CA3125876A1 - System of medical devices and method for pericardial puncture - Google Patents
System of medical devices and method for pericardial puncture Download PDFInfo
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- CA3125876A1 CA3125876A1 CA3125876A CA3125876A CA3125876A1 CA 3125876 A1 CA3125876 A1 CA 3125876A1 CA 3125876 A CA3125876 A CA 3125876A CA 3125876 A CA3125876 A CA 3125876A CA 3125876 A1 CA3125876 A1 CA 3125876A1
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- introducer
- puncture device
- distal end
- catch
- puncturing tip
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- 238000000034 method Methods 0.000 title claims description 26
- 210000003516 pericardium Anatomy 0.000 claims description 15
- 238000002594 fluoroscopy Methods 0.000 claims description 4
- 239000003550 marker Substances 0.000 claims description 2
- 239000000203 mixture Substances 0.000 description 8
- 210000001519 tissue Anatomy 0.000 description 5
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- 238000002679 ablation Methods 0.000 description 1
- 210000000577 adipose tissue Anatomy 0.000 description 1
- 238000012512 characterization method Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 230000002439 hemostatic effect Effects 0.000 description 1
- 229920001903 high density polyethylene Polymers 0.000 description 1
- 239000004700 high-density polyethylene Substances 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
Abstract
A system of medical devices includes a puncture device and an introducer. The puncture device extends from a puncture device proximal end to a puncture device distal end and has a puncturing tip at the puncture device distal end. The introducer extends from an introducer proximal end to an introducer distal end, and has a lumen extending therethrough from the introducer proximal end to the introducer distal end. The puncture device is advanceable through the lumen from the introducer proximal end towards the introducer distal end to position the puncturing tip proud of the introducer distal end. The puncture device is engageable with the introducer to limit advancement of the puncturing tip out of the introducer distal end beyond a predetermined distance.
Description
SYSTEM OF MEDICAL DEVICES AND METHOD FOR PERICARDIAL PUNCTURE
FIELD:
[0001]This document relates to medical devices. More specifically, this document relates to systems of medical devices that can be used in pericardial puncture, and related methods.
SUMMARY:
FIELD:
[0001]This document relates to medical devices. More specifically, this document relates to systems of medical devices that can be used in pericardial puncture, and related methods.
SUMMARY:
[0002]The following summary is intended to introduce the reader to various aspects of the detailed description, but not to define or delimit any invention.
[0003]Systems of medical devices are disclosed. According to some aspects, a system of medical devices includes a puncture device extending from a puncture device proximal end to a puncture device distal end. The puncture device includes a puncturing tip at the puncture device distal end. The system further includes an introducer extending from an introducer proximal end to an introducer distal end. The introducer has a lumen extending therethrough from the introducer proximal end to the introducer distal end.
The puncture device is advanceable through the lumen from the introducer proximal end towards the introducer distal end to position the puncturing tip proud of the introducer distal end. The puncture device is engageable with the introducer to limit advancement of the puncturing tip out of the introducer distal end beyond a predetermined distance.
The puncture device is advanceable through the lumen from the introducer proximal end towards the introducer distal end to position the puncturing tip proud of the introducer distal end. The puncture device is engageable with the introducer to limit advancement of the puncturing tip out of the introducer distal end beyond a predetermined distance.
[0004] In some examples, the puncture device includes a first catch, the introducer includes a second catch, and the first catch is engageable with the second catch to limit advancement of the puncturing tip out of the introducer distal end beyond the predetermined distance.
[0005]In some examples, the puncture device has a puncture device distal portion defining the puncture device distal end, and the first catch is in the puncture device distal portion. In some examples, the introducer has an introducer distal portion defining the introducer distal end, and the second catch is in the introducer distal portion.
Date Recue/Date Received 2021-07-26
Date Recue/Date Received 2021-07-26
[0006] In some examples, the puncture device is stepped to define a distally facing shoulder, and the first catch includes the distally facing shoulder. In some examples, the lumen is stepped to define a proximally facing internal edge, and the second catch includes the proximally facing internal edge. The distally facing shoulder can abut the proximally facing internal edge to limit advancement of the puncturing tip out of the introducer distal end beyond the predetermined distance.
