KR100319980B1 - Apparatus and method for fixing the sensor in the human lumen - Google Patents

Abstract

The present invention relates to an apparatus for fixing a sensor to which a sensor support implanted into a lumen in a human body is connected, and a method for fixing the same. For example, the fixation device becomes rigid in the lumen of the human body by dilatation or suture of the lumen in the human body. The fixture is also a stent or a dedicated anchoring ring with a sensor support connected to the fixture. Fixtures are inserted during the intervention or during special implantation. The sensor can be periodically or continuously signaled from the outside to the lumen in the human body. In addition, the sensor has a protective coating to protect the sensor from damage during implantation.

Description

Apparatus and method for fixing the sensor in the lumen of the human body

The present invention generally relates to an apparatus and a method for securing a sensor and protecting the sensor during implantation in a lumen in the human body.

Sensors for monitoring and / or recording various physical, chemical and physiological changes in humans are sunk medical devices, such as pacemakers, which can be permanently implanted at specific locations in the human body, as described in US Pat. No. 4,485,813. Known for. This sensor is used to monitor certain physical and / or physiological parameters of the implanted material. This sensor can be maintained in the material even during extended periods of time to continuously monitor information about the material.

The sensors described in US Pat. No. 4,485,813 strictly limit the number of possible positions to be implanted due to the difficulty of fixing them independently of the need to position the sensor in a medical device such as a pacemaker. Restrictions on the position and fixation of the sensor indicate that the sensor for application in the lumen is not useful.

The sensors used to monitor parameters in the lumen consist of a thin film which is very sensitive to mechanical pressure. As a result there is a great risk that the sensor will be damaged during implantation or positioning. Damage to the sensor lowers the sensor's performance or eliminates the possibility of surgery. For example, the membrane of the sensor is destroyed during implantation, making the sensor inoperable. Because of the risks involved in the process of implanting the sensor, there are significant costs and risks of damage or destruction during the implantation of the sensor. Thus, there is also a need for an apparatus and method for protecting a sensor while implanting and securing the sensor.

Accordingly, the present invention provides an apparatus and method for fixing a sensor in the lumen of the human body. Using these devices and methods, sensors that receive signals from far away can be fixed in the lumen of the human body. Such sensors can be used to monitor and / or record physiological parameters such as the pressure and velocity of the fluid flow contained in the lumen and biochemical parameters such as the level of gas streams and biochemical components.

Monitoring the condition of the lumen recently refers to a slight degree of intervention, and the recovery of this monitoring is limited by the relative risk of the required intervention. Accordingly, the present invention provides a sensor device that can be implanted temporarily and permanently into the lumen at any time without any interaction or physical intrusion, and can receive signals from an external location, such as a body surface.

1 a shows a first fixing device of a sensor according to a preferred embodiment of the invention.

FIG. 1B illustrates a method for securing the sensor of FIG. 1A in a lumen in accordance with a preferred embodiment of the present invention.

2A and 2B show a second fixation of the sensor before and after expansion, respectively, according to a preferred embodiment of the present invention.

3A and 3B show a third fixture of the sensor before and after expansion, respectively, in accordance with a preferred embodiment of the present invention.

4 illustrates a second method for securing the sensor in the lumen using a third fixation device of the sensor of FIGS. 3A and 3B in accordance with a preferred embodiment of the present invention.

5 shows a mask for etching the flat design of the third fixture of the sensor of FIGS. 3A and 3B in accordance with a preferred embodiment of the present invention.

6 shows a mask for etching the flat design of the second fixture of the sensor of FIGS. 2A and 2B in accordance with a preferred embodiment of the present invention.

7 shows a fourth fixture of a sensor before expansion in accordance with a preferred embodiment of the present invention.

8 illustrates a mask for etching the flat design of the fourth fixture of the sensor of FIG. 7 in accordance with a preferred embodiment of the present invention.

9A and 9B show an enlarged side view of the cross section of the sensor support from FIG. 3A along a line formed between two different points a 'and a' of the present invention.

The present invention provides an apparatus and method for securing such sensors in particular desired positions and / or preferred positions in the lumen of the human body. Fixation of these sensors can be accomplished by surgical intervention as required or by independent catheterization. In addition, the sensor may be associated with repair devices such as bypass stitches, aneurysmal repair devices, stents, or may be installed as a dedicated fixture for the sensor. have.

