Catheter having a healing dummy
09656018 ยท 2017-05-23
Assignee
Inventors
Cpc classification
A61B5/14532
HUMAN NECESSITIES
A61M25/0017
HUMAN NECESSITIES
A61M2025/0018
HUMAN NECESSITIES
A61M2039/025
HUMAN NECESSITIES
A61M1/85
HUMAN NECESSITIES
A61B5/14507
HUMAN NECESSITIES
International classification
A61M1/00
HUMAN NECESSITIES
A61B5/145
HUMAN NECESSITIES
Abstract
A catheter for implantation into tissue, the catheter comprising a tubing having a lumen and defining an outer boundary between the catheter and the tissue when the catheter is implanted in the tissue, a healing dummy being insertable in the lumen with clearance so as to prevent tissue ingrowth from the tissue into the lumen when the healing dummy is within the lumen, wherein the healing dummy is removable from the lumen by pulling the healing dummy relative to the tubing out of the lumen, and a perfusion insert being insertable in the lumen when the healing dummy is removed from the lumen, being configured for supplying a perfusion fluid to the tissue so as to initiate interaction between the perfusion fluid and tissue, and being configured for collecting perfusion fluid after interaction with tissue.
Claims
1. A catheter for implantation into tissue, the catheter comprising: a tubing having a lumen and defining at least partially an outer boundary between the catheter and the tissue when the catheter is implanted in the tissue; a healing dummy being insertable in the lumen with clearance so as to prevent tissue ingrowth from the tissue into the lumen when the healing dummy is within the lumen, wherein the healing dummy is removable from the lumen by pulling the healing dummy relative to the tubing out of the lumen; and a perfusion insert being insertable in the lumen when the healing dummy is removed from the lumen, being configured for supplying a perfusion fluid to the tissue so as to initiate interaction between the perfusion fluid and the tissue, and being configured for collecting perfusion fluid after interaction with the tissue; wherein the healing dummy and the tubing are in flush, or the healing dummy protrudes along an insertion direction over the tubing by a distance in a range between 0 and 0.5 mm, wherein the perfusion insert comprises a hollow cylindrical tube delimiting an inner lumen and delimiting together with the tubing an annular lumen, wherein the inner lumen is configured for supplying the perfusion fluid to the tissue and the annular lumen is configured for collecting the perfusion fluid.
2. The catheter of claim 1, wherein the perfusion insert and the tubing are in flush, or the perfusion insert protrudes along an insertion direction over the tubing by a distance in a range between 0 and 0.5 mm.
3. The catheter of claim 1 wherein the healing dummy comprises a venting unit configured for venting a region between the healing dummy and the tissue upon pulling the healing dummy relative to the tubing out of the lumen.
4. The catheter of claim 1, wherein the healing dummy has an edgeless surface facing tissue when being inserted in the tubing.
5. The catheter of claim 1, wherein the healing dummy is configured to completely fill the opening in the tubing so that no recess remains in the tubing when the healing dummy is inserted into the tubing.
6. The catheter of claim 1, wherein the perfusion insert is configured to fill the opening in the tubing apart from one or more fluid channels.
7. The catheter of claim 1, wherein a surface roughness of the tubing and/or of the healing dummy is in a range between 1 nm and 100 nm.
8. The catheter of claim 1, wherein the clearance between the healing dummy and the tubing is formed by a spacing between an inner surface of the tubing and an outer surface of the healing dummy, the spacing being in a range between 0.01 mm and 0.5 mm.
9. The catheter of claim 1, wherein a surface of the healing dummy is functionalized.
10. The catheter of claim 1, wherein the healing dummy is made of a fluoropolymer.
11. The catheter of claim 1, wherein the perfusion insert comprises a multi-lumen structure delimiting in its interior multiple lumen, wherein one or more of the multiple lumen is/are configured for supplying the perfusion fluid to the tissue and one or more of the multiple lumen is/are configured for collecting the perfusion fluid.
12. The catheter of claim 1, wherein the tubing has a wall thickness in a range between 0.01 mm and 0.3 mm.
13. The catheter of claim 1, wherein the tubing is made of a material which has a Shore hardness in a range between D30 and D90.
14. A medical system, comprising: a catheter including: a tubing having a lumen and defining at least partially an outer boundary between the catheter and a tissue when the catheter is implanted in the tissue; a healing dummy being insertable in the lumen with clearance so as to prevent tissue ingrowth from the tissue into the lumen when the healing dummy is within the lumen, wherein the healing dummy is removable from the lumen by pulling the healing dummy relative to the tubing out of the lumen; and a perfusion insert being insertable in the lumen when the healing dummy is removed from the lumen, being configured for supplying a perfusion fluid to the tissue so as to initiate interaction between the perfusion fluid and the tissue, and being configured for collecting perfusion fluid after interaction with the tissue; wherein the healing dummy protrudes along an insertion direction over the tubing by a distance in a range between 0 and 0.5 mm, the catheter configured to be inserted into the tissue; and a pump being in fluid communication with the catheter for conducting the perfusion fluid towards the catheter and for conducting a sample fluid resulting from an interaction of the perfusion fluid with the tissue away from the catheter, wherein the perfusion insert comprises a hollow cylindrical tube delimiting an inner lumen and delimiting together with the tubing an annular lumen, wherein the inner lumen is configured for supplying the perfusion fluid to the tissue and the annular lumen is configured for collecting the perfusion fluid.
