WO2009150130A1

WO2009150130A1 - Device for diagnosis of internal tissue

Info

Publication number: WO2009150130A1
Application number: PCT/EP2009/057045
Authority: WO
Inventors: Michaela Abrahamowicz
Original assignee: Gerhard Pejcl Medizintechnik Handels Gmbh
Priority date: 2008-06-12
Filing date: 2009-06-08
Publication date: 2009-12-17
Also published as: AT506842B1; AT506842A1

Abstract

Device for taking pictures and for measurement of internal tissue consisting of an expandable funnel (1) with a calibrated distance between both ends (2, 3), wherein one end is flexible, and also a set with an insertion instrument.

Description

Device for the diagnosis of internal tissue

The invention relates to a device for recording and measuring of internal tissue, in particular a device for determining the internal rectal prolapse.

In an external rectal prolapse, which is also referred to as a rectal episode, the rectum comes out of the anus, because among other things, the suspension of the colon in the region of the sacrum loosens. An internal rectal prolapse is an event located inside the rectum and also includes precursors of an external rectal prolapse. At the same time there is often damage to the rectal wall with anal incontinence. Increased pressing leads to leakage of the rectum. The cause is usually a long-standing constipation, which leads to further changes of the rectum. The occurrence of hemorrhoids is the first indication of an onset of anal prolapse.

So far, the following diagnostic methods of an internal prolapse are performed by default: (i) Introduction of a finger of the examiner in the anus and rectoanal transition. However, this procedure is only an approximate assessment, requires appropriate experience of the examiner and is not reproducible or documented.

(ii) defecography (stool removal x-ray) with contrast of vagina, bladder, small intestine and rectum in video recording. However, this examination is stressful for the patient and expensive for the examiner.

(iii) The measurement of the internal rectal prolapse can currently only be done intraoperatively by means of a circular anal dilator.

There is no endoscopic examination that, under direct vision, represents the internal prolapse because the lumen of the endoscopes is too narrow.

WO2006 / 046263 describes a diagnostic apparatus consisting of an elongated tubular rod of e.g. vaginal or anal can be introduced. The distal end of the device can be opened, thus keeping a window open to introduce an endoscope and visually examine any pathologies.

US2007 / 0249901A1 describes a radio-frequency-labeled instrument that can be introduced into the anal canal. A reading device connected to an antenna can perceive a change in the signals due to the change in the position of the rod, whereby the position of the rod can be determined. US5279548 describes a method which can be used for operations in the peritoneum or in the pelvic cavity of a female patient. After vaginal insertion of a trocar, a membrane can be opened at the distal end to serve as a safety device during surgery. The diagnostic methods of the prior art are sometimes expensive and associated with a large burden on the patient.

The object of the invention is to provide an improved diagnostic device which allows for accurate detection of internal rectal prolapse, pelvic floor depression, and determination of Douglas depth with little patient stress.

The object is achieved by the subject matter of the invention.

The invention describes a device for receiving and measuring internal tissue, comprising an expandable funnel with a calibrated distance between both ends, one end being flexible. The device according to the invention makes it possible for the examiner to carry out a simple, reproducible and documentable outpatient examination for the precise diagnosis and differential diagnosis of internal tissue, largely without stress for the patient. "Inner tissue" is understood to mean cell aggregates located within the human or animal body, in particular growths, polyps, cysts, skin protuberances and the like.

The device may be used for postoperative therapy evaluation as well as preoperatively or in routine examinations to examine patients or healthy subjects at increased risk of tissue failure. However, the device can also be used generally to measure tissue protuberances within a body orifice of a human or animal body, in particular for internal measurement of the abdomen, in order, e.g. to detect an internal rectal prolapse or a pelvic floor depression, and also to measure the Douglas depth. For this purpose, the device is also referred to as a "colorectal stent." For invasive measurement, the device of the invention will be introduced into body orifices, such as the anal canal.

It was found that with the device according to the invention the defecography (ie stool emptying X-ray) with contrasting of vagina, bladder, small intestine and rectum could be improved in video recording or possibly replaced, and thus a lower radiation exposure for the patient could be achieved. The calibration of the funnel serves to measure the tissue which can be taken up in the funnel. For this purpose, the device according to the invention preferably has calibrated markings on the funnel which form a scale. Calibrated markers are markers that are placed in a defined spatial distance from each other. Preferably, markings are provided, for example color markings, which can be detected with imaging measures in order to enable dimensional or position determination. A marker in the sense of the invention is a signal which is determined by physical / chemical methods. This allows the internal tissue to be picked up and measured, preferably by optical or radiological methods.

