side wall.

The probe includes a groove 4 provided in the side wall. The groove 4 extends longitudinally in the side wall along the probe length. Once the probe is inserted into the anal canal, a portion of the anal canal enters (or is placed / depressed) into the groove 4 so that the surgeon can examine and treat the site through the opening 5 and the hollow space 6 of the probe. To be. This treatment involves the injection of a volumetric agent through an insertion tube inserted through an opening 5 at the widened (tip) open end of the probe, the opening 5 communicating with the groove. The probe is preferably made of transparent plastic, making it easier to see the anal canal in the hollow space of the probe.

The probe 1 includes a widened portion or collar 7, at its open end, forming a " insertion stop " of the probe.

6 to 13 show a second embodiment in which the probe 1 comprises a rotatable head portion 8. The head portion 8 rotates about an axis of rotation which is parallel but not coincident with the longitudinal axis of the probe.

The head 8 is rotated by a handle 9 provided at the open end 2 of the probe 1. The handle is connected to the head via a shaft 10 suspended in a tube 11 provided in the hollow of the probe. 6 and 8 to 11 show the probe with the head aligned with the pedestal of the probe 1, and FIG. 7 shows the probe with the head rotated and in a displaced position with respect to the pedestal of the probe 1 To show.

Figures 12 and 13 show the probe of Figures 6-11 including measurement markers / measuring lines on the outer surface for measuring the length of the anal canal.

14 and 15 show perspective views of the probe from the distal end and the distal closed end, respectively, according to another embodiment of the invention. The probe according to this embodiment is also shown in a side view in FIG. 15 and in an end view (observed from the open tip end 2) in FIG. Figure 18 shows a side cross sectional view of the probe (taken along line A-A in Figure 16). FIG. 19 shows a cross section through the body of the probe 1 (taken along line B-B in FIG. 18).

The probe of this embodiment is similar to the probe described in connection with FIGS. 1-7 in many respects, including the choice of shape and material. The same reference numerals are used for the same parts / components in the entire drawing.

In this embodiment (Figs. 14-19), the probe 1 has three grooves 4a, 4b and 4c, and a modified stop 7 compared with the embodiment shown in Figs. . The grooves extend in a direction parallel to the longitudinal axis of the probe as in the case of the above-described embodiment. While the body wall thickness of the probe 1 shown in Figs. 1-13 is thick enough to have a groove 4, in this embodiment the wall thickness is reduced to improve visibility, so that the surgeon can It is easy to see whether some tissue of the wall has dropped / depressed into the grooves 4a, 4b, 4c. Thus, as can be understood from Fig. 19, the grooves bulge into the space formed in the side wall of the body portion of the probe.

In the illustrated embodiment, the openings 5a, 5b, 5c of the open end stop 7 of the probe further comprise guides 12a, 12b, 12c for each opening 5a, 5b, 5c. The guides 12a, 12b, 12c are used for the purpose of guiding surgical instruments such as syringes and needles / intubation tubes, and the guides 12a, 12b, 12c preferably have distal ends of syringes or other injection means. A Luer connection or other suitable connection means configured to receive the pressure gauge and sized to allow the injection cannula / tool to enter the grooves 4a, 4b, 4c through the opening 5.

The reduced wall thickness also applies to probes with one, two, four or other grooves.

The reduced wall thickness also applies to probes with stops 7 of different shapes, for example those shown in the figures 1 to 13.

The guides 12a, 12b, 12c also have openings 5 in the embodiment or other embodiment described above with reference to Figs.

Claims (25)

A probe inserted into the anal canal of the patient, A hollow tube member disposed opposite the closed end configured to enter the anal canal and having an open end for receiving a surgical instrument, At least one longitudinally extending groove provided in the side wall of the hollow member to allow a portion of the patient's anal canal to enter therein, A widening portion or collar disposed near said open end, Said groove being accessible through an opening formed through said dilator or collar for examination and treatment of said portion of said anal canal. The method of claim 1, And a head portion formed at the closed end, the head portion being rotatable about a rotation axis parallel to but not parallel to the longitudinal central axis of the probe. The method of claim 2, Probe for insertion of the anal canal including a handle adjacent the open end for rotating the head portion. The method of claim 3, The handle is an anal canal insertion probe connected to a rotatable head portion through a shaft suspended inside the hollow tube member. The method of claim 1, A probe for insertion of an anal canal including a removable component located in the groove to fill the groove during insertion or movement of the probe within the anal canal. The method of claim 1, And said dilator or collar disposed adjacent said open end forms an insertion stop of said probe. The method of claim 1, Comprising two to four grooves distributed along the periphery of the hollow member, Each groove extends longitudinally in the side wall to allow a portion of the patient's anal canal to enter the groove for examination and treatment. The method of claim 1, Probe for insertion of an anal canal with a closed end having a cone shape to facilitate insertion. The method of claim 1, The probe is a cylindrical anal canal insertion probe having an outer diameter of 20mm to 30mm. The method according to claim 1 or 7, The groove is an anal canal insertion probe extending from the closed end or the head to the open end. The method of claim 10, A groove insertion probe having a width of 1 mm to 5 mm. The method according to any one of claims 1 to 9, The surgical instrument includes a scope, an ultrasound probe, and a probe for inserting an anal canal that includes one or more of a needle. The method according to any one of claims 1 to 9, The probe is a probe for inserting an anal canal made of plastic. The method of claim 13, A probe for insertion of an anal canal or at least a groove made of transparent plastic. The method according to any one of claims 1 to 9, An anal canal insertion probe including a measuring line on the outer surface for measuring the length of the anal canal.  i) the probe according to any one of claims 1 to 9, ii) a substance suitable for injection into the human body, iii) a kit comprising a surgical instrument for injecting the substance. The method of claim 10, A groove insertion probe having a width of 3 mm. The method of claim 1, And said groove does not extend through the side wall of said hollow tube member. The method of claim 1, The groove is an anal canal insertion probe disposed in the side wall to prevent material communication between the groove and the hollow tube member internal space. The method of claim 1, And an opening through said widening portion or collar is arranged to guide an injection cannula along said groove. The method of claim 1, The hollow tube member has a longitudinal axis and the opening through the widening portion or collar is arranged to guide the injection insertion tube parallel to the longitudinal axis of the hollow tube member. The method of claim 8, The groove is an anal canal insertion probe extending to the closed end of the cone shape. The method of claim 1, A guide for guiding an injection insertion tube is provided in connection with the opening through the widening portion or the collar. 24. The method of claim 23, The guide portion for guiding the injection insertion tube is an anal canal insertion probe extending from the widening portion or the collar to the tip side. delete

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