The sensor is immobilized inside the lumen by a number of methods, including attaching the sensor directly in place, including a hole around the end of the sensor, and attaching to the suture of the bypass during surgery using surgical adhesive. Can be. The sensor may be positioned within the lumen using a carrier or support (of any shape or size) connected to or adjacent to the repair device as part of a repair device such as a stent or correction divice of the aneurysm. Moreover, the sensor can be positioned in the lumen using a dedicated device such as an anchoring ring and held in place and secured in place by expansion by a catheter balloon. . The anchoring ring does not necessarily have a circular shape, but instead may have an oval or other shape that is most suitable for positioning. In addition, the anchoring ring may have a separate carrier or support to support the sensor. The carrier or support may have any size and shape, such as round, rectangular, diamond-shaped and straight, with or without curved ends or curved ends, and may also be prepared as a border or solid material.

The carriers can also be attached to the composite sensors, for example, the two connections of the bypass section, the two sensors where the carrier is located in each of the stents, in order to monitor for possible leaks around the sleeve. There are two sensors attached to the carrier and the sensors attached to the inlet of the aneurysm and the outside of the canal. In addition, the sensor may have a complex recovery device or a dedicated device that is supported between two anchoring rings and supports in the lumen the sensor with or without a carrier.

The sensor may be connected to or supported by the carrier by making a depression such as a groove or notch in the sensor so that the carrier portion can be inserted therein. The sensor part can be configured with an extension or protrusion like a lip to make the carrier larger. Furthermore, the carrier can be attached to the sensor by welding, gluing or a combination of electrical methods.

During an intervention such as an aneurysm implant, percutaneous transluminal coronary (PTCA), or cardiac transplantation, the sensor is fixed in the lumen and then periodically monitored to evaluate its effectiveness or to detect various parameters. Can be monitored. For example, sensors may be monitored periodically to diagnose deterioration of the corrective effect or the progression of long-term course and symptoms associated with the disease.

Multiple sensors can be implanted and monitored individually or simultaneously to obtain a degree of variability along the lumen and across a recovery device or section. These sensors can be fixed at various locations in the lumen, such as both wounds treated with PTCA, with or without stents, both sides of the bypass section, and in front of, behind, and around the aneurysm repair device.

The invention also provides an apparatus and method for protecting the sensor during implantation. To protect the sensor during implantation and to eliminate the risk of damage and destruction of the sensor during implantation or positioning, the sensors are coated with a protective layer that dissolves in an aqueous solution, which is removed immediately or after the sensor is placed in the human body. . The materials used for the thickness and strength of the coating vary depending on the location of the sensor, the type of sensor, the degree of protection and the desired dissolution rate.

The fasteners are made of thin stainless steel sheet metal or other materials such as flat plates of metal, nonmetallic or bioabsorbable materials in a first preferred pattern. The flat pattern can be produced by any suitable technique, such as etching the design into a thin sheet of metal, squeezing with a sharp laser, or the like.

Once cut, the metal material is deformed to etch a satisfactory design. Roll flat metal until the edges join to make a breakdown from the flat metal pattern. The portion supporting the sensor located along the periphery of the fixture is located at right angles to the cross section of the ring formed by the fixture, or otherwise located from the ring formed by the fixture. The locations where the edges meet are joined together by some welding. The fixture is then physically and electrochemically cleaned.

1A and 1B mentioned illustrate the fixing device of the sensor and the first method for fixing the sensor in the lumen according to a preferred embodiment of the present invention, respectively.

1A shows a sensor (No. 1) having two holes (No. 3) at the distal end of the sensor for attachment to sutures in the lumen. In FIG. 1B, the cardiac artery (No. 5) is shown starting at the aorta (No. 7) and occluding (No. 9). Bypass (11) is connected between the part of the aorta (No. 13) and the part (No. 15) past the block (No. 9). The sensor (No. 1) is located near the adjacent Ossium (No. 17) or Bypass (No. 19). Instead, the sensor (No. 1) can be located at the terminal Ossium (No. 21), at the end (No. 23) in front of the terminal Ossium, or at the end (No. 25) after the end Ossium. When using multiple sensors it can be a combination of these positions or any other desired location. The sensor (No. 1) is fixed in place using two holes (No. 3) to attach to the suture. Instead, the sensor 1 can be fixed in place using surgical adhesive or surgical thread.

2A and 2B, a second fixation of the sensor before and after expansion, respectively, is shown in accordance with a preferred embodiment of the present invention.

