The present invention relates to the technical field of medical instruments and, more specifically, to a force sensor and an electrophysiology catheter.
In recent years, catheter systems have been developed for interventional treatment of, for example, cardiac arrhythmias and refractory hypertension. For example, in the treatment of atrial fibrillation, one type of cardiac arrhythmia, an ablation or mapping catheter may be introduced into the heart via a vein or artery to find an aberrant electrical signal position or pathway by endocardial mapping, and then apply energy at the position or pathway to ablate it to eliminate or alter undesirable electrical signals, thus achieving curative results. Another example is the treatment of refractory hypertension through renal artery ablation, in which an ablation catheter may be arterially introduced into an artery connecting the abdominal aorta and the kidney to ablate and block the parasympathetic nerve pathway to lower the blood pressure.
For ablation therapy, how strongly an electrode disposed on a distal end of the used catheter contacts the target vessel wall or tissue is considered very important. Weak contact will lead to a superficial ablation lesion, and is thus incapable of allowing effective blockage of the aberrant electrical signals or nerve conduction. However, excessively strong contact may probably lead to perforation of the tissue, i.e., an increased safety risk. In order to avoid these issues, existing catheters of this type with force sensors at the distal end can effectively sense the contact strength between the electrode and the vessel wall or tissue. For instance, magnetic position sensors may be equipped in such a catheter to sense contact strength between the distal end thereof and the target organ. However, such sensors suffer from certain limitations in practice, such as tending to give distorted results due to interference from external magnetic fields and limiting other catheter functionalities such as three-dimensional magnetic positioning due to the use of magnetic fields. There are also catheter systems using force-sensitive materials as force sensors for sensing loads on the distal end. Although such systems are good at axial load measurement, they are lack of accuracy in non-axial load measurement. There are still other catheters employing fiber-optic systems for sensing contact forces with the vessel wall or organ, but they are difficult to package and make and expensive and require external electrical signal devices.
The electrophysiology catheter includes a distal end at which the force sensor 10 is disposed. The force sensor 10 is configured to obtain the magnitude and direction of a contact force that occurs when the distal end of the catheter is brought into contact with the surface of a vessel wall or tissue. In other words, the force sensor 10 is configured to measure a reaction force in response to the contact force exerted by the catheter's distal end on the vessel wall or tissue.
In practice, in order to guide such electrophysiology catheters to various target sites, distinct guide sheaths 20 are designed with distal ends having different curved shapes. Additionally, such a guide sheath 20 should be constructed to be relatively stiff in order to maintain the designed curved shape while ensuring that a respective electrophysiology catheter can reach the target site. Consequently, as the electrophysiology catheter is guided through the guide sheath 20, the force sensor 10 tends to experience a great deformation under the action of significant forces exerted by the guide sheath 20.
This requires the force sensor 10 to be able to withstand large bending loads. Otherwise, when impacted by a large force, the force sensor 10 may break, leading to failure or a shortened service life of a strain gauge therein due to a load exceeding its measuring range.
As shown in
Each transverse groove 11 is an arc-shaped groove cut along a circumference of the wall of the elastic tube 1 and provided at its both opposing ends each with a longitudinal groove 12 for mitigating stress concentration at the opposing ends of the transverse groove 11 and thus increasing its tensile strength.
However, as shown in
It is an objective of the present invention is to provide a force sensor and an electrophysiology catheter. The force sensor can be effectively avoided from experiencing any significant impact when the electrophysiology catheter is guided through a sheath. In this way, it is maintained within a predetermined deformation range that prevents breakage of an elastic tube of the sensor and enables an extended service life of any strain gauge therein.
To achieve the above objective, the present invention provides a force sensor, comprising an elastic tube and a strain gauge arranged on the elastic tube, wherein:
the force sensor further comprises a pierced transverse groove formed in the elastic tube, the transverse groove having a first wall and a second wall;
the force sensor further comprises at least one first limiting structure disposed between two opposing ends of the transverse groove, each of the at least first limiting structure comprising a first limiting portion and a second limiting portion, the first limiting portion being connected to the first wall, the second limiting portion being connected to the second wall; and
when the transverse groove deforms axially, the first limiting portion and the second limiting portion are able to responsively move relative to each other until being engaged with each other.
To achieve the above objective, the present invention further provides an electrophysiology catheter, comprising a distal end and an above force sensor disposed at the distal end.
Preferably, the first limiting portion is a female portion with a first internal surface and the second limiting portion is a male portion with a second external surface, the first internal surface and the second external surface being arranged opposite to each other and defining a clearance between the first internal surface and the second external surface, and wherein the second limiting portion is confined within the first limiting portion.
Preferably, the force sensor comprises a plurality of the first limiting structures spaced apart from one another across a same circumferential surface.
Preferably, the male portion and female portion match each other in shape.
Preferably, the force sensor further comprises at least one second limiting structure disposed between the opposing ends of the transverse groove, each of the at least one second limiting structure comprising a third limiting portion connected to the first wall and a fourth limiting portion connected to the second wall, and
when the transverse groove deforms axially, the third limiting portion and fourth limiting portion are able to responsively move relative to each other until being engaged with each other.