Preferably, radiological and / or endoscopically recognizable color marking are attached to the device according to the invention. The markings are conceivable at different positions of the device according to the invention. In any case, the attachment of at least two markings at a certain distance is preferred. Preferably, the markings are attached to at least three positions on the device according to the invention. For example, markers are attached to the flexible end of the funnel, at the opposite end and optionally in the center of the funnel. In the minimal version, the device can only be a funnel (see FIG. 1 a) with a flexible end. Preferably, the end is fixed relative to the flexible end and is also designed as a rigid end. This opposite end of the flexible end is also referred to here as a "rigid end".

The shape of the flexible end is variable in that the funnel is expandable or retractable, such as a self-expandable funnel which automatically unfolds upon insertion of the device into the body opening. The device according to the invention is usually introduced in the unexpanded state in the interior of the body, and then expanded the funnel. Preferably, the flexible end has a larger one in the expanded state

Diameter as the diameter of the opposite end.

By appropriate measures, such as contraction of the funnel with a corresponding device, the funnel can be made smaller, which facilitates the execution of the diagnostic device. The funnel can also be designed in this way be that it contracts by itself in the course of carrying out the device according to the invention. A preferred embodiment relates to a device which in the closed state has a smaller diameter than the diameter of the opposite end. The funnel according to the invention is preferably continuous and so, for example, an endoscope can be inserted through one end of the funnel and re-executed through the other end of the funnel.

The rigid end of the funnel is preferably connected to a tubular element. The cross-section of the tubular element may represent a suitable geometric shape, preferably mostly circular, elliptical, square, or rectangular. Likewise, the funnel or stent according to the invention in a preferred embodiment may be circular, elliptical, square, or rectangular. The tubular element may also have markings corresponding to the internal dimension or a scale. The tubular element is preferably designed as a flexible element.

In a particularly preferred embodiment, the tubular member is of a braid. Preferably, the tubular member comprises a plastic mesh. A preferred apparatus comprises a funnel according to the invention with a tubular element, both consisting of a mesh. The braid according to the invention has high flexibility in a particular embodiment.

The device according to the invention is preferably made of metal or plastic, in particular of a material that can be sterilized by chemical or physical measures. Preferred materials for the device according to the invention are precious metals, or the materials Nitinol or stainless steel. In any case, it is preferable to use an inert material.

The device according to the invention can additionally with a plastic membrane, such. As polyurethane, silicone or Teflon, be coated to facilitate removal of the stent from the patient after completion of the investigation. The device can be designed for multiple use or as a disposable device. Reusability can be ensured by adhering to the disinfection and / or sterilization guidelines applicable to medical instruments. In a preferred embodiment, the device according to the invention has at least one thread, which facilitates the removal of the device. Constrictable threads are particularly preferred, which are attached to the device, whereby the device after examination can be pulled out of the body opening again. For this purpose, in a preferred embodiment, a thread at the flexible end of the funnel, optionally also another thread at the rigid end of the funnel and / or attached to the tubular member of the device. In each case several threads can be attached to the funnel and / or to the tubular element. By pulling on a thread, if necessary, the funnel-shaped end is contracted in order to achieve a reduction in the diameter, and to facilitate removal of the device.

As a thread and twisted threads can be used. In a particularly advantageous embodiment of the invention, a thread at or near the flexible end of the funnel, and / or a thread at or near the rigid end of the funnel and / or optionally attached to or near the tubular member of the device. In a particularly advantageous embodiment, a thread at the flexible end of the funnel serves to retract the flexible end of the funnel and thus to reduce the diameter of the flexible end in order then to be able to remove the device according to the invention in a gentle manner from the body. For the introduction of the device according to the invention advantageously an insertion device is used, which places the device according to the invention at the place of measurement. Accordingly, a kit according to the invention is provided which comprises a) an apparatus according to the invention, and b) an introduction instrument.

An insertion device or insertion instrument, also called a laying instrument, is a suitable device which serves for the placement of the device according to the invention. The introducer tool can also ensure that the anal canal is kept open while the stent is placed in the body.

Preferably, the device is inserted into the anus under finger insertion, 3 cm deep at the rectoanal junction, and released there with the aid of the laying instrument (near the suspected tissue anomaly). For example, the introducer can also transanal introduced by a proctoscope, at the rectoanal transition under released proctoscopic view, it expands by itself and keeps the anal canal open. By reinserting the proctoscope in the stent lying is the

Extent of distal prolapse visible.

