WO2013057204A1

WO2013057204A1 - Disposable insertion tip, endoscopy system and cooling system

Info

Publication number: WO2013057204A1
Application number: PCT/EP2012/070680
Authority: WO
Inventors: Fritz Pauker; Marc Henzler; Andreas KÜGLE
Original assignee: Digital Endoscopy Gmbh
Priority date: 2011-10-20
Filing date: 2012-10-18
Publication date: 2013-04-25
Also published as: DE102011084918B3

Abstract

Disclosed is a disposable insertion tip (1) having an insertion tip unit (12) which can be connected to a minimally invasive medical or an endoscopic instrument (2) and a tip (11) at the distal end of the insertion tip unit (12). The disposable insertion tip (1) is made from a solidified medium that becomes liquid at body temperature.

Description

EI NWEGEIN LEAD TIP, DOS COPY SYSTEM AND COOLING SYSTEM

description

The present invention relates to a disposable introducer tip, an endoscope copying system having at least one such disposable introducer tip, and a refrigeration system for manufacturing such a disposable introducer tip.

State of the art

In modern minimally invasive surgery, very small

Cuts and thereby allows very minor surgical trauma. The very small incisions reduce wound pain and cause minor scars on the area of intervention. This, in turn, is perceived as cosmetically advantageous, moreover, due to the faster healing of the intervention area, a shorter hospital stay results.

This is possible because the operation is performed by only one hole-like opening created by a so-called trocar to gain access to a body cavity (eg, the abdominal cavity). The trocar itself is in its simplest form a tube (tube) with an inner diameter of z. B. 0.5-12 mm, in which a guided in the tube pin sits with a tip. The tip cuts through the tissue and penetrates into the body cavity together with the tube. The stylus is withdrawn leaving the tube in place and serving as a guide for an optical instrument (endoscope), gripping instrument, cutting instrument or other surgical instrument.

Trocars are made of plastic, titanium or so-called surgical steel. Trocars are designed as a one-time or multiple-use instrument. Depending on the shape of the tip, a distinction is made between a sharp and a blunt trocar. In the following description, the phrase "proximal end / proximal side" is used to refer to the end / side facing the attending physician. "Distal end / distal side" is used to close the end / side which points away from the attending physician - ie towards the patient.

WO 92/10141 Al discloses an insertion tip according to the preamble of claim 1.

Also US 5 957 947 A discloses an insertion tip according to the preamble of claim 1.

Object of the invention

It is the object of the present invention to provide an improved insertion tip suitable for a one-way application.

In addition, the present invention is intended to provide an improved endoscopy system with a disposable insertion tip.

With regard to the Einwegeinführspitze the above-described object is achieved by a Einwegeinführspitze with the features of claim 1.

An endoscopy system is defined in claim 12. A cooling system for manufacturing a one-way insertion tip is defined in claim 13. Advantageous developments of the invention are the subject of the dependent claims.

In accordance with the present invention, the disposable introducer tip includes an introducer tip body to which a minimally invasive medical or endoscopic instrument is connectable and a tip disposed at the distal end of the introducer tip body. The disposable insertion tip is formed of a solidified medium that becomes fluid at body temperature. Such Einwegeinführspitze can be produced inexpensively. In addition, their handling is very simple, since it can only be plugged or connected to an instrument and inserted by means of the instrument in the body. The body heat at the piercing site increases the temperature of the Einwegeinführspitze up to a height at which you change the state of aggregation of Einwegeinführspitze from solid to liquid and melts the Einwegeinführspitze, so is liquid. After melting the disposable insertion tip, the instrument is already at the handling or surgical site. Removal of the insertion tip is thus eliminated.

The solidified medium can be transparent. The surgeon is thus a very precise handling in the determination of the puncture allows. Unlike previous materials that were not transparent, the surgeon can see through the tip when inserting the disposable insertion tip.

The medium can be water ice. Then the Einwegeinführspitze is particularly easy and inexpensive to produce.

The medium can be isotonic ice. A good compatibility in the body is guaranteed. After melting the disposable introducer tip, the isotonic fluid can be absorbed by the body. A suction can be omitted.

The tip may have a conical shape. Such a one-way insertion tip is well suited for punctuation.

