This application is the U.S. national phase under 35 U.S.C. ยง 371 of PCT International Patent Application No. PCT/EP2015/061049, filed on May 20, 2015, which claims the benefit of German Patent Application No. DE 10 2014 108 475.6, filed Jun. 17, 2014, the disclosures of which are hereby incorporated by reference herein in their entireties.
The present invention relates to an elongated guide sheath for delivering at least one medical instrument to a body lumen.
Minimally invasive procedures have been implemented in a variety of medical settings, e.g., for vascular interventions, such as angioplasty, stenting, embolic protection, electrical heart stimulation, heart mapping and visualization, and the like. These procedures generally rely on accurately navigating and placing instruments within a patient's vasculature. During such procedures, guide wires are used to advance catheters, sheaths or similar medical devices into a patient's body vessel.
Document U.S. Pat. No. 7,570,981 B2 discloses a complex guiding catheter system for accessing a patient's heart.
In order to stimulate the right atrium and the left ventricle of the human heart the Atrioventricular Septum (AV septum) of the heart can be used. Such a dual chamber stimulation is nowadays very common and corresponds to a greater extend to the physiological behaviour of the human heart than other stimulation methods. For such a stimulation usually an electrode is used which comprises an elongated helix construction at its distal end which needs to be exactly positioned at the AV septum.
It is possible to observe the movement of the electrode during implantation and to place the electrode exactly at the AV septum using an ultrasonic system for localization of the electrode tip. However, such an ultrasonic monitoring needs (beside the implantation of the electrode) another intervention which is usually started at the groin. However, this second intervention causes extra stress for the patient and requires another physician during the surgery. This is therefore an expensive, complicated method which does not conform to standard methods in this medical area.
The present invention is directed toward overcoming one or more of the above-mentioned problems.
Therefore, it is an object of the present invention to provide a system which is able to locate the AV septum easily and cost effectively.
At least the above problem is solved by an elongated guide sheath for delivering at least one medical instrument to a body lumen, wherein the sheath forms a preferably cylindrical and elongated first guiding sleeve and a preferably cylindrical and elongated second guiding sleeve at least partly separated by a shared wall section, wherein the longitudinal axis of the first guiding sleeve and the longitudinal axis of the second guiding sleeve run parallel to a longitudinal guide sheath axis, wherein the wall of the first guiding sleeve and/or of the second guiding sleeve comprises a slit which runs along at least part of the length of the respective guiding sleeve.
The inventive elongated guide sheath is of advantage because it is possible according to the present invention to first introduce a first catheter or a guide wire, preferably comprising a retaining element, and to temporarily fix the catheter or guide wire at the sinus coronarius for orientation, preferably using an inflated balloon. Then, the elongated guide sheath is inserted along the fixed first catheter or guide wire, wherein the first catheter or guide wire is accommodated within the first guiding sleeve. After that along the second guiding sleeve of the guide sheath a second catheter comprising the electrode for stimulation of the AV septum or a respective electrode is inserted and implanted at the AV septum using the catheter or guide wire fixed within the sinus coronarius as orientation. Thereby, an easy and cost effective implantation of an electrode at the AV septum is provided. No more additional ultrasonic monitoring is necessary. Accordingly, a second intervention for ultrasonic monitoring is avoided.
The inner diameter of the first guiding sleeve and/or the second guiding sleeve of the inventive guide sheath is preferably between 0.3 mm and 5 mm, more preferred between 0.5 mm and 3 mm. The wall thickness of the first guiding sleeve and the second guiding sleeve is preferably between 0.1 mm and 0.5 mm, more preferred between 0.2 mm and 0.3 mm.
The slit within the wall of the first guiding sleeve and/or of the second guiding sleeve is through going and allows accommodation of the first catheter and/or the second catheter and/or the guide wire within the guide sheath and/or easy removal. Further, the first guiding sleeve and the second guiding sleeve are accommodated beside each other.
In a preferred embodiment the slit in the wall of at least the first guiding sleeve and/or the second guiding sleeve extends over the entire length of the respective guiding sleeve which simplifies the step of clipping the sheath on the first catheter or guide wire and further eases removal of the guide sheath after implantation of the electrode.
It is further advantageous because of the same reason if the slit of the first guiding sleeve and/or the slit of the second guiding sleeve run at least sectionally parallel to the longitudinal guide sheath axis. In a further embodiment the slit of the second guiding sleeve is accommodated opposite to the slit of the first guiding sleeve in the respective outer wall.
In a preferred embodiment at its proximal end the guide sheath comprises a handle for rotation of the sheath around the longitudinal sheath axis or parallel thereto. This handle further facilitates implantation of the electrode at the AV septum.
A further embodiment of the inventive guide sheath comprises a tip at its distal end, preferably mainly formed by the shared wall section. This tip allows easier introduction of the longitudinal sheath into the vasculature. In a preferred embodiment, the walls of the first guiding sleeve and the second guiding sleeve are beveled at their distal end forming the tip.
It is further of advantage if the shared wall section separates the first guiding sleeve and the second guiding sleeve completely in order to reduce interaction between a guide wire or a to first catheter accommodated within the first guiding sleeve and a second catheter or electrode accommodated in the second guiding sleeve.
In order to monitor the position of the guide sheath the inventive guide sheath preferably comprises at its distal end, for example within or at the wall of the first guiding sleeve is and/or the second guiding sleeve, an X-ray visible element (marker) or magnetic element (marker). Preferably, the X-ray visible element has the form of a stripe. The X-ray visible element absorbs a larger amount of the impinging X-rays than the vicinity of this element within the human body during surgery and is therefore visible.