2a shows an unexpanded stent 30 with a first sensor support 32 and a second sensor support 34. Instead, the stent 30 includes one or more sensor supports. For example, the third sensor support would be located opposite the first sensor support (No. 32). In FIG. 2B, the stent 30 of FIG. 2A is expanded. Expansion may be by balloon catheterization or other processes. To secure the sensor in the lumen, stent 30 is placed when the sensor is normal during the medical procedure using the stent. Before or after implanting the stent (No. 30) into the lumen prior to dilation, the sensor is placed or attached to or in place of the first sensor support (32) or the second sensor support (34). The stent 30 is then expanded or implanted into the lumen and then expanded. The above process is used to fix various sensors in the lumen by adding a process of placing or attaching each sensor in or on the corresponding sensor support.

3A and 3B, a third fixture of the sensor before and after expansion, respectively, is shown in accordance with a preferred embodiment of the present invention.

FIG. 3A shows the fixing device 40 in the form of an anchoring ring 42 in an unexpanded state connected to the sensor support 44. Fixture 40 is formed of a stretchable material that does not automatically return to its original shape after expansion. The anchoring ring (42) consists of a number of elliptical faces (no. 46) that are connected to each other in the middle of an elongated oval to form a ring. The sensor support 44 is connected to one of the elliptical surfaces 46 and only a small portion (49) and is perpendicular to the cross section of the anchoring ring 42 having a circular surface. The sensor support 44 has a diamond shape, but any desired shape is possible. Furthermore, complex sensor supports attached to the anchoring ring (42) are possible. Instead, the anchoring ring (42) can be composed of one sinusoidal ring with a sensor support attached to one or more peaks because it does not support the lumen.

In FIG. 3B, the fixing device 40 is shown in an expanded state. In order to fix the sensor in the lumen, the fixation device 40 is positioned in the lumen, for example, during expansion and by balloon catheterization or other procedures. Before or after implanting the fixation device (No. 40) into the lumen prior to dilation, the sensor is placed or attached to or in the sensor support (No. 42). The fixture (40) is then expanded or implanted into the lumen and then expanded. The above process is used to fix various sensors in the lumen by adding a process of placing or attaching each sensor in or on the corresponding sensor support.

Referring to FIG. 4, there is shown a second method for securing the sensor in the lumen using a third fixation device of the sensor of FIGS. 3A and 3B in accordance with a preferred embodiment of the present invention. As shown in FIG. 1B, the coronary artery (No. 5), starting from the aorta (No. 7) and having a block (No. 9), passes the part of the aorta (No. 13) and past the block (No. 9). There is a bypass (No. 11) connected between them. The sensor (50) supported by the sensor support (44) connected to the anchoring ring (42) of Figs. 3A and 3B is connected to the closest part of the adjacent bypass (19) or the terminal ostium (No. 21). It may be located at the end (number 23) in front of the terminal ossium or at the end (number 25) after the terminal ossium. When several sensors are used, they can be located by a combination of these positions where anchoring rings can be used, and in some other desired location. Sensor 50 is fixed in place by expansion by balloon catheter insertion.

5, a mask is shown for etching a flat design of the fixture of the sensor of FIGS. 3A and 3B in accordance with a preferred embodiment of the present invention. Mask 52 is made for etching the planar design of the fixture. The flat design is then etched onto thin sheet metal or other stretchable material. The flat design is then cut from the metal of the sheet with a sharp laser. Then clean the cut flat design and bend it into a circle or another shape. Points 54 and 56 represent the positions of the planar design connected by welding after bending the planar design. We make anchoring ring by welding. The anchoring ring 58 is located almost in the center of the mask 52, but other positions also function. In addition, multiple sensor supports can be located on either side of the fixture design.

Referring to FIG. 6, a mask for etching the planar design of the fixture of the sensor of FIGS. 2A and 2B in accordance with a preferred embodiment of the present invention is shown. Mask 60 is made for etching the planar design of the stent. The flat design is then engraved on thin sheet metal or other stretchable material. The flat design is then cut from the metal of the sheet with a sharp laser. The cut flat design is then cleaned and bent in a circle or other shape, bent and connected by welding. The sensor support 62 is located almost in the center of the mask 60, but other positions function as well. In addition, multiple sensor supports can be located on either side of the fixture design.

