Catheter and puncturing system comprising a catheter

Abstract

To provide a catheter usable in a medical procedure and a puncture system including the catheter.SOLUTION: The catheter includes an elongate shaft extending longitudinally between a proximal portion defining a proximal end and a distal portion defining a distal end. A lumen extends through the shaft from the proximal end to the distal end. The shaft includes a thermal barrier layer and an outer layer adjacent to the thermal barrier layer. The thermal barrier layer includes an inner liner layer adjacent the lumen and a thermal barrier layer adjacent the inner liner layer. In the distal portion, at least a section of the outer layer is radiopaque.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] This document relates to catheters, and more particularly to catheters that can be used in medical procedures and puncture systems that include catheters. Summary of the Invention

[0002] The following summary is intended to introduce the reader to various aspects of the detailed description, but does not define or delimit any invention. A catheter is disclosed. According to some embodiments, the catheter includes an elongate shaft extending longitudinally between a proximal portion defining a proximal end and a distal portion defining a distal end. A lumen extends through the shaft from the proximal end to the distal end. The shaft includes a thermal insulating layer and an outer layer adjacent to the thermal insulating layer. The thermal insulating layer includes an inner liner layer adjacent to the lumen and an intermediate layer adjacent to the inner liner layer. At least one section of the outer layer in the distal portion is radiopaque.

[0003] In some examples, the liner layer includes a first polymer, which may be or include polytetrafluoroethylene (PTFE).

[0004] In some examples, the intermediate layer includes a second polymer. The second polymer may be melt processable and flexible. The second polymer may be or may include at least one of polyether block amide (PEBA), aliphatic polyether-based thermoplastic polyurethane (TPU), nylon, polyurethane, and polyethylene. In some examples, the second polymer is polyether block amide.

[0005] In some examples, the outer layer includes a third polymer. The third polymer may be or may include at least one of polyether block amide (PEBA), aliphatic polyether-based thermoplastic polyurethane (TPU), nylon, polyurethane, and polyethylene. In some examples, the third polymer is polyether block amide (PEBA).

[0006] In some examples, in the radiopaque section, the third polymer is filled with a radiopaque filler. The radiopaque filler may be or may include at least one of tungsten, barium sulfate, and bismuth. In some examples, the radiopaque filler includes tungsten.

[0007] In some instances, the radiopaque section extends along the entire distal portion. In some instances, the radiopaque section includes a radiopaque band at the distal portion. The radiopaque band may be at the distal end.

[0008] In some examples, the distal portion has a length of about 1 mm to about 5 mm. In some instances, the liner layer, intermediate layer, and outer layer are of constant thickness between the proximal and distal ends.

[0009] In some examples, the proximal portion includes at least a first tapered section adjacent the distal portion, and the thickness of the outer layer tapers in the tapered section. In some instances, the distal portion is tapered.

[0010] A perforation system is also disclosed. According to some aspects, the perforation system includes a catheter, a perforation device, and a radiofrequency generator. The catheter includes an elongate shaft extending longitudinally between a proximal portion defining a proximal end and a distal portion defining a distal end, and a lumen extending through the shaft from the proximal end to the distal end. The shaft includes a thermally insulating layer and an outer layer adjacent to the thermally insulating layer. The thermally insulating layer includes an inner liner layer adjacent to the lumen and an intermediate layer adjacent to the inner liner layer. At least one section of the outer layer in the distal portion is radiopaque. The perforation device includes a shaft receivable within the catheter and has a heat-generating radiofrequency electrode positionable proximate the distal end of the catheter. The radiofrequency generator is connectable to the perforation device to supply radiofrequency energy to the radiofrequency electrode. [Brief explanation of the drawings]