Preferably, the third limiting portion is a male portion with a third external surface and the fourth limiting portion is a female portion with a fourth external surface, the third external surface and the forth external surface being arranged opposite to each other and defining a clearance between the third external surface and the forth external surface, and wherein the third limiting portion is confined within the fourth limiting portion.
Preferably, the first limiting portion, second limiting portion, third limiting portion and fourth limiting portion are of a same shape.
Preferably, the force sensor comprises a plurality of the first limiting structures, and wherein each of the at least one second limiting structure is disposed between adjacent two of the first limiting structures, the third limiting portion is a portion between adjacent two of the first limiting portions thereof and the fourth limiting portion is a gap between adjacent two of the second limiting portions.
Preferably, an external surface of the second limiting portion and an external surface of the third limiting portion are arranged axially opposite to each other and define a clearance between the external surface of the second limiting portion and the external surface of the third limiting portion.
Preferably, the second limiting portion comprises a second vertical portion and a second horizontal portion, and the third limiting portion comprises a third vertical portion and a third horizontal portion, the second vertical portion being connected to the second wall, the third vertical portion being connected to the first wall, the second and third horizontal portions together forming an engagement.
Preferably, the male portions are trapezoidal, L-shaped or T-shaped.
Preferably, the force sensor further comprises two longitudinal grooves arranged at the respective opposing ends of the transverse groove.
Preferably, the transverse groove extends in a curved shape on a circumferential surface of the elastic tube.
Preferably, the transverse groove is formed in the elastic tube by laser cutting.
Preferably, the force sensor comprises a plurality of the transverse grooves and a plurality of the strain gauges, the transverse grooves spaced apart from one another across the elastic tube in an axial direction of the elastic tube and staggered from one another along a circumferential direction of the elastic tube, each of the strain gauges disposed between two opposing ends of a respective one of the transverse grooves.
According to the present invention, the force sensor includes an elastic tube and a strain gauge arranged on the elastic tube. A pierced transverse groove is formed in the elastic tube, and at least one first limiting structure is disposed between two opposing ends of the transverse groove. Each first limiting structure includes a first limiting portion connected to a wall of the transverse groove and a second limiting portion connected to the other wall of the transverse groove. In the event of an axial deformation occurring to the transverse groove, the first and second limiting portions will simultaneously move relative to each other. In particular, when the axial deformation reaches a certain level, the two limiting portions will engage with each other. As a result, the transverse groove is maintained within a predetermined deformation range that can avoid breakage of the elastic tube and result in a prolonged service life of the strain gauge.
In these figures,
10 denotes a force sensor; 1, an elastic tube; 11, a transverse groove; 111, a first wall; 112, a second wall; 12, a longitudinal groove; 13, a first limiting portion; 14, a second limiting portion; 15, a third limiting portion; 16, a fourth limiting portion; and 20, a guide sheath.
Specific embodiments of the proposed force sensor and electrophysiology catheter will be described in greater detail with reference to the accompanying drawings so that the present invention will become more apparent and readily understood. The present invention is not limited to the following specific examples, and general alternatives well known to those skilled in the art are also embraced within the scope thereof.
Additionally, while the present invention is described in detail with reference to the annexed schematic figures, these figures are presented only for the purpose of facilitating the detailed description of the examples rather than limiting the invention in any sense.
As used herein, the terms “proximal” and “distal” describe relative orientations, positions and directions between elements or actions, viewed by a physician operating the product. Without wishing to be limiting, a “proximal end” usually refers to an end of the product close to the physician during normal operation, while a “distal end” usually refers to an end thereof that enters the patient first. “Axial” and “longitudinal” refer to an axial direction of an elastic tube, while “circumferential” and “transverse” refer to a circumferential direction thereof.
As used in the specification, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. As used in the specification, the term “or” is generally employed in the sense including “and/or” unless the context clearly dictates otherwise.
According to the present invention, in order to enhance breakage resistance of the elastic tube, each transverse groove 11 is maintained within a predetermined deformation range that ensures that the elastic tube 1 will not break. To this end, at least one first limiting structure is added between opposing ends of each transverse groove 11.
In response to an axial deformation of the transverse groove 11, a relative movement will occur in the at least one first limiting structure, and when reaching a limit position, an engagement will occur, defining a maximum deformation amount of the transverse groove 11. In this way, any significant impact can be effectively avoided when the electrophysiology catheter is guided through a sheath, and the elastic tube 1 can be maintained within a predetermined deformation range that prevents breakage of the elastic tube and enables an extended service life of a strain gauge. Generally, such a strain gauge provides a strain measurement range of ±20,000 microstrains. Accordingly, the at least one first limiting structure is generally configured to limit the maximum deformation amount to be not over 20,000 microstrains.
According to the present invention, each first limiting structure may include a first limiting portion and a second limiting portion. The first limiting portion is connected to a first wall of the transverse groove 11. Upon any axial deformation of the first wall, the first limiting portion will experience a synchronous axial displacement. Additionally, the second limiting portion is connected to a second wall of the transverse groove 11. Similarly, when the second wall deforms axially, a synchronous axial displacement will responsively occur to the second limiting portion. The first wall opposes the second wall along a widthwise direction of the transverse groove 11.