The tip may have a shape of an elongate cutting surface, or the insertion tip body may have a cylinder taper at its distal end such that the distal portion of the cylinder taper forms the tip. Such a one-way insertion tip can be applied similarly to a cutting trocar. The insertion tip body may be cylindrical or polygonal. This results in a high versatility in the application.

The introducer tip body can be cylindrical and have a thread to which a medical minimally invasive or an endoscopic instrument can be screwed. The thread can z. B. be an internal thread into which a medical minimally invasive or an endoscopic instrument can be screwed. Such Einwegeinführspitze sits very safe on the instrument. Slipping out of the instrument is even after partially begun

Melting process still prevented.

The introducer tip body may have a sterilization insert. As a result, a particularly safe hygienic application is possible.

The solidified medium can be colored. As a result, different sizes (diameter) or different shapes (circular, oval, rectangular, triangular, octagonal cross-section, etc.) of Einwegeinführspitzen be marked by respective colorations.

The medium may be incorporated with a gel to increase the tensile strength. As a result, the breaking strength of the insertion tip is increased.

The above-explained aspects of the present invention can be suitably combined.

Brief description of the drawings

Fig. 1 shows a perspective view of a disposable insertion tip according to the invention, in which an instrument is inserted.

FIG. 2 shows the one-way insertion tip of FIG. 1 with the instrument on a reduced scale. 3 shows a cooling system for producing a one-way insertion tip according to the invention.

Hereinafter, the present invention will be described in detail with reference to the drawings by way of embodiments.

Embodiment 1

First, with reference to Figs. 1 and 2, a first embodiment of the present invention will be described.

The disposable insertion tip of the present embodiment of the present invention is formed as a cylindrical insertion tip body 12 having a tapered tip 11. The cylindrical insertion tip body 12 and the conical tip 11 integrally form the one-way insertion tip 1.

The material of Einwegeinführspitze 1 is water ice in the present embodiment.

More specifically, the disposable introducer tip 1, suitable for minimally invasive surgery, consists of conditioned water which has been solidified by means of a corresponding molding so that the disposable insertion tip 1 of FIG. 1 results. There are several possibilities for producing such a one-way insertion tip 1 possible, to which reference is made below.

In the present exemplary embodiment, the insertion tip body 12 is cylindrically designed such that a medical minimally invasive instrument (gripping instrument, cutting instrument or another surgical instrument) 2 or an endoscopic instrument (camera, illumination instrument) 2, as shown in FIG. 1 can be inserted into the insertion tip body 12. In this case, the instrument 2 is inserted into the insertion tip body 12 so far that the distal end of the instrument 2 abuts the proximal end of the tip 11. The insertion tip body 12 has a wall thickness which gives it sufficient strength and stability. The inner shape of the insertion tip body 12 is thus adapted to the outer shape of a distal end portion of an instrument 2. Such an instrument 2 is shown for example in FIG. 2 shown.

In the case of application, the medical minimally invasive instrument 2 or the endoscopic instrument 2 with the one-way insertion tip attached at its distal end is inserted at a point at which the epidermis and / or the dermis has already been opened by means of a scalpel. Then, by means of the disposable insertion tip 1, the subcutis (subcutaneous tissue) is opened by piercing and the instrument 2 can be introduced with the disposable insertion tip 1 into the cavity under the skin. Due to the body temperature, the disposable insertion tip 1 melts relatively quickly after piercing.

Advantages of the present embodiment

Since the Einwegeinführspitze is made of sometimes suitably treated water, it is very inexpensive. The tip 11 of the Einwegeinführspitze 1 is transparent and thus allows the surgeon extremely precise handling in the determination of the puncture point. In contrast to previous materials that were not transparent, the surgeon can look through the tip when inserting the disposable insertion tip 1.

Second embodiment

In the above-described embodiment 1, the one-way insertion tip 1 consists of frozen, ie solidified, water. In the present second embodiment, the medium of Einwegeinführspitze 1 is made of isotonic ice. That is, an appropriate amount of saline (sodium chloride) is added to the water to give an isotonic saline solution. For example, the medium may consist of an isotonic saline solution of 0.9% sodium chloride. The medium of the disposable insertion tip 1 has an osmolarity similar to that of the blood plasma. Therefore, this medium is particularly well suited for a surgical procedure. The isotonic saline solution is absorbable by the body after melting the disposable insertion tip 1. In addition, isotonic saline is very inexpensive. In the solidified state isotonic saline solution is also transparent, so that the corresponding advantages of the first embodiment with regard to the handling in the second embodiment arise.