[0011] The accompanying drawings are intended to illustrate, but not to limit, examples of the articles, methods, and apparatus of the present disclosure. [Figure 1] FIG. 1 is a perspective view of an exemplary drilling system. [Figure 2] FIG. 2 is a side view of the catheter of the system of FIG. 1, showing the lumen with a dotted line. [Figure 3] FIG. 3 is an enlarged, partial side view of the catheter of FIG. 2. [Figure 4] FIG. 4 is a cross-sectional view taken along line 4-4 in FIG. 3. [Figure 5] FIG. 1 is a partial side view of another exemplary catheter. [Figure 6] FIG. 6 is a cross-sectional view taken along line 6-6 of FIG. 5. [Figure 7] FIG. 1 is a partial side view of another exemplary catheter. [Figure 8] FIG. 8 is a cross-sectional view taken along line 8-8 of FIG. 7. DETAILED DESCRIPTION OF THE INVENTION

[0012] Various devices, processes, or configurations are described below to provide examples of embodiments of the claimed subject matter. The examples described below do not limit any claim, and any claim may cover processes, devices, or configurations different from those described below. The claims are not limited to all features of any one device, process, or configuration described below, or to devices, processes, or configurations having features common to more than one or all of the devices, processes, or configurations described below. The devices, processes, or configurations described below may not be embodiments of any exclusive rights granted by the issuance of this patent application. Any subject matter described below for which exclusive rights are not granted by the issuance of this patent application may be the subject of a separate protective document, e.g., a continuing patent application, and the applicant, inventor, or owner does not intend to relinquish, abandon, or make available to the public such subject matter by its disclosure in this document.

[0013] Generally, disclosed herein are catheters and related systems. The catheters can be used in various medical procedures, including, but not limited to, puncture procedures. As described in further detail below, the catheters disclosed herein have at least one radiopaque segment in a distal portion of the catheter. For example, the entire length of the distal portion may be radiopaque, or the distal portion may include one or more radiopaque bands. The radiopaque segment is visible under fluoroscopy during the medical procedure, facilitating proper positioning of the catheter. Furthermore, as described below, the distal portion is configured to shield the radiopaque segment from heat (e.g., heat generated by other medical devices). This may allow the radiopaque segment to be positioned at or near the distal end of the catheter while preventing or reducing damage to the radiopaque segment due to exposure to heat.

[0014] 1, there is shown an exemplary system 100. System 100 is a transseptal puncture system for advancing toward a patient's heart and puncturing the fossa ovalis of the patient's heart.

[0015] In the illustrated example, system 100 includes a catheter 102, a radiofrequency (RF) perforation device 104, and an RF generator 106. RF perforation device 104 includes an elongate body 108 and an RF electrode 110. RF perforation device 104 is connectable to RF generator 106 such that RF generator 106 can supply RF energy to RF electrode 110. Optionally, system 100 may further include a dilator (not shown).

[0016] In one example of use, the catheter 102 can be advanced intravenously via the femoral vein toward the right atrium of a patient's heart. The RF perforation device 104 can be connected to an RF generator 106, which can be connected to one or more grounding pads (not shown). The RF perforation device 104 can then be advanced through the catheter 102 (optionally via a dilator). When the catheter 102 is in a desired location within the patient's heart, for example, adjacent the fossa ovalis, the RF perforation device 104 can be advanced to position the RF electrode 110 adjacent the fossa ovalis, and the RF generator 106 can be activated to deliver RF energy to the RF electrode 110 to perforate the fossa ovalis. Such a procedure can be performed, for example, as a therapy or to gain access to the left atrium for subsequent therapy.

[0017] As described above and in further detail below, the catheter 102 may include at least one radiopaque section in a distal portion of the catheter 102. During a procedure, the position of the catheter 102 within the patient's body may be confirmed, determined, or checked using fluoroscopy by visualizing the radiopaque section. However, delivery of RF energy may cause significant heat generation by the RF electrode 110 (i.e., the RF electrode generates heat), and the heat may cause damage to the radiopaque material. Therefore, the catheter 102 is configured such that the radiopaque section is shielded from the heat generated by the RF electrode 110.

[0018] 2, the catheter 102 is shown in greater detail. In the illustrated example, the catheter 102 includes an elongate shaft 112 and a handle 114. The shaft 112 extends longitudinally between a proximal portion 116, which defines a proximal end 118, and a distal portion 120, which defines a distal end 122. The handle 114 is attached to the proximal end 118.