[0007] In some examples, the predetermined distance is between about 1 mm and about 3 mm.
[0008] In some examples, the puncture device distal end is sharpened to provide the puncturing tip.
[0009] In some examples, the introducer has an introducer length between the introducer proximal end and the introducer distal end, the puncture device has a puncture device length between the puncture device proximal end and the puncture device distal end, and the introducer length is less than the puncture device length.
[0010] In some examples, the introducer distal end is blunt.
[0011]In some examples, the introducer includes a metallic tube embedded in a polymeric sheathing.
[0012] In some examples, at least one of the introducer and the puncture device includes a radiopaque marker.
[0013] Methods for pericardial puncture are also disclosed. According to some aspects, a method for pericardial puncture includes: a. positioning a distal end of an introducer adjacent a pericardium; b. advancing a puncturing tip of a puncture device out of the introducer to puncture the pericardium with the puncturing tip; and c.
engaging the introducer with the puncture device to prevent advancement of the puncturing tip out of the introducer beyond a predetermined distance.
Date Recue/Date Received 2021-07-26
engaging the introducer with the puncture device to prevent advancement of the puncturing tip out of the introducer beyond a predetermined distance.
Date Recue/Date Received 2021-07-26
[0014] In some examples, step c. includes engaging a first catch of the puncture device with a second catch of the introducer. Step c. can include abutting a shoulder of the puncture device with an edge of the introducer.
[0015] In some examples, the predetermined distance is between about 1 mm and about 3 mm.
[0016]In some examples, step b. includes advancing a sharpened distal end of the puncture device out of the introducer.
[0017] In some examples, the method further includes, prior to step b., confirming the position of the distal end of the introducer using fluoroscopy.
[0018] In some examples, the method further includes, after step c., withdrawing the puncture device from the introducer.
[0019] BRIEF DESCRIPTION OF THE DRAWINGS:
[0020]The accompanying drawings are for illustrating examples of articles, methods, and apparatuses of the present disclosure and are not intended to be limiting. In the drawings:
[0021] Figure 1 is a perspective view of an example system of medical devices;
[0022] Figure 2 is a perspective view of the puncture device of the system of Figure 1;
[0023] Figure 3 is a cross-section taken along line 3-3 in Figure 2;
[0024] Figure 4 is a perspective view of the introducer of the system of Figure 1;
[0025] Figure 5 is a cross-section taken along line 5-5 in Figure 4; and
[0026] Figure 6 is a cross-section taken along line 6-6 in Figure 1 DETAILED DESCRIPTION:
[0027]Various apparatuses or processes or compositions will be described below to provide an example of an embodiment of the claimed subject matter. No example Date Recue/Date Received 2021-07-26 described below limits any claim and any claim may cover processes or apparatuses or compositions that differ from those described below. The claims are not limited to apparatuses or processes or compositions having all of the features of any one apparatus or process or composition described below or to features common to multiple or all of the apparatuses or processes or compositions described below. It is possible that an apparatus or process or composition described below is not an embodiment of any exclusive right granted by issuance of this patent application. Any subject matter described below and for which an exclusive right is not granted by issuance of this patent application may be the subject matter of another protective instrument, for example, a continuing patent application, and the applicants, inventors or owners do not intend to abandon, disclaim or dedicate to the public any such subject matter by its disclosure in this document.
[0028]Generally disclosed herein is a system of medical devices that includes an introducer and a puncture device. The system can be used, for example, in pericardial puncture procedures. In such procedures, the introducer can be advanced towards a patient's heart, with the puncture device received in the introducer. When the introducer is in contact with the patient's heart, the puncture device can be advanced out of the introducer, in order to puncture the pericardium. The system disclosed herein is configured such that the extent to which the puncture device can be advanced out of the introducer is limited. For example, the puncture device can in some examples be advanced out of the introducer by only up to 3 mm. By limiting the extent to which the puncture device can be advanced out of the introducer, the risk of inadvertently puncturing tissues deeper within the heart, such as the epicardium, is reduced. The system disclosed herein can thus enhance ease of use and can enhance patient safety
[0029] Referring now to Figure 1, an example system 100 of medical devices is shown.