Referring to FIG. 7, there is shown a fourth fixing device of a sensor before expansion in accordance with a preferred embodiment of the present invention. The fixing device in the form of a double anchoring ring (No. 70) consists of the first ring (No. 72) and the second ring (No. 74), between the two unexpanded rings (No. 72 and 74). Has a sensor support (No. 76). Fixture 70 is formed of a stretchable material that does not automatically return to its original shape after expansion. The sensor support (76) is connected to each part (78) of the anchoring rings (72 and 74) perpendicular to the cross section of the rings (72 and 74) forming the circular plate, and two rings (72). Located between and 74). The sensor support 44 has a diamond shape, but any desired shape is possible. In addition, multiple sensor supports attached to the fixture 70 are also possible. Instead, the fixture 70 may not consist of a sinusoidal ring with a sensor support attached to one or more peaks because it does not support the lumen. Fixing device 70 may be composed of two stents on both sides of the sensor support, or may have a complex sensor support attached to the fixing device.

Referring to FIG. 8, there is shown a mask for carving out the flat shape of the fixture of the sensor of FIG. 7 in accordance with a preferred embodiment of the present invention. Mask 80 is made to etch the planar design of the fixture. The flat design is then engraved on thin sheet metal or other stretchable material. The flat design is then cut from the metal of the sheet with a sharp laser. Then clean the cut flat design and bend it into a circle or other shape. Points 82 and 83, 84 and 85 represent the positions of the planar design connected by welding after bending the planar design. We make anchoring ring by welding. The sensor 87 is located almost in the center of the mask 80, but other positions function as well. In addition, multiple sensor supports can be located on either side of the fixture design.

9A and 9B, an enlarged side view of the cross section of the sensor support from Fig. 3A along a line formed between two different points a 'and a' of the present invention.

In Fig. 9A, groove 90 is formed in two parts at the end of sensor 92 by cutting with an iron saw, etching, laser cutting, etc., and then providing a support of sensor 92. The sensor 92 is inserted into the sensor support 44 to position the two parts of the sensor support 44 at No. 90. Instead of grooves, two notches can be made at the distal end of sensor 92 where two parts of the sensor support 44 can be located.

FIG. 9B shows a sensor 94 having a lip around the upper portion 98 of the sensor. Instead, sensor 94 may have one or more protrusions along the edge of upper portion 98 of the sensor. Instead, the ribs or protrusions may be located at the bottom or other parts of the sensor. The sensor 94 is connected to the sensor support 44 by a method such as adhesive, welding or soldering, and the lip 96 or the protrusion is connected to the edge 99 of the sensor support. Instead, sensor 94 is placed on sensor support 44 and is supported by a lip 96 or a protrusion.

The sensor has a thin film that is very sensitive to mechanical pressure due to the sensitivity of the sensor used to monitor and is coated to protect it from damage or destruction during sensor placement. The coating is made of a protective layer that is soluble in aqueous solution and must melt as soon as the sensor is placed. The material used for the thickness and strength of the coating depends on various factors including the location of the sensor, the type and physiological relevance of the sensor, the parameters measured and the desired placement rate.

The first example of a coating material is a cured sugar syrup composition made from nearly equal amounts of glucose and sucrose. The ratio of glucose to sucrose varies but depends on the application.

A second example of a coating material is a mixture of hydroxy propyl methyl cellulose, hydroxy propyl cellulose and colloidal silicone dioxide, all finely ground and mixed in water It is used as a coating pill and commonly available as Opadry-Oy-34817 (Coloron Ltd., Italy).

Other materials may also be used as coatings to protect the sensor. The protective coating is made of another material that is hard and thick enough to protect the sensor from damage and destruction during implantation, which melts immediately after implantation and is harmless to the human body at the location where it is intended to be placed.

The sensor may be coated in a useful manner for coating materials such as spraying coating material onto the sensor, immersing in a liquid bath, pouring the coating material, or immersing and applying the coating material. In addition, the coating may only cover the film of the sensor, and may cover a wider or entire portion of the sensor.

Therefore, the effect of the present invention is to provide an apparatus and method for fixing a sensor in the lumen of the human body. Using these devices and methods, sensors that receive signals from far away can be fixed in the lumen of the human body. Such sensors can be used to monitor and / or record physiological parameters such as the pressure and velocity of the fluid flow contained in the lumen and biochemical parameters such as the level of gas streams and biochemical components. The present invention also provides a sensor device that can be temporarily and permanently implanted into the lumen at any time without any interaction or physical intrusion, and can receive signals from external locations such as the body surface.