Thus, when the elastic tube 1 is stressed and stretched by a force, both the first and second walls will deform accordingly, driving the first and second limiting portions to move relative to (i.e., toward or away from) each other. When the axial load is below a predefined threshold (e.g., 500 g), the relative movement of the first and second limiting portions will be accommodated in a preset clearance without resulting in a contact therebetween. However, when the axial load exceeds the predefined threshold, the first and second limiting portions will move toward or away from each other until the limit position is reached, where they cooperate to form a snap-fit engagement that prevents any of them from further moving. At this point, the transverse groove 11 deforms by a maximum allowable amount under the action of the snap-fit engagement of the first and second limiting portions.
Obviously, in order to control the maximum deformation amount of the transverse groove 11, an axial clearance between the first and second limiting portions is necessary for allowing an axial relative movement between the two limiting portions while ensuring a space for compressive or tensile deformation of the elastic tube 1. Therefore, the maximum deformation amount can be controlled, in general terms, below 20,000 microstrains by suitably setting a dimension of the clearance.
Various examples of the limiting structure according to embodiments of the present invention will be described in greater detail below with reference to
As shown in
As shown in
As shown in
Those skilled in the art will appreciate that the present invention is not limited to the above-listed three implementations of the first and second limiting portions, as these portions may also assume any other suitable shape or structure, such as a shape like the letter “T”, a shape like a petal, or a structure having one or more sides, as long as the second limiting portion can be confined within the first limiting portion and not dislodge therefrom without structural damage.
The present invention further provides a fifth embodiment, The fifth embodiment is similar to the first embodiment except that, between adjacent two first limiting structures, a second limiting structure is arranged, which includes a third limiting portion 15 connected to the first wall 111 of the transverse groove 11 and a fourth limiting portion 16 connected to the second wall 112 of the transverse groove 11. For the sake of brevity, similarities between the two embodiments will not be described herein. In response to an axial deformation of the transverse groove 11, the third and fourth limiting portions 15, 16 can move relative to each other until they are engaged with each other.
As shown in
More specifically, as shown in
Experimental results demonstrate that, a conventional transverse groove 11 without any limiting structure arranged between its opposing ends can withstand a maximum bending load of 463 g and the elastic tube 1 will break upon any increase in the load, as indicated by the curve s2 in
In any of the above embodiments, the transverse groove 11 may extend in a curved shape on the circumferential surface of the elastic tube 1. That is, the transverse groove 11 appears curved in a front view of the elastic tube 1, and arc-shaped in a top view of the elastic tube 1. Preferably, the transverse groove is formed in the elastic tube 1 by a laser cutting. The force sensor 10 further includes strain gauge(s) arranged on the outer wall of the elastic tube 1. The number of the strain gauge(s) corresponds to the number of the transverse groove(s). Each strain gauge may be provided on either a pierced or non-pierced section of the elastic tube 1. Here, the term “pierced section” refers to a portion encompassing one of the transverse groove(s) (i.e., the strain gauge can cover the transverse groove 11), whereas the term “non-pierced section” refers to a portion of the elastic tube 1 that is not pierced. Preferably, each strain gauge is arranged on a non-pierced section of the elastic tube 1. More preferably, a plurality of the transverse grooves 11 are axially spaced apart from one another across the elastic tube 1 and staggered from one another along the circumferential direction thereof, with each strain gauge preferably disposed between opposing ends of the respective transverse groove.
At last, while a few preferred embodiments of the present invention have been described above, the present invention is not limited to the scope of these disclosed embodiments. For example, in case of a plurality of limiting structures being provided, all of them may have the same structure, or one or more of them may have a different structure.
According to embodiments of the present invention, the force sensor includes an elastic tube and a strain gauge arranged on the elastic tube. A transverse groove is formed in the elastic tube, and at least one first limiting structure is disposed between opposing ends of the transverse groove. Each first limiting structure includes a first limiting portion connected to a wall of the transverse groove and a second limiting portion connected to the other wall of the transverse groove. In the event of an axial deformation occurring to the transverse groove, the first and second limiting portions will responsively move relative to each other. In particular, when the axial deformation reaches a certain level, the two limiting portions will engage with each other. As a result, the transverse groove is maintained within a predetermined deformation range that can avoid breakage of the elastic tube and result in a prolonged service life of the strain gauge. In particular, adding one or more such limiting structures will not lead to increased structural complexity or impaired overall appearance of the elastic tube, and the limiting structures themselves are very easy to form and suitable for industrial production and use.
The description presented above is merely that of a few preferred embodiments of the present invention and does not limit the scope thereof in any sense. Any and all changes and modifications made by those of ordinary skill in the art based on the above teachings fall within the scope as defined in the appended claims.
Number | Date | Country | Kind |
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201810142142.X | Feb 2018 | CN | national |
Filing Document | Filing Date | Country | Kind |
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PCT/CN2019/074760 | 2/11/2019 | WO | 00 |