The system 100 generally includes a puncture device 102 and an introducer 104.
The puncture device 102 is receivable in and advanceable through the introducer 104. The introducer 104 can serve to atraumatically guide the puncture device 102 towards a target location in a patient's body (e.g. the heart), and the puncture device 102 can then puncture the target location (e.g. puncture the pericardium).
Date Recue/Date Received 2021-07-26
The system 100 generally includes a puncture device 102 and an introducer 104.
The puncture device 102 is receivable in and advanceable through the introducer 104. The introducer 104 can serve to atraumatically guide the puncture device 102 towards a target location in a patient's body (e.g. the heart), and the puncture device 102 can then puncture the target location (e.g. puncture the pericardium).
Date Recue/Date Received 2021-07-26
[0030] Referring now to Figures 2 and 3, the puncture device 102 extends along a longitudinal axis 106 and has a proximal portion 108 (also referred to herein as a 'puncture device proximal portion'), which defines a proximal end 110 (also referred to herein as a 'puncture device proximal end'), and a distal portion 112 (also referred to herein as a 'puncture device distal portion'), which defines a distal end 114 (also referred to herein as a 'puncture device distal end). The puncture device 102 has a length (also referred to herein as a 'length length') between the proximal end 110 and the distal end 114.
[0031 ] Referring still to Figures 2 and 3, the puncture device 102 includes a shaft 116 (e.g. a stainless-steel shaft) and a hub 118. The hub 118 defines the puncture device proximal end 110, while the shaft 116 defines the puncture device distal end 114. The hub 118 can be used to grasp and manipulate the puncture device 102.
[0032] Referring still to Figures 2 and 3, the puncture device 102 has a puncturing tip 117 at the distal end 114. In the example shown, the puncture device 102 is a mechanical puncture device, and the distal end 114 is sharpened to provide the puncturing tip 117.
For example, the distal end 114 can be conical (as shown), beveled, or pyramidal. In alternative examples, the puncture device can be a radiofrequency puncture device, and the puncturing tip can include a radiofrequency electrode.
[0033] Referring now to Figures 4 and 5, the introducer 104 extends along a longitudinal axis 120 and has a proximal portion 122 (also referred to herein as an 'introducer proximal portion'), which defines a proximal end 124 (also referred to herein as an 'introducer proximal end'), and a distal portion 126 (also referred to herein as an 'introducer distal portion'), which defines a distal end 128 (also referred to herein as an 'introducer distal end). The introducer 104 has a length (also referred to herein as an 'introducer length') between the proximal end 124 and the distal end 128, and the introducer length is less than the puncture device length. A lumen 130 (shown in Figure 5) extends through the introducer 104 from the proximal end 124 to the distal end 128, for receiving the puncture device 102.
[0034] Referring still to Figures 4 and 5, in the example shown, the introducer 104 includes a shaft 132 (also referred to herein as an 'introducer shaft') and a hub 134 (also referred Date Recue/Date Received 2021-07-26 to herein as an 'introducer hub'). The hub 134 defines the introducer proximal end 124 while the shaft 132 defines the introducer distal end 128. The hub 134 may include various features, such as fluid ports and hemostatic valves, etc. (not shown). As shown in Figure 5, the shaft 132 includes a metallic tube 136 (e.g. a stainless steel hypotube), and a polymeric sheathing 138 (e.g. a high-density polyethylene sheathing) on the tube 136. In use, the hub 134 may be grasped and manipulated by the user, while the distal portion 126 is directed to a target site within a patient's body (e.g. the heart). The distal end 128 is blunt, to avoid damaging tissue in contact with the distal end 128.
[0035] Referring now to Figures 1 and 6, the puncture device 102 is advanceable through the lumen 130 (not labelled in Figure 6) of the introducer 104, from the introducer proximal end 124 towards the introducer distal end 128, to position the puncturing tip 117 proud of the introducer distal end 128. When the introducer distal end 128 is in contact with a tissue (e.g. the pericardium), the puncturing tip 117 can be advanced proud of the introducer distal end 128 in order to puncture the tissue. However, it may be desired to advance the puncturing tip 117 proud of the introducer distal end 128 by only a limited distance, in order to avoid puncturing of deeper tissue (e.g. the epicardium).
