This disclosure relates to catheters. In particular, this application relates to pediatric angiographic, hemodynamic, and multi-track catheters.
The conventional multi-track angiographic catheter is widely used in pediatric and adult interventional labs across the country. However, there are many downsides to this catheter.
First, conventional multi-track catheters can often cause vessel damage because of its non-tapered tip. The non-tapered tip can lead to serious vessel wall damage, particularly while attempting to cross a region that was recently intervened upon. A vessel wall has three layers: the intima, media, and adventitia. To achieve a successful angioplasty result, one must tear through at least the intima. It is important to note that this tearing is uncontrollable. That is, an interventionist cannot control where along the intima the vessel will tear. Current theory proposes that the intima will tear at its weakest point. In time, as the vessel heals, the expectation is that the vessel will heal at this larger luminal diameter. Therefore, when a physician assesses the damage during a follow-up angiography, a multi-track catheter must be advanced cautiously into position. The abrupt transition of the non-tapered tip of the catheter can result in further, unintended, tearing of a vessel wall.
Second, conventional multi-track catheters can often cause blood loss. The circular catheter shaft that is inserted over a circular guidewire will often lead to malfunction of the sheath's hemostatic valve and result in substantial blood loss during the procedure. This may have a severe detrimental effect in the pediatric population.
Finally, conventional multi-track catheters are difficult to track. Typically, multi-track catheters only have one centimeter at the catheter tip in contact with the guidewire. Such minimal contact with the guidewire often times leads to difficulty in catheter advancement to the desired location. To circumvent this issue, an additional guidewire and/or another catheter needs to be inserted into the patient, both of which increase the cost, may result in the need for a larger vascular entry sheath, and decrease the efficiency of the procedure.
In one embodiment, a pediatric catheter includes a shaft with a distal end and a proximal end, a length of the shaft defined between the distal end and the proximal end. The shaft also includes a first section positioned near the distal end, the first section being defined by an outer wall and including a first aperture extending therethrough and a second aperture extending therethrough. The first aperture and the second aperture are at least partially separated by a concave wall that is integrally formed with the outer wall, and at least a portion of the outer wall has a tapered surface. The shaft also includes a second section extending from the first section towards the proximal end. The second section is at least partially defined by a concave wall that is coextensive with the concave wall of the first section, the second section having a third aperture extending therethrough, the aperture being coextensive with the second aperture of the first section. The catheter also has a hub coupled to the proximal end and configured to receive a guidewire therethrough.
In another embodiment, a pediatric catheter includes a shaft with a distal end and a proximal end, a first length of the shaft defined between the distal end and the proximal end. The shaft also includes a first section positioned at the distal end and having an elongate tip. The first section has an outer wall and a first aperture extending therethrough, and at least a portion of the outer wall having a tapered surface. The shaft also includes a second section extending from the first section towards the proximal end. The second section has an arcuate wall and a concave wall integrally formed with the arcuate wall. The arcuate wall is coextensive with at least a portion of the outer wall of the first section, and a second aperture extends through the second section. At least a portion of the second aperture is offset from the first aperture. A hub us coupled to the proximal end and configured to receive a guidewire therethrough.
In a further embodiment, a pediatric catheter includes a shaft with a distal end and a proximal end, a length of the shaft defined between the distal end and the proximal end. The shaft also including a first section positioned near the distal end. The first section is defined by an outer wall and includes a first aperture extending therethrough and a second aperture extending therethrough. At least a portion of the outer wall has a tapered surface. The shaft also includes a second section extending from the first section to the proximal end, and the second section is defined by an outer wall that is coextensive with a portion of the outer wall of the first section. The second section has a third aperture that is coextensive with the second aperture of the first section. A plurality of holes extend through the outer wall of the first section and are configured to allow fluid to flow from the second aperture. The holes are positioned circumferentially about outer wall first section, and each of the holes is positioned at different distances from the distal end. A hub coupled to the proximal end and configured to receive a guidewire therethrough.
Other aspects of the invention will become apparent by consideration of the detailed description and accompanying drawings.
Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways.
One or more embodiments are described and illustrated in the following description and accompanying drawings. These embodiments are not limited to the specific details provided herein and may be modified in various ways. Furthermore, other embodiments may exist that are not described herein.
With respect to
As shown in
With respect to
With respect to
As shown in
The catheter 10 of
The catheters 10, 210, 410, 410′ shown and described in
The catheters 410, 410′ of
For reasons of completeness, various aspects of the invention are set out in the following numbered clauses:
Clause 1. A pediatric catheter comprising:
a shaft including a distal end and a proximal end, a length of the shaft defined between the distal end and the proximal end, the shaft further including:
a first section positioned near the distal end, the first section being defined by an outer wall and including a first aperture extending therethrough and a second aperture extending therethrough, the first aperture and the second aperture being at least partially separated by a concave wall that is integrally formed with the outer wall, at least a portion of the outer wall having a tapered surface; and
a second section extending from the first section towards the proximal end, the second section being at least partially defined by a concave wall that is coextensive with the concave wall of the first section, the second section having a third aperture extending therethrough, the aperture being coextensive with the second aperture of the first section;
a hub coupled to the proximal end and configured to receive a guidewire therethrough.