Preferably, an insertion instrument is constructed so that it can be connected to the device via a plug-in device. Preferably, the

Diameter of the insertion instrument at the end for receiving the device smaller than the diameter of the device.

A preferably used insertion instrument comprises a handle and a tube, which is optionally transparent on the outside. The handle preferably has a safety device which is premature inadvertent

To prevent the funnel from opening during the insertion or laying process, via a release handle and a handle end.

The dimension of the introduction tool depends on the intended use. For rectal use, a suitable diameter for insertion into the rectal canal is chosen. The length should at least be suitable for the device in the

Body opening, e.g. to position in the intestine. Preferably, the length of the

Introducer 10 to 40 cm, more preferably 15 to 30 cm working length.

The preferred dimensions of the device according to the invention are also dependent on the intended use. In a preferred embodiment for rectal use, the funnel is at least 0.5 cm, preferably at least 1 cm long, with an outer diameter of at least 3 cm, preferably at least 4 cm, preferably up to 6 cm in the open state. The diameter of the rigid

The funnel end or the preferred tubular extension is preferably smaller than the diameter of the funnel in the opened state, preferably at least 2 cm, more preferably at least 4 cm. The length of the tubular

Elements is preferably at least 2 cm, more preferably at least 3 or at least 4 cm, preferably up to 5 cm. Brief Description:

Fig. 1 shows the colorectal stent for the diagnosis of an internal rectal prolapse, a pelvic floor depression and for determining the Douglas depth, which consists of a flexible, self-expandable, tubular metal braid (1) with a straight end (2 ) and a funnel-shaped end (3). The funnel-shaped end (3) has radiologically and endoscopically recognizable color markings (6) at the beginning and at the outermost edge. At the straight end (2) a thread (5) are attached to the left and right sides.

Fig. 1a shows the colorectal stent as a funnel in the expanded state. Fig. 2 shows the introducer (6) with which the colorectal stent is transanal introduced in the unexpanded state.

Fig. 3 shows the released from the introducer (6) and self-expanded colorectal stent.

Fig. 4 shows how the colorectal stent is removed by pulling on the threads (5) at the straight end (2).

Fig. 5 describes the insertion instrument, which consists of a handle (7) and a transparent outer tube (8). The handle has a safety screw (7a) intended to prevent premature accidental release of the colorectal stent during the insertion process via a release handle (7b) and a handle end (7c).

Fig. 6 depicts the process of delivering the colorectal stent, which first begins by unscrewing the safety screw (7a) and terminating with the withdrawal of the release handle (7b) in the proximal direction until it stops against the handle end (7c). Upon reaching the end of the handle, the colorectal stent is released from the introducer.

Fig. 7 describes the markings on the insertion instrument. The mark 1 on the outer tube (10) indicates the beginning of the 1 cm long funnel-shaped end (3) within the Einführinstrumentes. The marker 2 on the outer tube (9) is 12 cm away from the distal end of the introducer. The introducer is inserted transanal to the mark 2 (9) through a proctoscope into the patient. During the release process by retracting the release handle (7b), reaching the mark on the handle of the insertion instrument (11) indicates that the 1 cm long funnel-shaped end (3) has been released.

Fig. 8 shows the dimensions of the exemplary colorectal stent Fig. 9 shows the dimensions of the exemplary laying instrument.

Aufzählung and short description of the drawing figures in the sketches

(1) Flexible, self-expandable, tubular metal braiding made of the material Nitinol or stainless steel (alternatively also made of a plastic)

Mesh), covered with a plastic membrane of polyurethane, silicone or Teflon

(2) straight end

(3) funnel-shaped end (4) radiological and endoscopic color markings at the beginning and at the outermost edge of the funnel-shaped end

(5) 1 thread each on the left and right sides of the straight end

(6) Plastic insertion instrument

(7) Handle of the insertion instrument (7a) Security screw of the handle

(7b) Release handle

(7c) handle end

(8) transparent outer tube

(9) Mark 1 on the outer tube (10) Mark 2 on the outer tube

(11) Mark on the handle of the insertion instrument

The invention will be further described by the following examples.