Accordingly, the introducer 104 and puncture device 102 are configured to engage to limit advancement of the puncturing tip 117 out of the introducer distal end 128 beyond a predetermined distance (e.g. a distance of up to 3 mm, or a distance of between about 1 mm and about 3 mm). For example, the puncture device 102 can include a first catch, the introducer 104 can include a second catch, and the first catch can be engageable with the second catch to limit advancement of the puncturing tip 117 out of the introducer distal end 128 beyond a predetermined distance. More specifically, referring to Figure 3, in the example shown the shaft 116 of the puncture device 102 is stepped to define a distally facing shoulder 140 in the puncture device distal portion 112. The distally facing shoulder 140 serves as a first catch. Furthermore, referring to Figure 5, the lumen 130 of the introducer 104 is stepped to define a proximally facing internal edge 142 in the introducer distal portion 126. The proximally facing internal edge 142 serves as a second catch. As shown in Figure 6, as the puncture device 102 is advanced through the introducer 104 to position the puncturing tip 117 proud of the introducer distal end 128, the distally facing shoulder 140 abuts the proximally facing internal edge 142 to limit advancement of the Date Recue/Date Received 2021-07-26 puncturing tip 117 out of the introducer distal end 128 beyond a predetermined distance D.
[0036] In any of the above examples, the introducer 104 and/or the puncture device 102 can include one or more radiopaque markers (not shown), to facilitate viewing of the system 100 under fluoroscopy.
[0037] In one particular example of use, the introducer 104 can be percutaneously advanced towards a target location in a patient's body (e.g. towards the pericardium via the subxiphoid approach). The puncture device 102 can be advanced together with the introducer 104, with the puncture device 102 in the lumen 130 and with puncturing tip 117 proud of the introducer distal end 128, so that the puncture device 102 facilitates piercing of adipose tissue etc. (however, in alternative examples, the puncture device 102 may be advanced after the introducer 104). The puncture device 102 and introducer 104 can be advanced until the introducer 104 and puncture device 102 are proximate the pericardium. The puncture device 102 can then be retracted slightly, so that the puncturing tip 117 is shy of or flush with the introducer distal end 128.
Advancement can then continue until the introducer distal end 128 is positioned adjacent the pericardium, so that the introducer distal end 128 first contacts the pericardium.
Optionally, fluoroscopy can be used to confirm the position of the distal end 128 of the introducer 104 and/or the distal end 114 of the puncture device 102.
[0038] With the distal end 128 of the introducer 104 positioned adjacent the pericardium, the puncturing tip 117 of the puncture device 102 can be advanced out of the introducer 104 to puncture the pericardium with the puncturing tip 117. As the puncturing tip 117 is advanced, the introducer 104 will engage with the puncture device 102, to prevent advancement of the puncturing tip 117 out of the introducer 104 beyond the predetermined distance D (e.g. beyond up to 3 mm, or between about 1 mm and about 3 mm). More specifically, the shoulder 140 of the puncture device 102 will abut the edge 142 of the introducer 104, to prevent advancement of the puncturing tip 117 out of the introducer 104 beyond the predetermined distance D.
Date Recue/Date Received 2021-07-26 [0039]Abutting of the shoulder 140 of the puncture device 102 with the edge 142 of the introducer 104 can provide tactile feedback to the user, to indicate that the puncture device 102 is fully advanced and the pericardium has been punctured. When the pericardium has been punctured, the puncture device 102 can be withdrawn from the introducer 104, and a subsequent medical procedure can be carried out (e.g.
various other medical devices (e.g. a guidewire and/or an ablation catheter) can be advanced through the introducer 104).
[0040] While the above description provides examples of one or more processes or apparatuses or compositions, it will be appreciated that other processes or apparatuses or compositions may be within the scope of the accompanying claims.
[0041]To the extent any amendments, characterizations, or other assertions previously made (in this or in any related patent applications or patents, including any parent, sibling, or child) with respect to any art, prior or otherwise, could be construed as a disclaimer of any subject matter supported by the present disclosure of this application, Applicant hereby rescinds and retracts such disclaimer. Applicant also respectfully submits that any prior art previously considered in any related patent applications or patents, including any parent, sibling, or child, may need to be re-visited.
