Ultrasonic rod probe

Abstract

Described is an arrangement with an ultrasonic rod probe for carrying out rectal or vaginal examinations, having a distally rounded probe head, at least in which an ultrasonic transducer is integrated. The invention is distinguished by the fact that attached to the probe head is at least one pressure-sensitive element which, in response to mechanical contact with an object, undergoes deformation when a pressure acting between the pressure-sensitive element and the object is exceeded.

Description

[0001] Ultrasonic rod probe

[0002] Technical area

[0003] The invention relates to an ultrasound probe for conducting rectal or vaginal examinations, comprising a probe head rounded at the distal end, into which at least one ultrasound transducer is integrated. A common clinical picture in urology concerns enlarged prostate glands in men (BPH, benign prostatic hyperplasia). Enlargement of the prostate gland, also known as the prostate, leads to a narrowing of the urethra, which can lead to difficulty urinating or complete urinary retention (ischuria). Drug-assisted treatment options exist for the early stages of benign prostatic hyperplasia. For more advanced BPH, which is associated with significant symptoms or complications, surgical interventions are usually the solution.

[0004] Various surgical methods can be used for advanced prostate treatment. One of these methods uses the abrasive effect of a water jet, which ablates the benign hyperplasia (adenoma) of the prostate using a focused, high-pressure water jet. To determine the shape and size of an adenoma to be removed, the surgeon inserts an ultrasound probe rectally and guides it to the site of the prostate.

[0005] Image processing software calculates the area to be treated based on the images obtained with the ultrasound probe and controls the therapeutically effective water jet. During surgical preparation, the surgeon must repeatedly readjust the ultrasound probe, i.e., rotate it, move it distally and / or proximally, and / or laterally / medially.

[0006] During insertion of the ultrasound probe, as well as during subsequent advancement or retraction, there is a risk of injury to the intestine, especially if the ultrasound probe is positioned at a Kohlrausch fold. A resulting rupture of the intestinal wall can have various consequences: a) Injury to the intestinal wall with a perforation into the peritoneal space can lead to serious infections, including sepsis and death. b) Injury in the pararectal / paravesical space can cause local discomfort, such as a painful abscess, which can take several months to heal.

[0007] Such injuries must be avoided during examination and handling with ultrasound probes.

[0008] State of the art

[0009] The document DE 69913936 T2 describes an ultrasound probe with a detachable needle guide for taking tissue samples, which provides two scanning ultrasound transducers on the distal, dome-shaped probe head, through which a hollow channel also runs, the longitudinal axis of which is oriented obliquely to the longitudinal axis of the ultrasound probe and which serves to insert a biopsy needle.

[0010] German patent document DE 39 29 611 A1 discloses an intracavitary ultrasound probe, particularly for use in rectal examinations. At the distal end of the probe, an ultrasound transducer is mounted so that it can move around two spatial axes and can be pivoted spatially via manually operated drive axes. The ultrasound transducer is also enclosed in an ultrasound-conductive housing with a rounded surface.

[0011] EP 0 589 082 B1 discloses a prostate probe for generating cross-sectional images of the examination area. A pivoting, convex, semicircular transducer array is attached to the distal probe area.

[0012] Document EP 2 403603 B1 discloses a transurethral ultrasound probe for treating the prostate, comprising an ultrasound transducer assembly mounted within a probe housing for rotation in the probe's longitudinal direction. For acoustic coupling of the transducer assembly to the probe housing, the probe is perfused with a cooling and acoustic coupling fluid. Document EP 2 872 045 B1 discloses an ultrasound probe with an aligned needle guidance system, comparable to the ultrasound probe described above in document DE 699 13 936 T2.

[0013] US 2010 / 0168567 A1 discloses a device and a method for protecting body cavity walls during thermal ablation of tissue near the body cavity. For this purpose, a sheath made of elastic material, through which a warming fluid can flow, is applied around the ultrasound probe. This sheath also possesses acoustic properties that can transmit sound. The additional sheath provides a vent opening at the distal end of the ultrasound probe, through which air pockets between the sheath and the ultrasound probe can escape.

[0014] The document EP 1 455 885 B1 discloses a catheter balloon for the therapeutic modification and positioning of tissue, which is arranged proximally to the distal tip of the catheter and, in the dilated state, projects radially beyond the catheter in order to position it within the vessel by supporting it on the vessel wall.

[0015] All known ultrasound probes suitable for performing rectal or vaginal examinations, in particular for the purpose of prostate detection and measurement, have the disadvantage that there is a high risk of mechanical injury to the vessel wall, particularly during the insertion process, which so far can only be reduced by the great experience and sensitivity of the treating surgeon.