Clause 2. The catheter of claim 1, wherein the tapered surface defines an angle ranging from 15 degrees to 30 degrees relative to an axis that is defined through the first aperture.
Clause 3. The catheter of claim 1, wherein a length of the tapered surface ranges from 10 mm to 20 mm.
Clause 4. The catheter of claim 1, wherein the first section extends along about 5% to 20% of the length of the shaft.
Clause 5. The catheter of claim 1, further comprising a plurality of reinforcement elements coupled to the second section, an opening being defined between the concave wall and a surface of each of reinforcement element.
Clause 6. The catheter of claim 1, wherein the concave wall of the second section creates a recess that is aligned with the first aperture such that the first aperture and the recess are configured to receive the guidewire.
Clause 7. A pediatric catheter comprising:
a shaft including a distal end and a proximal end, a first length of the shaft defined between the distal end and the proximal end, the shaft further including:
a first section positioned at the distal end and having an elongate tip, the first section having an outer wall and a first aperture extending therethrough, at least a portion of the outer wall having a tapered surface;
a second section extending from the first section towards the proximal end, the second section having an arcuate wall and a concave wall integrally formed with the arcuate wall, the arcuate wall being coextensive with at least a portion of the outer wall of the first section, a second aperture extending through the second section, least a portion of the second aperture being offset from the first aperture;
a hub coupled to the proximal end and configured to receive a guidewire therethrough.
Clause 8. The catheter of claim 7, wherein the tapered surface defines an angle ranging from 15 degrees to 30 degrees relative to an axis that is defined through the first aperture.
Clause 9. The catheter of claim 7, wherein a length of the tapered surface ranges from 10 mm to 22 mm.
Clause 10. The catheter of claim 7, wherein the first section extends along about 5% to 22% of the length of the shaft.
Clause 11. The catheter of claim 7, further comprising a plurality of reinforcement elements coupled to the second section, an opening being defined between the concave wall and a surface of each of reinforcement element.
Clause 12. The catheter of claim 7, wherein the concave wall of the second section creates a recess that is aligned with the first aperture such that the first aperture and the recess are configured to receive the guidewire.
Clause 13. The catheter of claim 7, wherein the second aperture is substantially crescent-shaped.
Clause 14. A pediatric catheter comprising:
a shaft including a distal end and a proximal end, a length of the shaft defined between the distal end and the proximal end, the shaft further including:
a first section positioned near the distal end, the first section being defined by an outer wall and including a first aperture extending therethrough and a second aperture extending therethrough, at least a portion of the outer wall having a tapered surface; and
a second section extending from the first section to the proximal end, the second section being defined by an outer wall that is coextensive with a portion of the outer wall of the first section, the second section having a third aperture that is coextensive with the second aperture of the first section;
a plurality of holes extending through the outer wall of the first section and configured to allow fluid to flow from the second aperture, the holes being positioned circumferentially about outer wall first section, each of the holes being positioned at different distances from the distal end;
a hub coupled to the proximal end and configured to receive a guidewire therethrough.
Clause 15. The catheter of claim 14, wherein the holes are offset from one another in a clockwise direction and in a horizontal direction.
Clause 16. The catheter of claim 14, wherein the second aperture and the third aperture define a crescent-shaped lumen.
Clause 17. The catheter of claim 14, wherein the tapered surface defines an angle ranging from 15 degrees to 30 degrees relative to an axis that is defined through the first aperture.
Clause 18. The catheter of claim 14, wherein a length of the tapered surface ranges from 10 mm to 22 mm.
Clause 19. The catheter of claim 14, wherein the first section extends along about 5% to 22% of the length of the shaft.
Clause 20. The catheter of claim 14, further comprising a plurality of reinforcement elements coupled to the second section, an opening being defined between the concave wall and a surface of each of reinforcement element.
It is understood that the foregoing detailed description is merely illustrative and is not to be taken as limitations upon the scope of the invention, which is defined solely by the appended claims and their equivalents. Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art. Various features and advantages of the invention are set forth in the following claims.
This application is a non-provisional of and claims the benefit of U.S. Provisional Patent Application No. 62/727,373, filed on Sep. 5, 2018, the entire contents of which are incorporated herein by reference.
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/US2019/049716 | 9/5/2019 | WO | 00 |
Number | Date | Country | |
---|---|---|---|
62727373 | Sep 2018 | US |