Date Recue/Date Received 2021-07-26
[0031 ] Referring still to Figures 2 and 3, the puncture device 102 includes a shaft 116 (e.g. a stainless-steel shaft) and a hub 118. The hub 118 defines the puncture device proximal end 110, while the shaft 116 defines the puncture device distal end 114. The hub 118 can be used to grasp and manipulate the puncture device 102.
[0032] Referring still to Figures 2 and 3, the puncture device 102 has a puncturing tip 117 at the distal end 114. In the example shown, the puncture device 102 is a mechanical puncture device, and the distal end 114 is sharpened to provide the puncturing tip 117.
For example, the distal end 114 can be conical (as shown), beveled, or pyramidal. In alternative examples, the puncture device can be a radiofrequency puncture device, and the puncturing tip can include a radiofrequency electrode.
[0033] Referring now to Figures 4 and 5, the introducer 104 extends along a longitudinal axis 120 and has a proximal portion 122 (also referred to herein as an 'introducer proximal portion'), which defines a proximal end 124 (also referred to herein as an 'introducer proximal end'), and a distal portion 126 (also referred to herein as an 'introducer distal portion'), which defines a distal end 128 (also referred to herein as an 'introducer distal end). The introducer 104 has a length (also referred to herein as an 'introducer length') between the proximal end 124 and the distal end 128, and the introducer length is less than the puncture device length. A lumen 130 (shown in Figure 5) extends through the introducer 104 from the proximal end 124 to the distal end 128, for receiving the puncture device 102.
[0034] Referring still to Figures 4 and 5, in the example shown, the introducer 104 includes a shaft 132 (also referred to herein as an 'introducer shaft') and a hub 134 (also referred Date Recue/Date Received 2021-07-26 to herein as an 'introducer hub'). The hub 134 defines the introducer proximal end 124 while the shaft 132 defines the introducer distal end 128. The hub 134 may include various features, such as fluid ports and hemostatic valves, etc. (not shown). As shown in Figure 5, the shaft 132 includes a metallic tube 136 (e.g. a stainless steel hypotube), and a polymeric sheathing 138 (e.g. a high-density polyethylene sheathing) on the tube 136. In use, the hub 134 may be grasped and manipulated by the user, while the distal portion 126 is directed to a target site within a patient's body (e.g. the heart). The distal end 128 is blunt, to avoid damaging tissue in contact with the distal end 128.
[0035] Referring now to Figures 1 and 6, the puncture device 102 is advanceable through the lumen 130 (not labelled in Figure 6) of the introducer 104, from the introducer proximal end 124 towards the introducer distal end 128, to position the puncturing tip 117 proud of the introducer distal end 128. When the introducer distal end 128 is in contact with a tissue (e.g. the pericardium), the puncturing tip 117 can be advanced proud of the introducer distal end 128 in order to puncture the tissue. However, it may be desired to advance the puncturing tip 117 proud of the introducer distal end 128 by only a limited distance, in order to avoid puncturing of deeper tissue (e.g. the epicardium).
Accordingly, the introducer 104 and puncture device 102 are configured to engage to limit advancement of the puncturing tip 117 out of the introducer distal end 128 beyond a predetermined distance (e.g. a distance of up to 3 mm, or a distance of between about 1 mm and about 3 mm). For example, the puncture device 102 can include a first catch, the introducer 104 can include a second catch, and the first catch can be engageable with the second catch to limit advancement of the puncturing tip 117 out of the introducer distal end 128 beyond a predetermined distance. More specifically, referring to Figure 3, in the example shown the shaft 116 of the puncture device 102 is stepped to define a distally facing shoulder 140 in the puncture device distal portion 112. The distally facing shoulder 140 serves as a first catch. Furthermore, referring to Figure 5, the lumen 130 of the introducer 104 is stepped to define a proximally facing internal edge 142 in the introducer distal portion 126. The proximally facing internal edge 142 serves as a second catch. As shown in Figure 6, as the puncture device 102 is advanced through the introducer 104 to position the puncturing tip 117 proud of the introducer distal end 128, the distally facing shoulder 140 abuts the proximally facing internal edge 142 to limit advancement of the Date Recue/Date Received 2021-07-26 puncturing tip 117 out of the introducer distal end 128 beyond a predetermined distance D.