[0019] In the illustrated example, the proximal portion 116 occupies the majority of the length of the shaft 112, and the distal portion 120 occupies a relatively small portion of the length. For example, the proximal portion 116 may be long enough to extend between the femoral vein and the heart (e.g., about 250 cm), while the distal portion 120 may be only a few centimeters (e.g., 1 cm to 5 cm, or about 3 cm).

[0020] 2, in the illustrated example, the catheter 102 includes a lumen 124 (shown in dotted lines) that extends through the shaft 112 from the proximal end 118 to the distal end 122. The lumen 124 can accommodate the RF perforation device 104 and various other medical devices, such as a dilator.

[0021] As described below, the shaft 112 includes multiple layers, at least one of which includes a radiopaque segment, and at least another of which is configured as a thermal barrier to shield the radiopaque segment from heat.

[0022] 3 and 4, in the illustrated example, the shaft 112 includes a thermal barrier layer consisting of two sublayers: an inner liner layer 126 and an intermediate layer 128. The inner liner layer 126 is adjacent to and defines the lumen 124. In the illustrated example, the liner layer 126 extends from the proximal end 118 (not shown in FIGS. 3 and 4) to the distal end 122. In alternative examples, the liner layer may extend along only a portion of the shaft (e.g., the liner layer may extend along only the distal portion, with the proximal portion being of a different configuration). The liner layer 126 may be a polymer (referred to herein as a “first polymer”) or may include a polymer. The first polymer may be any suitable polymer that, when laminated with the intermediate layer 128, can shield additional layers from heat emanating from a medical device received within the catheter 102. For example, the first polymer can be polytetrafluoroethylene (PTFE).

[0023] Continuing with reference to FIGS. 3 and 4, intermediate layer 128 is adjacent to liner layer 126. In the illustrated example, intermediate layer 128 extends from proximal end 118 (not shown in FIGS. 3 and 4) to distal end 122. In alternative examples, intermediate layer 128 may extend along only a portion of the shaft (e.g., intermediate layer may extend along only the distal portion, with the proximal portion being of a different configuration). Intermediate layer 128 may be a polymer (referred to herein as a “second polymer”; the second polymer may be the same as or different from the first polymer) or may include a polymer. The second polymer may be any suitable polymer that, when laminated with the first polymer, can shield the additional layer from heat emanating from a medical device received within catheter 102. Additionally, the second polymer may be flexible to facilitate manipulation of the catheter 102 and may be melt-processable to facilitate manufacturing of the catheter 102 by melt-flowing the second polymer onto the liner layer 126. In some examples, the second polymer may be or include polyether block amide (PEBA) (e.g., polymers sold under the brand name PEBAX®), aliphatic polyether-based thermoplastic polyurethane (TPU) (e.g., polymers sold under the brand tam Tecoflex®), nylon, polyurethane, and / or polyethylene. In one particular example, the second polymer is PEBA.

[0024] 3 and 4, shaft 112 further includes an outer layer 130 adjacent to intermediate layer 128. In the illustrated example, outer layer 130 extends from proximal end 118 (not shown in FIGS. 3 and 4) to distal end 122. In alternative examples, the outer layer may extend along only a portion of the shaft (e.g., the outer layer may extend along only the distal portion, with the proximal portion being of a different configuration).

[0025] Generally, at least one section (also referred to herein as the "radiopaque section") of the outer layer 130 is radiopaque in the distal portion 120. With reference to Figures 3 and 4, in the illustrated example, the radiopaque section 132 extends along the entirety of the distal portion 120. However, in alternative examples, the outer layer may include a relatively small radiopaque band in the distal portion, or multiple spaced apart radiopaque bands (as described below).