Claims (32)

Fixture of sensor in lumen of human body consisting of fixture and sensor support connected to fixture The fastener of claim 1 wherein the fastener is a stent. 3. The fastener of claim 2 having a stent with a distal end and a sensor support connected to the distal end of the stent. 2. The holding device of claim 1 wherein the holding device is an aneurysm repair device. The fastener of claim 1 wherein the fastener is an anchoring ring. 6. A fastener according to claim 5 wherein the anchoring ring consists of at least one material forming a parameter and is positioned with at least one sinusoidal perpendicular to the cross section of the anchoring ring. 7. The fastener of claim 6 wherein the sensor support is connected to the peak of the sinusoid of the anchoring ring. 6. A fastener according to claim 5, wherein the anchoring ring consists of a plurality of oval faces having a long portion and a small portion, and the middle portion of the long portion is almost connected to each other. 9. A fastener according to claim 8 wherein the sensor supports are connected to each other substantially in the middle of the elliptical short portion of the anchoring ring. The fastener of claim 1 wherein the fastener comprises at least a first anchoring ring and a second anchoring ring and the sensor support is connected between the first anchoring ring and the second anchoring ring. The fastener of claim 1 wherein the fixture comprises at least a first stent and a second stent, and the sensor support is connected between the first stent and the second stent. The fastener of claim 1, wherein the sensor support consists of at least a first sensor and a second sensor spaced apart from each other in the lumen. 13. The device of claim 12, wherein the fixture has a first end and a second end, the first sensor support generally adjacent the first end, and the second sensor support generally adjacent the second end. Featured Fixture The fastener of claim 1 wherein the fastener is expandable. The fastener of claim 1 wherein the sensor has at least one notch-like settlement at the distal end of the sensor and at least one portion of the sensor support is located within at least one notch-like settlement. The fastener of claim 1 wherein the sensor has a groove-like settlement in at least a portion of the sensor and at least one portion of the sensor support is located within the groove-like settlement. 2. The fixation of claim 1 wherein the sensor has a lip-like extension at at least a portion of the sensor and at least a portion of the lip-like extension extends to the deepest portion of the sensor support. Instrument The fastener of claim 1 wherein the sensor has at least one protrusion at the distal end of the sensor, the at least one protrusion extending to the deepest portion of the sensor support. The sensor is supported by a sensor carrier and includes a fixing device for forming a perimeter capable of discriminating the width, the fixing device having a first end and a second end; Fixation mechanism of the sensor in the lumen of the human body, which is connected to the first end of the fixing device and consists of at least one sensor support which generally extends in equilibrium to the perimeter in a straight line direction from the second end. The sensor is supported by a sensor carrier and includes a fixing device for forming a perimeter capable of discriminating the width, the fixing device having a first end and a second end; In the fixture of the sensor in the lumen of the human body, which is connected to the first end of the fixture and extends generally equilibrium to the perimeter in a straight line direction from the second end, the sensor extends. Fixing mechanism of the sensor in the lumen of the human body, characterized in that consisting of a sensor having at least two holes The sensor is supported by a sensor carrier and includes a fixing device for forming a perimeter capable of discriminating the width, the fixing device having a first end and a second end; In the fixture of the sensor in the lumen of the human body, which is connected to the first end of the fixture and extends generally equilibrium to the perimeter in a straight line direction from the second end, the sensor extends. Fixing mechanism of the sensor in the lumen of the human body, characterized in that consisting of a sensor having a border (border) having at least two holes A fastener according to claim 21 wherein each hole is located in a different direction of the border. 22. The fastener of claim 21 wherein each of the holes is located at substantially the same distance from each other. Forming a mask; Etching the flat design of the fixture and sensor support on a portion of the material and the flat design of the fixture with the first and second ends; And a mechanism for securing the sensor to the lumen in the human body, comprising connecting the first end and the second end of the flat design of the fixture. The method of claim 24, wherein the securing device is a stent. The method of claim 24, wherein the material is a thin plate metal. 25. The method of claim 24, wherein the material is stainless steel. The method of claim 24, wherein the material is a bioabsorbable material. 25. The method of claim 24, wherein the connection of the first end and the second end of the flat design is by welding. Cut the flat design of the fixture and sensor support with a laser from a portion of the material, and flat design on the fixture with the first and second ends; How to make a mechanism for fixing the sensor to the lumen in the body consisting of connecting the first end and the second end of the flat design of the fixing device Protective layer for sensors implanted in the lumen in the human body, characterized in that it consists of glucose and sucrose and glucose and sucrose are nearly equal Implanted into the lumen of the human body characterized by consisting of finely divided hydroxy propyl methyl cellulose, hydroxy propyl cellulose, colloidal silicone dioxide and water Protective layer for the sensor