[0036] In any of the above examples, the introducer 104 and/or the puncture device 102 can include one or more radiopaque markers (not shown), to facilitate viewing of the system 100 under fluoroscopy.
[0037] In one particular example of use, the introducer 104 can be percutaneously advanced towards a target location in a patient's body (e.g. towards the pericardium via the subxiphoid approach). The puncture device 102 can be advanced together with the introducer 104, with the puncture device 102 in the lumen 130 and with puncturing tip 117 proud of the introducer distal end 128, so that the puncture device 102 facilitates piercing of adipose tissue etc. (however, in alternative examples, the puncture device 102 may be advanced after the introducer 104). The puncture device 102 and introducer 104 can be advanced until the introducer 104 and puncture device 102 are proximate the pericardium. The puncture device 102 can then be retracted slightly, so that the puncturing tip 117 is shy of or flush with the introducer distal end 128.
Advancement can then continue until the introducer distal end 128 is positioned adjacent the pericardium, so that the introducer distal end 128 first contacts the pericardium.
Optionally, fluoroscopy can be used to confirm the position of the distal end 128 of the introducer 104 and/or the distal end 114 of the puncture device 102.
[0038] With the distal end 128 of the introducer 104 positioned adjacent the pericardium, the puncturing tip 117 of the puncture device 102 can be advanced out of the introducer 104 to puncture the pericardium with the puncturing tip 117. As the puncturing tip 117 is advanced, the introducer 104 will engage with the puncture device 102, to prevent advancement of the puncturing tip 117 out of the introducer 104 beyond the predetermined distance D (e.g. beyond up to 3 mm, or between about 1 mm and about 3 mm). More specifically, the shoulder 140 of the puncture device 102 will abut the edge 142 of the introducer 104, to prevent advancement of the puncturing tip 117 out of the introducer 104 beyond the predetermined distance D.
Date Recue/Date Received 2021-07-26 [0039]Abutting of the shoulder 140 of the puncture device 102 with the edge 142 of the introducer 104 can provide tactile feedback to the user, to indicate that the puncture device 102 is fully advanced and the pericardium has been punctured. When the pericardium has been punctured, the puncture device 102 can be withdrawn from the introducer 104, and a subsequent medical procedure can be carried out (e.g.
various other medical devices (e.g. a guidewire and/or an ablation catheter) can be advanced through the introducer 104).
[0040] While the above description provides examples of one or more processes or apparatuses or compositions, it will be appreciated that other processes or apparatuses or compositions may be within the scope of the accompanying claims.
[0041]To the extent any amendments, characterizations, or other assertions previously made (in this or in any related patent applications or patents, including any parent, sibling, or child) with respect to any art, prior or otherwise, could be construed as a disclaimer of any subject matter supported by the present disclosure of this application, Applicant hereby rescinds and retracts such disclaimer. Applicant also respectfully submits that any prior art previously considered in any related patent applications or patents, including any parent, sibling, or child, may need to be re-visited.
Date Recue/Date Received 2021-07-26
Claims (20)
1. A system of medical devices, comprising:
a puncture device extending from a puncture device proximal end to a puncture device distal end, wherein the puncture device comprises a puncturing tip at the puncture device distal end; and an introducer extending from an introducer proximal end to an introducer distal end, wherein the introducer has a lumen extending therethrough from the introducer proximal end to the introducer distal end;
wherein the puncture device is advanceable through the lumen from the introducer proximal end towards the introducer distal end to position the puncturing tip proud of the introducer distal end; and wherein the puncture device is engageable with the introducer to limit advancement of the puncturing tip out of the introducer distal end beyond a predetermined distance.
a puncture device extending from a puncture device proximal end to a puncture device distal end, wherein the puncture device comprises a puncturing tip at the puncture device distal end; and an introducer extending from an introducer proximal end to an introducer distal end, wherein the introducer has a lumen extending therethrough from the introducer proximal end to the introducer distal end;
wherein the puncture device is advanceable through the lumen from the introducer proximal end towards the introducer distal end to position the puncturing tip proud of the introducer distal end; and wherein the puncture device is engageable with the introducer to limit advancement of the puncturing tip out of the introducer distal end beyond a predetermined distance.