15. The medical system of claim 14, wherein the catheter is a cerebral catheter for implantation into a brain, wherein the medical system comprises a blood-brain barrier integrity detector configured for detecting, after having substituted the healing dummy by the perfusion insert, whether the blood-brain barrier has recovered after an injury by an implantation of the healing dummy.
16. The medical system of claim 14, wherein the blood-brain barrier integrity detector is configured for detecting whether a blood-brain barrier has recovered by detecting whether a marker substance supplied to blood of a physiological subject by a marker supply unit is detectable in the perfusion fluid.
17. The medical system of claim 14, further comprising a perfusion fluid, wherein the perfusion fluid comprises a mixture of NaCl, MgCl, CaCl.sub.2, KCl, NaH.sub.2PO.sub.4, Na.sub.2HPO.sub.4, or glucose.
18. The medical system of claim 14, further comprising a perfusion fluid, wherein the perfusion fluid comprises a mixture of 13010 mmol/l Na, 4.30.5 mmol/1 K, 0.720.10 mmol/l Ca, 0.400.08 mmol/l Mg, 13510 mmol/l Cl, and 31 mmol/l glucose.
19. A method of implanting a catheter into tissue, the method comprising: implanting the catheter into the tissue so that a tubing having a lumen defines at least partially an outer boundary between the catheter and the tissue; inserting a healing dummy in the lumen with clearance so as to prevent tissue ingrowth from the tissue into the lumen when the healing dummy is within the lumen and maintaining the healing dummy in the lumen for a predefined healing time; after expiry of the healing time, removing the healing dummy from the lumen by pulling the healing dummy relative to the tubing out of the lumen; after the removing, inserting a perfusion insert in the lumen for supplying a perfusion fluid to the tissue so as to initiate interaction between the perfusion fluid and the tissue; and collecting perfusion fluid after the interaction with the tissue; wherein the healing dummy and the tubing are in flush, or the healing dummy protrudes along an insertion direction over the tubing by a distance in a range between 0 and 0.5 mm, wherein the perfusion insert comprises a hollow cylindrical tube delimiting an inner lumen and delimiting together with the tubing an annular lumen, wherein the inner lumen is configured for supplying the perfusion fluid to the tissue and the annular lumen is configured for collecting the perfusion fluid.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The invention will be described in more detail hereinafter with reference to examples of embodiment but to which the invention is not limited.
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DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
(11) The illustration in the drawing is schematically. In different drawings, similar or identical elements are provided with the same reference signs.
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(13) As can be taken from
(14) As can be taken from
(15) During the implantation procedure of
(16) Hence, as can be taken from
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(18) The perfusion insert 502 is inserted in the lumen 400 after having removed the healing dummy 302 from the lumen 400, i.e. as a substitution therefore. The perfusion insert 502 is configured, i.e. has a corresponding supply interface 540, for supplying a perfusion fluid from a perfusion fluid container 504 to the brain so as to initiate an interaction between the perfusion fluid and brain tissue. The perfusion insert 502 is further configured, i.e. has a corresponding drain interface 550, so that perfusion fluid can be collected after the interaction with the brain tissue (hence, a sample fluid having contributions of the initial perfusion fluid and of the brain tissue, particularly brain fluid thereof). In the embodiment of
(19) The medical system 500 furthermore comprises a pump 506 which is in fluid communication with the catheter 300 and conducts the perfusion fluid from the perfusion fluid container 504 to the inner lumen 400 within the perfusion insert 502. The perfusion fluid then mixes with brain fluid or other kind of brain tissue, and after this interaction, the corresponding sample fluid is pumped back via an annular space 508 via the pump 506 away from the catheter 300.
(20) A control unit 510 (such as a microprocessor or a central processing unit) controls operation of the various components of the medical system 500. Particularly, the pump 506 is controlled by the control unit 510. Furthermore, the control unit 510 controls a valve 512 which can be opened or closed so as to pump the perfusion fluid with a predetermined flow rate towards the catheter 300. The control unit 510 furthermore controls a valve 514 which connects the sample fluid with a sensor 516. The sensor 516 is supplyable with the sample fluid by the pump 506 and senses a value of a physiological parameter such as the glucose level by analyzing the sample fluid. Hence, an online sensing method is implemented in the medical system 500. Also the sensor 516 is controlled by the control unit 510 and may report the result of the sensing to the control unit 510. Alternative sensing is possible, for instance brain pressure measurement.