As indicated above in a preferred embodiment the first guiding sleeve is adapted to receive a first catheter and/or a guide wire, each preferably comprising a retaining element, for example an inflatable balloon or a clamp.
In a further preferred embodiment, the second guiding sleeve is adapted to receive a second catheter, preferably with an electrode, or an electrode.
At least the above problem is further solved with the same advantages by a system comprising an elongated guide sheath as described above, a first catheter and/or guide wire, each preferably comprising a retaining element, and a second catheter, preferably comprising an electrode, or an electrode.
Each of the above mentioned first and second catheters preferably comprises a catheter shaft and a connecting element for connection with the catheter control. The second catheter preferably accommodates at least one electrode with a respective connecting lead within its shaft. The first catheter preferably comprises a balloon at its distal end as the retaining element wherein the balloon may be inflated and deflated using a fluid supply accommodated within the catheter.
In order to remove the second catheter without removing or loosening the implanted electrode at the AV septum the system further preferably comprises a slitter.
A full and enabling disclosure of the present invention, including the best mode thereof, directed to one of ordinary skill in the art is set forth in the following specification of the preferred embodiments. Thereby, further features and advantages are presented that are part of the present invention independently of the features mentioned in the dependent is claims.
Further features, aspects, objects, advantages, and possible applications of the present invention will become apparent from a study of the exemplary embodiments and examples described below, in combination with the figures, and the appended claims.
The specification refers to the accompanying Figures showing schematically:
a the first catheter and the inventive guide sheath according to the embodiment of
In
The first embodiment of the inventive guide sheath 10 comprises an elongated body with a first cylindrical guiding sleeve 11 and a second cylindrical guiding sleeve 12. Each guiding sleeve 11, 12 has for example an inner diameter of about 1.83 mm and a wall thickness of about 0.24 mm. Hence, a 5 F (French) catheter may be accommodated by each sleeve 11, 12. The first guiding sleeve 11 and the second guiding sleeve 12 are accommodated in parallel beside each other such that the longitudinal sheath axis 14 runs parallel to the longitudinal axis (not shown) of the first guiding sleeve 11 and the longitudinal axis (not shown) of the second guiding sleeve 12. As best seen in
At the distal end of the inventive guide sheath 10 as best shown in
The guide sheath 10 further comprises at its proximal end a handle 21 that is fixed at the outer surface of the second guiding sleeve 12 for example (see
Now, the method for implantation of an electrode at the AV septum using the inventive guide sheath 10 and the inventive system of
In a first step the first catheter 30 shown in
In the second step, at the proximal end of the first catheter 30 which projects from the patient's body 5 (ref.
Then, a second catheter 40 containing an electrode 41 with its connecting lead or alternatively an electrode is inserted within the second guiding sleeve 12 of the inventive guide sheath 10 (see
Now, the guide sheath 10 is unclipped from the first catheter 30 and second catheter 40 by means of the first slit 18 and the second slit 19 and removed from the vasculature of the patient. Then, the first catheter 30 is removed after the temporary fixation of the first catheter within the sinus coronaries 51 is released, for example by deflation of the balloon 31. This step is shown in
Then, the shaft of the second catheter 40 is removed from the patient's body using a slitter 55 (see
As the skilled person derives from the above explanation the inventive guide sheath 10 allows an easy and cost effective as well as exact location and implantation of an electrode at the AV septum 53. An additional ultrasonic monitoring system is not necessary.
The first guiding sleeve 61 has an inner diameter d61 of about 2 mm and the second to guiding sleeve 62 an inner diameter d62 of about 3 mm. The wall thickness w60 of the guide sheath 60 is about 0.1 mm. The height h60 of the guide sheath 60 is about 15 F.
As it can be seen in the cross section depicted in
Analogous to the embodiment of
As depicted in
It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof.
Number | Date | Country | Kind |
---|---|---|---|
10 2014 108 475 | Jun 2014 | DE | national |
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/EP2015/061049 | 5/20/2015 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2015/193047 | 12/23/2015 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
4602645 | Barrington | Jul 1986 | A |
5441504 | Pohndorf | Aug 1995 | A |
6544270 | Zhang | Apr 2003 | B1 |
6928313 | Peterson | Aug 2005 | B2 |
7570981 | Peterson | Aug 2009 | B2 |
8142446 | Shan | Mar 2012 | B2 |
20040147826 | Peterson | Jul 2004 | A1 |
20060247750 | Seifert | Nov 2006 | A1 |
20080009770 | Weber | Jan 2008 | A1 |
20080015625 | Ventura et al. | Jan 2008 | A1 |
20080082136 | Gaudiani | Apr 2008 | A1 |
20090198252 | Seifert | Aug 2009 | A1 |
20110301684 | Fischell | Dec 2011 | A1 |
Number | Date | Country |
---|---|---|
10 2011 050 173 | Nov 2012 | DE |
1 806 160 | Nov 2007 | EP |
2005112798 | Dec 2005 | WO |
Entry |
---|
Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority, International Search Report and Written Opinion of the International Searching Authority for PCT/EP2015/061049, dated Aug. 12, 2015 (10 pages). |
Number | Date | Country | |
---|---|---|---|
20170100579 A1 | Apr 2017 | US |