[0016] When using a focused, high-pressure water jet to ablate prostate tissue, the pelvic floor is additionally mechanically immobilized by the endoscope inserted through the urethra, significantly limiting the mobility and thus the ability of the anatomical structures, including the rectum, to move freely in the male pelvis. This increases the risk of injury during the insertion of a transrectal ultrasound probe. Description of the invention

[0017] The invention is based on the object of developing an arrangement with an ultrasound rod probe for carrying out rectal or vaginal examinations with a probe head rounded on the distal side, in which at least one ultrasound transducer is integrated, so that the risk of injury explained above is to be significantly reduced, in particular during the intracorporeal introduction and positioning of the ultrasound probe.

[0018] The object underlying the invention is achieved by an ultrasound probe according to claim 1. Features that advantageously further develop the inventive concept are the subject of the subclaims and can be derived from the following description, in particular from the exemplary embodiments explained in the figures.

[0019] The arrangement according to the solution with an ultrasound rod probe for carrying out rectal or vaginal examinations with a probe head rounded on the distal side with the features of the preamble of claim 1 is characterized in that at least one pressure-sensitive element is attached to the probe head, which is subject to deformation by mechanical contact with an object when a pressure acting between the pressure-sensitive element and the object is exceeded.

[0020] The deformation properties of the pressure-sensitive element must be specified in such a way that, upon interaction with the object, which in the specific application corresponds to a biological vessel wall, in particular the intestinal wall, the pressure-sensitive element can be deformed by the resulting resistance force before any mechanically induced damage occurs to the object, i.e. the intestinal wall. The pressure-sensitive element, which preferably protrudes distally above the sensor head, can preferably be assigned a modulus of elasticity, or E-modulus for short, which is lower or smaller than the modulus of elasticity assigned to the object, preferably the intestinal wall, so that the risk of injury can be significantly reduced simply by selecting a suitable material for the pressure-sensitive element.

[0021] In order to inform the surgeon in a timely manner of any impending risk of damage or injury to the intestinal wall, the event of the incipient and ongoing deformation of the pressure-sensitive element must be communicated to the surgeon in a physiologically perceptible manner, so that the surgeon can vary or interrupt the insertion process of the ultrasound probe. This physiological notification of the surgeon can be achieved in various ways. In the simplest case, the person perceives the contact and the associated resistance-induced elastic deformation of the pressure-sensitive element simply by an increase in the thrust force acting along the ultrasound probe and required for the insertion process. In this case, the person can interrupt the insertion process.However, this requires that the pressure-sensitive element has a length that extends distally beyond the probe head to ensure a deformation path for the pressure-sensitive element that is sufficiently long for the person and their average reaction time. A preferred embodiment in this regard provides an elastomer means attached to the distal end of the sensor head, preferably in the form of a web-like, flexurally elastic extension that extends distally beyond the probe head. For this purpose, the elastomer means typically has a maximum length of 3 cm.

[0022] As an alternative to, or in combination with, the aforementioned elastomeric means, a gel cushion or gel body attached to the distal probe head serves as a pressure-sensitive element, through which the contact event between the distal probe head and an intracorporeal object, preferably the intestinal wall, can be physiologically perceived by the person through a noticeable increase in the thrust force, even before intracorporeal damage occurs. In addition to the thrust force that increases upon contact between the probe head and the intestinal wall, both the elastomeric means and a gel cushion or gel body can serve to ensure gentle and improved gliding of the probe head along the intestinal wall, particularly along a Kohlrausch fold.

[0023] Another alternative to the design of a pressure-sensitive element and its attachment to the probe head is an electrically operable pressure sensor, the sensor signals of which can be transmitted to a signaling device arranged proximally on the ultrasound rod probe, which is capable of generating an optical, acoustic and / or haptically perceptible signal that attracts the person's attention.

[0024] Regardless of the type and design of the at least one pressure-sensitive element, it is advisable to integrate the at least one pressure-sensitive element as an integral component in or on the probe head, either inseparably or detachably and firmly to the probe head using a suitably selected fastening means. A preferred fastening means is at least one elastomeric, condom-like cover enclosing the probe head, into which the at least one pressure-sensitive element is integrated, or between which the at least one pressure-sensitive element is arranged and the probe head.

[0025] Brief description of the invention

[0026] The invention is described below, without limiting the general inventive concept, using exemplary embodiments with reference to the drawings. They show:

[0027] Fig. 1 Example with flexible element on the probe head,

[0028] Fig. 2 Example with gel cushion on the probe head and

[0029] Fig. 3 Embodiment with pressure sensor on the probe head. Ways of implementing the invention, industrial applicability

[0030] Figure 1 schematically shows the distal region of an ultrasound rod probe 1 with at least one ultrasound transducer 2. The ultrasound rod probe 1 has a rounded probe head 3 to which a pressure-sensitive element 4 in the form of an elastomer nipple 5 is attached. The elastomer nipple 5 has a length 6 projecting distally above the probe head 3, which should preferably not exceed three centimeters. The elastomer nipple 5 can be web- or rib-like, or have a different shape that does not counteract the flexibility of the elastic modulus inherent in the elastomer material. In the illustrated embodiment, the nipple shape of the pressure-sensitive element 4 widens from its distal end towards the probe head 3 and approximately assumes the diameter of the probe head.