Third embodiment

In the first embodiment, the shape of the tip 11 has a conical shape. However, the present invention is not limited thereto. In the present third embodiment, which is not shown in the drawings, an elongated cutting surface is formed at the distal end portion of the tip of the one-way insertion tip. The elongated cutting surface may extend perpendicular to the axial direction of the insertion tip body 12 as in a flat-head screwdriver. In one variation, the elongate cutting surface may extend at an angle to the axial direction of the insertion tip body 12 tapering toward the distal end point as in a knife or scalpel.

In a modification of the third embodiment, which is also not shown in the drawings, the cylindrical insertion tip body is merely chamfered at its distal end. A suitable helix angle is, for example, between 20 and 75 degrees. It should be noted that the present invention is not limited to these bevel angles, but any suitable bevel angle may be selected at which cutting or piercing of the insertion tip can be favorably carried out.

Fourth embodiment

Hereinafter, a fourth embodiment of the present invention is described, which is also not shown in the drawings. The cylindrical one Insertion tip body 12 is provided in the present embodiment with an internal thread. An instrument 2 having an external thread corresponding to the internal thread of the insertion tip body 12 may be screwed into the insertion tip body.

The one-way insertion tip of the present embodiment is seated on the instrument 2 very securely. Slipping out of the instrument 2 is still prevented even after partially started melting.

Other alternatives

In the present embodiments, the insertion tip body 12 is cylindrically structured. However, alternatives are also conceivable in which the insertion tip body has a polygonal or oval cross section and is thus suitable for instruments which have a corresponding polygonal or oval cross section. The corresponding instrument is then inserted into the polygonal or oval insertion tip body, resulting in a particularly advantageous security against rotation.

Other tip shapes of Einweginführspitze invention are possible, such. A pyramidal shape, a triangular shape, a triangular shape with a hollow cut, a shape of a so-called half-moon cut, a blunt rounded shape, a tapered cylinder with a small opening at the distal end, etc. In principle, the tip and the insertion tip body can have any shape, the can be produced by means of the solidified medium.

In the present exemplary embodiments, water or isotonic ice is discussed as the medium for the one-way introduction tip. The present invention is not limited thereto. Any medium which is suitable for minimally invasive surgical treatment and thus suitable for the body to be treated and which can melt immediately or shortly after piercing / incising is applicable as the material for the one-way insertion tip. In principle, the medium of the one-way insertion tip 1 can be any medium as long as it melts at body temperature and is not harmful to the body. The medium for the disposable introducer tip may be inked by compatible means to identify, for example, different sizes (diameter) or different shapes (circular, oval, rectangular, triangular, octagonal cross-section, etc.) of the disposable introducer tips by respective stains. As a result, when a variety of disposable insertion tips are included in a cool box, a desired one-way insertion tip can be quickly found.

The medium may be incorporated with a gel to increase the tensile strength. As a result, the breaking strength of the insertion tip is increased. Other admixtures that increase the breaking strength of Einführspitze are conceivable. The gel and the other admixtures as well as the salt displace the solidification point of the insertion tip. The solidification point of the insertion tip should, however, be chosen so that just before piercing the insertion tip into the body, the insertion point is sufficiently solidified or firm enough that a piercing into the body with sufficient strength and stability is possible, and after piercing by the body heat the transition to the liquid state takes place.

In the fourth embodiment, the insertion tip body 12 is provided with an internal thread and the instrument 2 has an external thread. In an alternative, the introducer tip body and the instrument may instead be connected to a bayonet catch. Other forms of interlocking between the insertion tip and the instrument are also possible.