Examples

1. Description of a colorectal stent for the diagnosis of an internal rectal prolapse, a pelvic floor depression and for the determination of the Douglas depth

The colorectal stent consists of a flexible, self-expandable, tubular metal braid made of nitinol or stainless steel or alternatively of a plastic braid (1) with a straight end (2) and a funnel-shaped end (3). The entire colorectal stent is additionally encased with a plastic membrane (such as polyurethane, silicone, or teflon) to aid removal of the stent from the patient after completion of the study facilitate. The funnel-shaped end (3) has radiologically and endoscopically recognizable color markings (4) at the beginning and at the outermost edge. At the straight end (2) on the left and right side each have a 14 cm long thread (5) attached. The colorectal stent is transanal introduced in the unexpanded state with the aid of a plastic insertion instrument (6) and released in the rectoanal transition. After the release and self-expansion of the colorectal stent, with the aid of the funnel-shaped end (3) and the color markings (4) under radiological fluoroscopy and / or under endoscopic view, the diagnosis of an internal rectal prolapse and pelvic floor depression and Determination of Douglas depth can be made.

The colorectal stent is introduced transanal through a proctoscope in the unexpanded state with the aid of a plastic introducer (6), released at the rectoanal junction under a proctoscopic view, expands by itself and thereby keeps the anal canal open by reintroducing the proctoscope into the The extent of the distal rectal prolapse is visible in the colorectal stent. Specifically, the funnel-shaped end (3) with the two endoscopically recognizable color markings (6) allows the diagnosis and differential diagnosis and measurement of the internal rectal prolapse. The measurement of the rectal prolapse offers the advantage that a precise stapler selection can be made before the operation for the treatment of rectal prolapse.

Furthermore, due to the funnel-shaped end (3) and the two radiographically recognizable color markings (6), the colorectal stent allows a representation of the rectoanal transition in native x-ray (without contrast medium), the detection of a pelvic floor depression with contrast of the vagina and corresponding contrasting of the small intestine, the representation of an enterocele.

After completion of the examination, the colorectal stent is removed from the patient. To remove the stent from the rectoanal transition, pull on the left and right sutures (5) of the straight end (2).

The implantation period of the colorectal stent for the diagnosis of an internal rectal prolapse, a pelvic floor depression and for the determination of the Douglas depth is only the duration of the examination (about 5 to 15 minutes). Subsequently, the stent is removed again.

The examinations are performed on an outpatient basis without the use of anesthesia. 2. Medical application

Preliminary examinations a) Survey of the history after obstipation score to Longo,

Wexner incontinence scores b) Examination of the patient on the gynecological chair c) Examination together with the gynecologist

Result of examination with the colorectal stent

The result of the examination should be a diagnostic result consistent with the medical history according to Longo's ODS symptom score of> 7 (ODS stands for Obstructed Defecation Syndrome) and the status according to the physical examination of the patient. In patients who have been admitted with a problem of constipation, depression, or a hemorrhoid problem and who have undergone surgery or conservative treatment, treatment success before and after surgery, and before and after conservative treatment with Longo ODS symptom score, is assessed measured. The symptom score may correspond to a corresponding internal rectal prolapse or the symptom score may be predictive. A score of> 7 is usually associated with an internal rectal prolapse and / or a pelvic floor depression and / or a deep Douglas. The determination of a possible internal rectal prolapse, a pelvic floor depression or a Douglas depth with the help of the colorectal stent during the examination can thus be confirmed with an ODS symptom score of> 7. However, the symptom score alone does not allow for conclusions about the extent of internal rectal prolapse, pelvic floor depression, or Douglas depth.

Procedure of the examination - diagnosis of the rectal prolapse The patient is on the basis of taking anamnesis and digital examination on

Gynstuhl, as well as after signing the consent, examined with the proctoscope. Thereafter, via the proctoscope, the inner lumen was previously provided with lubricant, introduced the introducer, set the colorectal stent and again advanced the proctoscope in the stent, so that on all sides of the Prolapse and its extent can be seen and measured. This takes about 5 minutes.

Presentation of the rectoanal transition and internal prolapse in native X-ray; Demonstration of pelvic floor depression, cvstocele and presentation of an enterocele

3 hours before the examination, the patient drunk Prontbario powder, dissolved in 250 ml of water. Then the patient is taken to the x-ray for X-ray examination, the colorectal stent is placed in situ and there on the x-ray bed in left lateral position:

It is introduced through the colorectal stent 200 ml Prontobarium by means of a disposable female catheter in the distal sigmoid (contrast agent is diluted with water 1: 1). Then - in supine position - Add 20 ml of contrast medium into the vagina. Then the patient sits down on the X-ray toilet to take a video recording with the following sequences: pinching - let loose - pressing to subjective complete emptying. The contrast medium application lasts approx. 5 min. And the X-ray image with pinching - allow to relax and emptying - another 2 minutes. There are 3 still images made: starting position at rest, the end of the pressing process and the end of the rest position after the pressing process. For the sole determination of a deep Douglas, it is not necessary to fill the rectum with contrast agent.