[0031] To attach the elastomer nipple 5 to the probe head 3, it is possible, on the one hand, to join the elastomer nipple 5 directly to the probe head 5 by means of an adhesive bond. Alternatively, it is possible to loosely fit the elastomer nipple 5 to the probe head 3 and to firmly join it relative to the probe head 3 using a condom-like cover 7, the length, shape, and diameter of which are essentially adapted to the distal region of the ultrasound rod probe 1.

[0032] It is also conceivable to design the elastomer nipple 5 as an integral unit with the condom-like cover 7, which is to be slipped over the ultrasound rod probe 1 before it is used.

[0033] The pressure-sensitive element 4, designed as an elastomer nipple 5, ensures that when the ultrasound rod probe 1 is advanced along the intestine, the elastomer nipple 5 both pushes the wrinkled skin aside upon contact, for example, with the Kohlrausch fold and also pushes the ultrasound rod probe 1 away from the intestinal wall upon further advancement through the intestine. In Figure 2, instead of an elastomer nipple 5, a gel cushion 8 is arranged on the probe head 3 as a pressure-sensitive element 5. The gel cushion 8 corresponds to a soft, compliant mass, typically in the form of soft silicone or a gel-filled bag. When the soft mass comes into contact, it deforms when pressed against an intracorporeal resistance, such as a Kohlrausch fold, whereby the ultrasound rod probe 1 is pushed away from the resistance.

[0034] The gel cushion 8 can be attached directly or indirectly to the probe head 3 in the same way as the elastomer nipple 5 described above.

[0035] Figure 3 shows an embodiment in which the pressure-sensitive element 4 is designed in the form of one or more pressure sensors 9. The at least one pressure sensor 9 is preferably arranged as an integral component in or on the probe head 3 of the ultrasound rod probe 1. For the electrical supply and discharge of the sensor signals, the pressure sensor 9 is connected via an electrical signal line 10 both to a power and control unit (not shown in detail), but in particular also to a signaling means 11 arranged on the proximal side of the ultrasound rod probe 1. When the pressure sensor 9 responds, a signal is forwarded to and activated by the signaling means 11 arranged on the proximal side, whereby the person operating the ultrasound rod probe 1 is alerted by perceiving a visual, acoustic and / or haptic signal.

[0036] A purely mechanical pressure pickup and pressure-dependent proximal-directed signal transmission to alert the person is also conceivable. Such a purely mechanical pressure system provides a fluid reservoir arranged on the probe head 3. Upon the occurrence of a distally directed pressure effect, the fluid is preferably pressure-sensitively forced through a tube running proximally along the ultrasound probe 1, and is detected extracorporeally by the person.

[0037] Ultrasonic rod probe

[0038] Ultrasonic transducer

[0039] Probe head pressure-sensitive element

[0040] Elastomer nipple

[0041] Length of the elastomer nipple

[0042] coating

[0043] Gel cushion

[0044] pressure sensor

[0045] Signal line

[0046] Signaling device io

Claims

Patent claims 1. Arrangement with an ultrasound probe (1) for performing rectal or vaginal examinations with a distally rounded probe head (3), at least in which an ultrasound transducer (2) is integrated, characterized in that at least one pressure-sensitive element (4) is attached to the probe head (3), which is subject to deformation by mechanical contact with an object when a pressure acting between the pressure-sensitive element (4) and the object is exceeded.

2. Arrangement according to claim 1, characterized in that the at least one pressure-sensitive element (4) is one of the following elements: pressure sensor (9), gel pad (8), elastomer nipple (5).

3. Arrangement according to claim 1 or 2, characterized in that the at least one pressure-sensitive element (4) is integrated into or on the probe head (3).

4. Arrangement according to one of claims 1 to 3, characterized in that an elastomeric condom-like covering (7) encompassing at least the probe head (3) is provided.

5. Arrangement according to claim 4, characterized in that the at least one pressure-sensitive element (4) is integrated into the coating (7).

6. Arrangement according to claim 4 or 5, characterized in that the at least one pressure-sensitive element (4) is arranged between the probe head (3) and the coating (7).

7. Arrangement according to one of claims 1 to 6, characterized in that the at least one pressure-sensitive element (4) has a modulus of elasticity that is smaller than a modulus of elasticity that is that of a biological can be attributed to the vessel wall.

8. Arrangement according to one of claims 2 to 7, characterized in that the elastomeric nipple (5) is designed in the form of a ridge-like flexible extension which projects distally beyond the probe head (3).

9. Arrangement according to claim 8, characterized in that the elastomeric nipple (5) has a rounded distal end and a length extending distally beyond the probe head of up to 3 cm.

10. Arrangement according to one of claims 2 to 7, characterized in that the pressure sensor (9) is connected to a signaling means (11) arranged proximally on the ultrasonic probe (1), which is capable of generating an optical, acoustic and / or haptically perceptible signal.

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