Inside-Out access strategy using new trans-vascular catheter approach

Axel Boese; Dirk Foerstenberg; Tong Wu; Michael Friebe

doi:10.1515/cdbme-2016-0100

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Inside-Out access strategy using new trans-vascular catheter approach

Axel Boese , Dirk Foerstenberg , Tong Wu and Michael Friebe

Published/Copyright: September 30, 2016

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From the journal Current Directions in Biomedical Engineering Volume 2 Issue 1

Abstract

Image guided minimal invasive treatment can have large benefits for patient recovery and is lowering hospitalisation costs. But an access path, minimizing patient’s risk, is needed to reach the target structure inside of the body. Beside the use of natural orifices like oral, vaginal or anal cavities, a percutaneous puncture is common to enter the body. Also an interstitial path can be selected but if the pathological structure is situated in the deep, a long accesses path is required. Thereby the risk of additional damage and affecting organ functionality is increased. A possible option to come closer to the target structure with less organ damage is by using the vascular system. Entering the vessel from an uncritical point, the vasculature can be used as “highway” to the target structures. For the treatment of these nearby structures, the vessel has to be punctured and occluded afterwards by a save procedure. We propose an Inside-Out access strategy using a new trans-vascular catheter approach.

Keywords: biopsy; catheter; minimal invasive therapy; puncture; radiation; trans-vascular access; treatment; tumor

1 Introduction

Image guided minimal invasive therapy is popular technique for the treatment of various diseases. The management of tumours, vascular diseases, abscesses, or removal of parts or whole organs are common examples [1]. The main characteristic is the accesses just via small incisions without direct sight on the situs. Image guidance helps to navigate instruments and identify the target structure. Intra procedural imaging can be divided into indirect [X-Ray, Computed tomography (CT), Magnet resonant imaging (MRI), Ultrasound (US)] and direct imaging (optical or video endoscopy) [2]. Examples of image guided minimal invasive procedures are endoscopic or laparoscopic surgeries, needle guided interventions or catheter based procedures [3]. Depending on the interventional technique, flexible or rigid instruments are used. Thus an access path along a given anatomical structure (flexible endoscopes, catheters) or in a straight axis (rigid endoscopes, needles) is possible. The main advantage of these procedures is the reduction of tissue damage compared to an open surgery. But also in these interventions there is a risk of injuring sensitive anatomical structures. The choice of the right access path to minimize the risk of critical or functional damage is the key for a successful minimal invasive procedure. For endoscopic surgery e.g. the NOTES (Natural Orifice Transluminal Endoscopic Surgery) technique is an approach to reduce superficial scarfs and reduce trauma. The instruments are inserted and navigated trough natural structures and cavities (intestine, uro-genital tract, stomach) until they are close to the target structure. Through a defined perforation, the instruments are leaving the pathway structure to perform the surgery.

Based on this strategy we propose the vasculature as access path for minimal invasive treatments. With that many more areas could be reached or more closely reached and with a potential reduction of surgery trauma. For that a specially developed catheter (I-O Device) is placed in a vessel close to the target structure. For guidance X-ray or in selected cases Ultrasound as external imaging can be used. The catheter would need to allow a save puncture of the vessel wall with a tube, avoiding bleeding and enable a reliable occlusion of the puncture site after treatment. Through the tube different treatment options are possible. Applications like local radiotherapy of tumours e.g. with seeds, local chemotherapy, drainage of bleedings [4] or abscesses, biopsies or even an implantation of radiation targets or special wire clips for aneurysm treatment could be possible. Sensitive structures like brain tissue could be preserved with an optimized access path using a trans-vascular approach.

2 Methods

2.1 Design of a save workflow

Based on the analysis of endovascular procedures, a workflow for a trans-vascular access approach was designed [5]. Focus of this concept is, to create a safe procedure for the puncture and occlusion of the vessel.

The workflow is structured in four major steps: “Placement” of the I-O device, “Puncture” of the vessel wall, “Treatment” at the target structure and “Occlusion” of the puncture site. Based on that, the following main functions and specifications have to be realised in the design process of the new I-O catheter device:

Secure placement on the desired position
Defined puncture of vessel wall
Sealing of puncture site to avoid bleeding
Provide access to target structure
Secure occlusion of puncture site after treatment
Visibility in imaging (position and bearing) of all parts of the device during the procedure

2.2 General concept of the I-O device

2.2.1 Functional parts of I-O device

The I-O device consists of a catheter, made of two tubes connected side by side to each other. A balloon with three connection holes is mounted on the tip. A 3D shaped X-ray marker is used for visualisation of position and bearing in imaging [6]. The tubes are forming a double lumen, one for inflation of the balloon, the other for the puncture device. The tube for inflation goes straight to the balloon. A separate entry hole on the tip of the inflation lumen allows guidance by a guide wire (rapid exchange). The puncture lumen enters the balloon through the proximal connection hole. The tip is glued on a third hole on the side wall of the balloon. Thus the distal part of the puncture tube can be bended by inflation of the balloon (Figure 1).

After insertion of the puncture device, the penetration of the vessel wall can be performed (Figure 2). The puncture device is a thin hollow pipe with a flexible metal tip allowing access to the target structure. After penetration of the vessel wall, an actual treatment is possible through the puncture device.

Figure 1

General concept of the I-O catheter.