2. The system of claim 1, wherein the puncture device comprises a first catch, the introducer comprises a second catch, and the first catch is engageable with the second catch to limit advancement of the puncturing tip out of the introducer distal end beyond the predetermined distance.
3. The system of claim 2, wherein the puncture device has a puncture device distal portion defining the puncture device distal end, and the first catch is in the puncture device distal portion.
4. The system of claim 2, wherein the introducer has an introducer distal portion defining the introducer distal end, and the second catch is in the introducer distal portion.
5. The system of claim 2, wherein the puncture device is stepped to define a distally facing shoulder, and the first catch comprises the distally facing shoulder.
6. The system of claim 5, wherein the lumen is stepped to define a proximally facing internal edge, and the second catch comprises the proximally facing internal edge.
Date Recue/Date Received 2021-07-26 1.0
Date Recue/Date Received 2021-07-26 1.0
7. The system of claim 6, wherein the distally facing shoulder abuts the proximally facing internal edge to limit advancement of the puncturing tip out of the introducer distal end beyond the predetermined distance.
8. The system of claim 1, wherein the predetermined distance is between about 1 mm and about 3 mm.
9. The system of claim 1, wherein the puncture device distal end is sharpened to provide the puncturing tip.
10. The system of claim 1, wherein the introducer has an introducer length between the introducer proximal end and the introducer distal end;
the puncture device has a puncture device length between the puncture device proximal end and the puncture device distal end; and the introducer length is less than the puncture device length.
the puncture device has a puncture device length between the puncture device proximal end and the puncture device distal end; and the introducer length is less than the puncture device length.
11. The system of claim 1, wherein the introducer distal end is blunt.
12. The system of claim 1, wherein the introducer comprises a metallic tube embedded in a polymeric sheathing.
13. The system of claim 1, wherein at least one of the introducer and the puncture device comprises a radiopaque marker.
14.A method for pericardial puncture, comprising:
a. positioning a distal end of an introducer adjacent a pericardium;
b. advancing a puncturing tip of a puncture device out of the introducer to puncture the pericardium with the puncturing tip; and c. engaging the introducer with the puncture device to prevent advancement of the puncturing tip out of the introducer beyond a predetermined distance.
Date Recue/Date Received 2021-07-26
a. positioning a distal end of an introducer adjacent a pericardium;
b. advancing a puncturing tip of a puncture device out of the introducer to puncture the pericardium with the puncturing tip; and c. engaging the introducer with the puncture device to prevent advancement of the puncturing tip out of the introducer beyond a predetermined distance.
Date Recue/Date Received 2021-07-26
15. The method of claim 14, wherein step c. comprises engaging a first catch of the puncture device with a second catch of the introducer.
16.The method of claim 14, wherein step c. comprises abutting a shoulder of the puncture device with an edge of the introducer.
17. The method of claim 14, wherein the predetermined distance is between about 1 mm and about 3 mm.
18. The method of claim 14, wherein step b. comprises advancing a sharpened distal end of the puncture device out of the introducer.
19. The method of claim 14 further comprising, prior to step b., confirming the position of the distal end of the introducer using fluoroscopy.
20. The method of claim 14, further comprising, after step c., withdrawing the puncture device from the introducer.
Date Recue/Date Received 2021-07-26
Date Recue/Date Received 2021-07-26
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202063058785P | 2020-07-30 | 2020-07-30 | |
| US63/058,785 | 2020-07-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA3125876A1 true CA3125876A1 (en) | 2022-01-30 |
Family
ID=80115808
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA3125876A Pending CA3125876A1 (en) | 2020-07-30 | 2021-07-26 | System of medical devices and method for pericardial puncture |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA3125876A1 (en) |
-
2021
- 2021-07-26 CA CA3125876A patent/CA3125876A1/en active Pending
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