Production of the one-way insertion tip

A cooling system for manufacturing the one-way insertion tip is described with reference to FIG. 3 described. The one-way insertion tip 1 can be produced in a suitable manner by means of a shaped body 31 in a cooling system 3. The molded body 31 is provided with a port not shown for supplying the medium melting at body temperature. The cooling system 3 according to FIG. 3 has a housing 33 in which the molded body 31 is centrally accommodated. The molded body 31 is usually a divided molded body, and can consist of an upper mold body part and a lower mold body part, each having the (negative) shape of the Einwegeinführspitze to be generated in half-mold as a groove, as is conventional in a classical (casting) form method. Other moldings are conceivable. In composite molded body parts results in a cavity in the form of a cylinder with a tip, this cavity of the outer shape of the Einwegeinführspitze 1 to be generated - such. B. the in Fig. 1 Einweginführspitze shown 1 - corresponds. In this cavity, an instrument 2 is introduced concentrically, wherein the instrument 2 can be deposited on a holder 32 so that the distal end of the instrument 2 is concentric with the cylindrical shape of the composite molded body parts. As a result, a uniform wall thickness of the insertion tip body 12 is achieved.

In the cooling system according to FIG. 3, the instrument 2 may be an instrument used with the disposable insertion tip 1 attached during minimally invasive surgery. That is, the instrument 2 is already provided with the disposable insertion tip 1 in use. In this case, the instrument 2 may be a medical minimally invasive instrument or an endoscopic instrument, wherein the endoscopic instrument may again be an illumination instrument or an image acquisition instrument.

In an alternative, the instrument 2 employed in the cooling system of FIG. 3 may be a separate standard component which is removed from the disposable insertion tip 1 after the cooling operation is completed and the disposable insertion tip 1 has solidified and received its intended shape. The Einwegeinführspitze 1 can then be stored separately from the surgical instrument (cooled) and placed shortly before the moment of application to the appropriate instrument (or screwed).

Provision of the one-way insertion tip

The disposable insertion tip according to the invention can be kept in stock in a larger number in a corresponding cooling box. For example, such a cooler Einwegeinführspitzen various common diameter and sizes included. Alternatively, a cool box may contain a certain number of the same one-way insertion tip to avoid confusion between different disposable insertion tips.

The introducer tips can be held ready with a sterilization insert. As a result, the application of Einwegeinführspitze invention is very hygienic.

LIST OF REFERENCE NUMBERS

1 disposable insertion tip

2 instrument (medical minimally invasive instrument, endoscopic instrument)

3 cooling system

11 tip

12 insertion tip body

31 molded body (upper mold body part, lower mold body part)

32 holding device

33 housing

Claims

claims

1. Einwegeinführspitze (1) with

an insertion tip body (12) to which a medical minimally invasive or an endoscopic instrument (2) can be connected, and

a tip (11) disposed at the distal end of the insertion tip body (12),

characterized in that

the disposable insertion tip (1) is formed of a solidified medium that becomes fluid at body temperature.

2. Einwegeinführspitze according to claim 1, wherein

the frozen medium is transparent.

3. Einwegeinführspitze according to claim 1 or 2, wherein

the medium is water ice.

4. Einweginführspitze according to one of claims 1-3, wherein

the medium is isotonic ice.

5. disposable insertion tip according to one of claims 1-4, wherein

the tip (11) has a conical shape.

6. disposable insertion tip according to one of claims 1-4, wherein

the tip has a shape of an elongate cutting surface or the insertion tip body (12) has a cylinder taper at its distal end such that the distal portion of the cylinder taper forms the tip.

7. Einwegeinführspitze according to one of claims 1-6, wherein

the insertion tip body (12) is cylindrical or polygonal

8. disposable insertion tip according to one of claims 1-6, wherein the introducer tip body (12) is cylindrical and has a thread to which a medical minimally invasive or an endoscopic instrument (2) can be screwed.

9. Einwegeinführspitze according to one of claims 1-8, wherein

the introducer tip body (12) has a sterilization insert.

10. Einwegeinführspitze according to one of claims 1-9, wherein

the solidified medium is colored.

11. Einweginführspitze according to one of claims 1-10, wherein

the medium, a gel is added to increase the tensile strength.

12. Endoscopy system with

at least one disposable insertion tip (1) according to one of claims 1 -

11

and

at least one medical minimally invasive instrument (2) and / or at least one endoscopic instrument (2).

13. A cooling system for producing a Einwegeinführspitze according to one of claims 1-11, with

a housing (33),

a molded body (31) capable of forming the one-way insertion tip (1),

a connection for supplying the shaped body (31) with the melting at body temperature medium for forming the Einwegeinführspitze (1) and

a cooling device for cooling the introduced in the molded body (31) medium to solidification temperature.