Figure 2

Principal procedure of the vessel puncture with the I-O catheter device.

2.2.2 Placement strategy

A standard access point for vascular treatment like the femoral artery can be used for entering the vasculature. The newly designed I-O catheter can be placed in combination with a guide wire at the desired puncture position. Through rotation, the puncture route is aligned to the target area. The rotation of the I-O device can be estimated by the 3D shaped marker in X-ray imaging. For stable fixation on the position, the balloon is inflated. Additionally the balloon ensures a sealing of the puncture hole in the vessel wall to avoid bleeding. The guide wire can stay threaded in the tip of the I-O catheter to assist the placement for the entire procedure time.

2.2.3 Puncture

A flexible micro pipe with the functionality of puncture component is inserted into the puncture tube lumen. With the help of the bended tip of the puncture lumen the micro pipe is deflected towards the vessel wall. Then the penetration can be performed and the pipe can be advanced to the target structure for treatment.

2.2.4 Occlusion

The final stage is the occlusion of the puncture site after treatment. The micro pipe is pulled back into the puncture lumen. The sealing of the puncture hole is done by shifting and rotating the balloon catheter until the puncture site is blocked by the balloon itself. Therefore the pressure in the balloon has to be decreased to reduce friction. Haemostasis can be achieved by pressing the balloon against the puncture site sufficiently long. The whole device is subsequently removed.

3 Results

3.1 Set up of a prototype

A first prototype was built to test the designed procedure and workflow (Figure 3). A 2,3F Codman^® PROWlER micro catheter (Johnson&Johnson, USA) was used as base component of the prototype. A second lumen with the same dimension was added next to the catheter. A manually manufactured balloon was attached onto the tubes. The micro catheter provides access to the balloon for inflation via a side hole. The second lumen is fixed on the side wall of the balloon. After inflation of the balloon the tip of this lumen is moving towards the vessel wall. The 3D shaped X-ray marker, made of platinum wires, is attached proximal to the balloon.

Figure 3

Prototype of the I-O catheter; (A) deflated, puncture lumen is flat, (B) inflated, puncture lumen is moved towards side, (C) puncture component is pushed through puncture lumen.

A modified TRUFILL DCS ORBIT^® pipe (0.012 × 175 cm) (Cordis, DePuy Synthes, USA) was chosen as the puncture component.

3.2 Testing of the prototype

The described prototype was tested using a phantom made of plastic tubes. The phantom provides a liquid filled puncture side covered with a thin foil simulating an abscess.

The I-O device was placed on the puncture side under image guidance of an X-Ray system (Artis zeego, Siemens Healthcare, Erlangen Germany). To verify the alignment of the puncture lumen with the prepared puncture site, the 3D shaped X-ray marker was used [7]. After alignment the balloon was inflated with saline and contras agent (Imeron 300, Bracco, Germany) to fixate the position and to seal the puncture site. During inflation, the puncture lumen was moving towards the vessel wall as expected.

The TRUFILL DCS ORBIT^® pipe was inserted and pushed forward until it was visible in the fluoroscopic image. The thin foil of the phantom was punctured. The puncture pipe was removed completely. For simulating the haemostasis, the balloon was deflated a little and shifted into proximal direction. Thus the puncture site was sealed by the balloon. Figure 5 shows the described test phantom.

Figure 4

X-ray images of the I-O Catheter; (A) I-O catheter is placed, I 3D shaped marker, II bended puncture lumen, III target structure, IV guide wire; (B) puncture component is placed (V).

Figure 5

I-O catheter inside the phantom for feasibility testing.

4 Discussion

The puncture of a blood vessel is a dangerous event when it occurs unexpected, especially in sensitive structures like the brain. A planed and intentional performed puncture with a device that is designed for this procedure could make new and innovative therapies possible that have a potential of reaching target sites that are otherwise only reachable through interstitial pathways and that have a rather long path through healthy tissue.

The described I-O device shows good performance for a manually manufactured prototype. The three-hole-balloon is not easy to produce however. But the technique, to use the balloon for changing the direction of a flexible lumen is promising. This method could be used for a treatment strategy on vessel branches as well.

The overall procedure could be tested in a phantom experiment. A defined rotation of the catheter was possible due to the double lumen design. The 3D shaped markers provide an estimation of the bearing. The puncture with the modified micro pipe was possible. Also the sealing process seems to be a feasible procedure. For testing of a real sealing procedure, further trials on living objects are necessary.

5 Conclusion

A new device for minimal invasive treatment by an inside out strategy was introduced. After conceptual design a first prototype was built up. This prototype could be tested under imaging in a liquid filled phantom. The device showed good performance but has to be optimized further. Especially tests on living models are necessary to demonstrate reliable occlusion of the puncture site and the feasibility of the associated therapies.

Author’s Statement

Research funding: Supported BMBF Germany in context with the INKA project (03IPT7100X). Conflict of interest: Authors state no conflict of interest. Material and Methods: Informed consent: Informed consent is not applicable. Ethical approval: The conducted research is not related to either human or animal use.

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Published Online: 2016-9-30

Published in Print: 2016-9-1

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Articles in the same Issue

https://doi.org/10.1515/cdbme-2016-0100

Keywords for this article

biopsy; catheter; minimal invasive therapy; puncture; radiation; trans-vascular access; treatment; tumor

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