(21) Optionally, it is possible to verify with medical system 500 whether the blood-brain barrier is in fact again intact after the healing procedure, as will be described in the following in more detail. A marker substance (for instance evans blue and sodium fluorscein) may be supplied to the blood of the patient (not shown). The marker substance is selected so that it cannot pass an intact blood-brain barrier. If the blood-brain barrier is still disturbed by the implantation injury, the marker may pass the blood-brain barrier and may be sucked by the pump 506 via a valve 522 controllable by the control unit 510 towards a marker detection unit 524. The marker detection unit 524 determines whether the marker can be detected and provides a corresponding result to the control unit 510. If the marker is identified in the brain tissue by the marker detection unit 524, it is possible to reinsert the healing dummy 302 into the lumen 400 so as to continue the healing procedure without the danger of tissue ingrowth. If however no markers are detected by the marker detection unit 524, the supply of a perfusate fluid as described above can be initiated.
(22) As one of many alternatives to the embodiment of
(23) The above description refers to the supply of a perfusion fluid towards the lumen 400 and the detection of a corresponding sample fluid, for instance for continuous monitoring of the glucose level or any other physiological parameters. However, additionally or alternatively, it is also possible to supply a medication to the brain. For this purpose, a medication container 526 can be provided in which a corresponding medication is stored. Under control of the control unit 510, a valve 528 can be opened so as to supply medication from the medication container 526 to the lumen 400. Alternatively, it is also possible that a medication is within the perfusion fluid stored in container 504.
(24) It may be advantageous to ensure, for instance by a corresponding operation of the pump 506, that the flow rate of the supplied fluid is equal to the volume of the fluid recovered from the annulus 508 so as to prevent the formation of oedemas and other undesired physiological conditions in the brain.
(25) During the implantation, the healing dummy 302 is located in an interior of the outer flexible tubing 304 of the catheter 300. The healing dummy 302 remains within the flexible tubing 304 until the implantation trauma is healed. The healing dummy 302 effectively prevents growth of tissue into an interior of the flexible tubing 304. Before carrying out the actual measurement or monitoring of the physiological parameter, the healing dummy 302 is removed and the inner tubing 502 is inserted into the outer tubing 304 forming a larger annular volume (see reference numeral 508) as compared to the scenario in which the healing dummy 302 is inserted into the flexible tubing 304. The dimensions and the position of the inner tubing 502 and the healing dummy 302 are configured so that no new additional irritation of the tissue occurs. Also a pressureless removal of the healing dummy 302 by means of a ventilation unit (not shown) may reduce the risk of new additional irritation of the tissue. During the actual measurement, the perfusion fluid is conducted as a measurement fluid through the inner tube 502 into the tissue. With the same pump speed fluid is withdrawn via the annulus 508 between the outer tubing 304 and the inner tubing 502 so that the liquid volume remaining in the tissue is zero or very close to zero. After the measurement, it is possible to again substitute the inner tubing 502 by the healing dummy 302. The measurement can be repeated as often as desired without a new damage of the tissue.
(26) In
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(28) After having removed the healing dummy 302 from catheter 600, it is possible to insert one of the perfusion inserts shown in the embodiments of
(29) The embodiment of
(30) In the alternative embodiment of
(31) The embodiment of
(32) Alternatively, the embodiment of
(33) For an online sensing system, all surfaces of the catheters shown in
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(35) D>d.
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(40) The embodiment of
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(42) Thus, the catheter 1500 is configured so that, when the healing dummy 302 is inserted in the lumen of tubing 304 to prevent tissue ingrowth, the healing dummy 302 and the tubing 304 are in flush (i.e. the healing dummy 302 is inserted in the tubing 304 without protruding over the tubing 304), so that the healing dummy 302 and the tubing 304 together form the flat and planar structure at the common front face 1502. This flushing between front face of healing dummy 302 and front face of tubing 304 is highly advantageous because this fully avoids anew injury of tissue after primary implantation of the catheter 1500. Moreover, also the perfusion insert 502 and the tubing 304 are also in flush and are configured so that, when the perfusion insert 502 is inserted in the lumen of tubing 304, the front surface of the perfusion insert 502 and the front surface of the tubing 304 are aligned to one another. By providing both the healing dummy 302 and the tubing 304 as well as the perfusion insert 502 and the tubing 304 to flush thereby forming an aligned front face being free or basically free of a protrusion, an anew injury of the tissue due to the maneuvering of healing dummy 302 or perfusion insert 502 may be safely avoided after the initial implantation of the catheter 1500.
(43) The aligned or flushing position (as well as the slight protruding position in other embodiments such as in
(44) It should be noted that the term comprising does not exclude other elements or steps and the a or an does not exclude a plurality. Also elements described in association with different embodiments may be combined.
(45) It should also be noted that reference signs in the claims shall not be construed as limiting the scope of the claims.
(46) Implementation of the invention is not limited to the preferred embodiments shown in the figures and described above. Instead, a multiplicity of variants are possible which use the solutions shown and the principle according to the invention even in the case of fundamentally different embodiments.