[0026] Continuing with reference to FIGS. 3 and 4 , the outer layer 130 may be or include a third polymer (which may be the same as or different from the first and second polymers). In the radiopaque section 132, the third polymer may be filled with a radiopaque filler. The third polymer may be flexible to facilitate manipulation of the catheter 102 and may be melt-processable to facilitate manufacturing of the catheter 102 by melt-flowing the third polymer onto the intermediate layer 128. For example, the third polymer may be or include PEBA, TPU, nylon, polyurethane, and polyethylene. In one particular example, the third polymer and the second polymer are both PEBA. Furthermore, in the radiopaque section 132, the third polymer may be filled with a radiopaque filler, such as tungsten, barium sulfate, and / or bismuth. In one particular example, the radiopaque section includes PEBA filled with 80% tungsten by weight.

[0027] In the illustrated example, the liner layer 126, the middle layer 128, and the outer layer 130 are of constant thickness between the proximal end 118 and the distal end 122. In alternative examples, as described below, the thickness of one or more of the layers may vary. For example, one or more of the layers may be tapered.

[0028] In the illustrated example, the liner layer 126, the middle layer 128, and the outer layer 130 all extend to the distal end 122 of the shaft. Alternatively, one or more of these layers may extend slightly short of the distal end of the shaft. For example, the inner liner layer may extend to and define the distal end of the shaft. The middle and outer layers may extend slightly short of the distal end of the shaft, i.e., the inner liner layer extends beyond the middle and outer layers. This may further shield the radiopaque section of the outer layer from heat.

[0029] 5 and 6, an alternative embodiment of the catheter is shown. In FIG. 5, features similar to those in FIGS. 1-4 are referenced with similar reference numerals incremented by 400. 1-4, the catheter 502 of Figures 5 and 6 includes an elongate shaft 508 having a proximal portion 516 defining a proximal end (not shown) and a distal portion 520 defining a distal end 522. The shaft 508 includes a liner layer 526 and an intermediate layer 528 that form a thermal barrier, and an outer layer 530. The catheter 502 further includes a lumen 524.

[0030] 5 and 6, in distal portion 520, outer layer 530 includes a set of radiopaque bands 534a-534c. Similar to radiopaque section 132 of FIGS. 1-4, radiopaque bands 534a-534c may be formed by filling the polymer of outer layer 530 with a radiopaque filler material. In the illustrated example, outer layer 530 includes a first radiopaque band 534a at distal end 522 and a second radiopaque band 534b and a third radiopaque band 534c spaced proximally from first radiopaque band 534a.

[0031] 5 and 6, in the illustrated example, the shaft 508 includes two tapered sections such that the distal end 522 is provided with a smaller profile than the proximal end. Specifically, the proximal portion 516 includes a first tapered section 536 adjacent the distal portion 520. Within the first tapered section 536, the thickness of the outer layer 530 tapers. Additionally, the distal portion 520 includes a second tapered section 538 at the distal end 522. Within the second tapered section 538, the thickness of the outer layer 530 also tapers. The second tapered section 538 includes a first radiopaque band 534a.

[0032] Referring now to Figures 7 and 8, an alternative embodiment of the catheter is shown. In Figures 7 and 8, features similar to those in Figures 5 and 6 are referenced with similar reference numerals incremented by 200.

[0033] Similar to the catheter of Figures 5 and 6, the catheter 702 of Figures 7 and 8 includes an elongate shaft 708 having a proximal portion 716 defining a proximal end (not shown) and a distal portion 720 defining a distal end 722. The shaft 708 includes a liner layer 726 and an intermediate layer 728 that form a thermal barrier, and an outer layer 730. The catheter 702 further includes a lumen 724.

[0034] 7 and 8, in distal portion 720, outer layer 730 includes a set of radiopaque bands 734a-734c. Similar to radiopaque section 132 of FIGS. 1-4, radiopaque bands 734a-734c may be formed by filling the polymer of outer layer 730 with a radiopaque filler material. In the illustrated example, outer layer 730 includes a first radiopaque band 734a at distal end 722 and a second radiopaque band 734b and a third radiopaque band 734c spaced proximally from first radiopaque band 734a.

[0035] 7 and 8, in the illustrated example, the entire distal portion 720 is tapered to provide a distal end 722 with a smaller profile than the proximal end. In particular, the liner layer 726 is stepped in the distal portion 720 to provide a smaller cross-sectional area at the distal end 722. Additionally, the middle layer 728 tapers in diameter area toward the distal end 722. Finally, the thickness of the outer layer 730, including the radiopaque bands 734a-c, tapers toward the distal end 722.