release process

Before starting the placement or release process, the inner lumen of the proctoscope is provided with lubricant. Subsequently, the insertion instrument (6) is introduced transanal to the mark 2 (9) by a proctoscope in the patient. The safety screw (7a) is screwed on and the release handle (7b) is retracted in the proximal direction. Upon reaching the mark on the handle of the insertion instrument (11) the 1 cm long funnel-shaped end (3) is released. Thereafter, retraction of the release grip (7b) in the proximal direction continues until it stops on the handle end (7c). Upon reaching the end of the handle, the colorectal stent is completely released from the introducer in the recto-anal transition. Now you can start the actual investigation. Selection of patients

Excluded chapters: Female patients with inflammatory or malignant diseases in the genitourinary tract as well as in the anorectal area or after rectum surgery Female patients suffering from diarrhea Pregnant patients due to the planned X-ray examination Female patients receiving anticoagulant substances such as Marcoumar, antiplatelet agents (aspirin, thrombo-as, Thomapyrin) take serious cardiopulmonary dysfunction

Dysfunction of blood clotting

Contraindication of an endoscopic examination Female patients with a vulnerable colorectal mucosa - with ASA 3 to ASA 4 criteria of the American society of anesthesiologists

Explanations of the ASA criteria

ASA 3: Severe impairment of the general condition or serious illness of various causes, with or without association with the underlying disease to be operated on.

ASA 4: severe and life-threatening general illness with or without association with the underlying condition to be treated.

ASA 5: morbid patient with poor survival; the operation is ultima ratio

inclusion criteria

Female inpatients and inpatients in adult life, nulliparae and multiparae with an ODS symptom score according to Longo of> 7 (ODS stands for Obstructed Defecation Syndrome) with palpable or visible prolapse findings (both rectal and genital) as well as depression findings and deep Douglas ASA 1 - ASA 2 criteria of the American Society of Anaesthesiologists Explanation of the ASA criteria

ASA 1: no organic, physiological, biochemical or psychiatric disorder

ASA 2: mild to moderate impairment of the general condition either by the underlying disease or by other pathological processes.

Benefits related to the use of the product

With regard to the risk-benefit assessment, the special benefit for the patient results in a precise selection, in order to avoid unnecessary surgery, including reduction surgery. With the help of the colorectal stent and the examination method, an accurate detection and measurement of an internal rectum prolapse can be made. In addition, a representation of the rectoanal transition and the internal prolapse in native X-ray, a proof of pelvic floor depression and a representation of an enterocele is possible (with precise documentation). Thus, only those patients with the problem of constipation, depression or a hemorrhoid problem are operated, which are exhausted with a conservative therapy.

Claims

claims:

An apparatus for receiving and measuring internal tissue comprising an expandable funnel with a calibrated distance between both ends, one end being flexible.

2. Apparatus according to claim 1, characterized in that the funnel calibrated

Has markings.

3. Apparatus according to claim 1 or 2, characterized in that the funnel comprises a tubular flexible element.

4. Device according to one of claims 1 to 3, characterized in that the tubular flexible element is made of a braid.

5. Device according to one of claims 1 to 4, characterized in that it is sheathed with a plastic membrane.

6. Device according to one of claims 1 to 5, characterized in that radiologically and / or endoscopically detectable markings are attached to at least two positions.

7. Device according to one of claims 1 to 6, characterized in that the material is made of sterilizable metal and / or plastic.

8. Device according to one of claims 1 to 7, characterized in that it comprises at least one thread, which facilitates the removal of the device.

9. Device according to one of claims 1 to 8, characterized in that the flexible end in the closed state has a smaller diameter than the diameter of the opposite end.

10.Gerät according to one of claims 1 to 9, characterized in that the flexible end in the expanded state has a larger diameter than that

Diameter of the opposite end.

11. Device according to one of claims 1 to 10, for the diagnosis of an internal

Rectal prolapse, pelvic floor depression, and Douglas depth.

12. Set comprising a) a device according to one of claims 1 to 11, and b) an insertion instrument.

13. Set according to claim 12, characterized in that the diameter of the insertion instrument is smaller than the diameter of the device.

14. Set according to claim 12 or 13, characterized in that the

Insertion instrument has a suitable length for positioning of the device in the abdominal cavity.