[0036] While the above description provides examples of one or more processes or devices or configurations, it will be understood that other processes or devices or configurations may be within the scope of the following claims.

[0037] To the extent that any amendment, characterization, or other statement previously made (in this patent or any related patent application or patent, including any parent, sibling, or progeny patent) regarding any technology, prior art, or otherwise may be construed as a disclaimer of any subject matter supported by the present disclosure of this application, Applicant hereby cancels and revokes such disclaimer. Applicant also respectfully submits that any prior art previously considered may need to be re-referenced in any related patent application or patent, including any parent, sibling, or progeny patent.

Claims

1. an elongate shaft extending longitudinally between a proximal portion defining a proximal end and a distal portion defining a distal end; a lumen extending through the shaft from the proximal end to the distal end, the shaft includes a thermal barrier layer and an outer layer adjacent to the thermal barrier layer; the thermal barrier layer includes an inner liner layer adjacent to the lumen and an intermediate layer adjacent to the inner liner layer; A catheter wherein at least one section of the outer layer in the distal portion is radiopaque.

2. The catheter of claim 1 , wherein the liner layer comprises a first polymer.

3. The catheter of claim 2 , wherein the first polymer comprises polytetrafluoroethylene (PTFE).

4. The catheter of claim 1 , wherein the intermediate layer comprises a second polymer, the second polymer being melt-processable and flexible.

5. 5. The catheter of claim 4, wherein the second polymer comprises at least one of polyether block amide (PEBA), aliphatic polyether-based thermoplastic polyurethane (TPU), nylon, polyurethane, and polyethylene.

6. The catheter of claim 5 , wherein the second polymer comprises a polyether block amide.

7. The catheter of claim 1 , wherein the outer layer comprises a third polymer.

8. 8. The catheter of claim 7, wherein the third polymer comprises at least one of polyether block amide (PEBA), aliphatic polyether-based thermoplastic polyurethane (TPU), nylon, polyurethane, and polyethylene.

9. The catheter of claim 7 , wherein the third polymer comprises polyether block amide (PEBA).

10. The catheter of claim 1 , wherein in the section that is radiopaque, the third polymer is filled with a radiopaque filler material.

11. The catheter of claim 10 , wherein the radiopaque filler material comprises at least one of tungsten, barium sulfate, and bismuth.

12. The catheter of claim 11 , wherein the radiopaque filler comprises tungsten.

13. The catheter of claim 1 , wherein the radiopaque section extends along the entire distal portion.

14. The catheter of claim 8 , wherein the section that is radiopaque includes a radiopaque band in the distal portion.

15. The catheter of claim 14 , wherein the radiopaque band is at the distal end.

16. The catheter of claim 1 , wherein the distal portion has a length of about 1 mm to about 5 mm.

17. The catheter of claim 1 , wherein the liner layer, the intermediate layer, and the outer layer are of constant thickness between the proximal end and the distal end.

18. The catheter of claim 1 , wherein the proximal portion includes at least a first tapered section adjacent the distal portion, and the thickness of the outer layer tapers in the tapered section.

19. The catheter of claim 1 , wherein the distal portion is tapered.

20. a catheter including: i) an elongate shaft extending longitudinally between a proximal portion defining a proximal end and a distal portion defining a distal end; and ii) a lumen extending through the shaft from the proximal end to the distal end, the shaft including a thermal insulating layer and an outer layer adjacent to the thermal insulating layer, the thermal insulating layer including an inner liner layer adjacent to the lumen and an intermediate layer adjacent to the inner liner layer, wherein at least one section of the outer layer in the distal portion is radiopaque; a piercing device including an elongate body receivable within the catheter and having a heat-generating radiofrequency electrode positionable proximate the distal end of the catheter; a radio frequency generator connectable to the radio frequency electrode to supply radio frequency energy to the radio frequency electrode.

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